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    • Application(array)
      • id376
      • user_id255
      • trial_status_id6
      • abstract_of_study<p>\n <strong><u> SYNOPSIS</u></strong><br />\n Study title<br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n Trial Design Immediate vs delayed study<br />\n <u>Study Population</u><br />\n HIV-1/2 negative, females at low risk of HIV aged 18-50 years of<br />\n age.<br />\n Planned Sample Size 44<br />\n Planned Trial Period 13 months after recruitment<br />\n Primary Outcome To measure cervical mucosal immune activation after VZVvaccination<br />\n in the context of VZV-effector responses.<br />\n <u>Secondary Objective</u><br />\n To measure the effector VZV-specific CD8+ T cells at the rectal<br />\n mucosa after VZV vaccination;<br />\n To compare the immune activation observed in mucosal tissues<br />\n and in blood.<br />\n <u>Primary Endpoint</u><br />\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.<br />\n <u>Secondary endpoints</u><br />\n An increase in the percentage of VZV-specific CD8+T cells at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. This increase must be significantly different<br />\n from the change observed in the same period for the delayed group<br />\n in order to be considered associated to vaccination.<br />\n To compare the expression of co-receptors and activation markers<br />\n such as CCR5, α4β7, CD38, CD69 and HLA-DR in blood and<br />\n cervical CD4+T cells at 3 months after immunization with<br />\n varicella vaccine.<br />\n Investigational<br />\n Medicinal Product<br />\n Zostavax®<br />\n KAVI-VZV-001 Version 2.0 (01 September 2014) Page 9 of 49<br />\n Dose Zostavax® >19,400 PFU (Z)<br />\n Route Subcutaneous needle injection<br />\n <u>Study Design</u><br />\n Vaccination Period<br />\n Group No. Wk 0 Wk 12<br />\n Immediate 22 Z -<br />\n Delayed 22 - Z<br />\n <u>Follow-Up Duration</u><br />\n After the vaccination with Zostavax®, the delayed groups will be<br />\n followed-up for 9 months and the immediate groups for 12<br />\n months.<br />\n Trial Sponsor University of Toronto, Canada</p>\n
      • study_title<p style=\"text-align: justify;\">\n <br />\n <u><strong>Study title</strong></u><br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n  </p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/01/02
      • version_noVersion No: 2.0 (01 September 2014)
      • date_of_protocol01-09-2014
      • study_drugVaricella Zoster Virus vaccine Zostavax® (Merck)
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameZostavax®
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressEmutisya@kaviuon.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
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      • applicant_prev_data(null)
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      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
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      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKAVI-Institute of Clinical Research (KAVI-ICR) University of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya
      • declaration_date115-01-2015
      • declaration_principal_investigatorProfessor Walter Jaoko, MB, ChB, MTropMed, PhD, Site Principal Investigator
      • declaration_date215-01-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1. Healthy females, as assessed by a medical history, physical examination and<br />\n laboratory tests, with no chronic medical condition;<br />\n 2. Aged at least 18 years on the day of screening and no greater than 50 years on the day<br />\n of the first vaccination.<br />\n 3. VZV-seropositive, as assessed by the VIDAS assay.4. Ability to comply with the study requirements and available for follow-up for the<br />\n planned duration of the study.<br />\n 5. In the opinion of the Principal Investigator or designee, the volunteer has understood<br />\n the information provided and signed the consent document.<br />\n 6. Willing to undergo HIV testing, HIV counselling and receive HIV test results.<br />\n 7. For women with potential to become pregnant, willing to use effective contraception<br />\n or barrier methods to avoid pregnancy during the study (spermicides or chemicals are<br />\n not allowed).<br />\n  </p>\n
      • principal_exclusion_criteria<p>\n Any relevant abnormality on history or examination including history of tuberculosis,<br />\n immunodeficiency or autoimmune disease, or use of systemic corticosteroids,<br />\n immunosuppressive, antiviral, anticancer or other medication that, in the opinion of the<br />\n Principal Investigator or designee, is clinically significant. (Note: use of inhaled steroids for<br />\n asthma or use of topical steroids for localized skin conditions will not exclude a volunteer<br />\n from participation) and/or:<br />\n 1. A high risk for HIV-acquisition defined by the experience of any of the follow<br />\n situations:<br />\n a) Had unprotected vaginal or anal sex with a known HIV-1-infected person, a<br />\n person known to be at high risk for HIV or a casual partner (i.e., no continuing,<br />\n established relationship) within the previous 6 months;<br />\n b) Engaged in sex work for money or drugs within the previous 6 months;<br />\n c) Used injection drugs;<br />\n d) Abuse of illicit or prescribed drugs, including alcohol;<br />\n e) Acquired one of the following sexually transmitted infection: chlamydia,<br />\n gonorrhoea and syphilis in the last 12 months;<br />\n f) More than 1 sexual partner within the last 6 months;<br />\n g) New sexual partner within the last 3 months.<br />\n 2. Persistent or recurrent bacterial vaginosis or vaginal candidiasis unresponsive to<br />\n therapy (2 consecutive attempts by study team).<br />\n 3. Confirmed HIV-1 or HIV-2 infection.<br />\n 4. Any clinically significant acute or chronic medical condition that is considered<br />\n progressive or, in the opinion of the Principal Investigator or designee, would make<br />\n the volunteer unsuitable for the study (active or underlying diabetes, gastrointestinal,<br />\n cardiovascular, malignancy, neurological, psychiatric, metabolic, renal, hepatic,<br />\n respiratory, auto-immune diseases, psoriasis, primary and acquired immunodeficiency<br />\n KAVI-VZV-</p>\n<p>\n status and rectal problems).<br />\n 5. Any of the following abnormal laboratory parameters except that one abnormal<br />\n laboratory test may be repeated once if thought to be due to a temporary condition:<br />\n Haematology<br />\n a) Haemoglobin < 9.0 g/dl<br />\n b) Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 100 /l, ≥ 550 /l)<br />\n Coagulation<br />\n - INR <1.0 or >1.5<br />\n 6. Evidence of coagulopathy demonstrated by a reduced level of platelets or a history of<br />\n 3 or more episodes of uncontrolled bleeding from their mouth, nose or other mucous<br />\n membrane (marked by excessive bleeding of more than 30 min).<br />\n 7. A positive pregnancy test or breast-feeding at screening; for the participants with<br />\n reproductive potential, unwilling to use an effective method of preventing pregnancy<br />\n during the study.<br />\n 8. Receipt of vaccine within the previous 2 months or planned receipt at any time until 6<br />\n months after vaccination with Zostavax®.<br />\n 9. Receipt of blood transfusion or blood products within the previous 6 months.<br />\n 10. Participation in another clinical trial currently or within the previous 3 months.<br />\n 11. History of severe or very severe local or systemic reactogenicity events after<br />\n vaccination, or history of severe or very severe allergic reactions.<br />\n 12. History of toxic shock syndrome.<br />\n 13. Confirmed diagnosis of acute or chronic hepatitis B virus infection (spontaneous<br />\n clearance leading to natural immunity, indicated by antibodies to core + antigens, is<br />\n not an exclusion criterion); confirmed diagnosis of hepatitis C virus infection.<br />\n 14. Immunosuppressive medications 30 days before or during the study period.<br />\n 15. History of anaphylactic/anaphylactoid reaction to neomycin (each dose of<br />\n reconstituted vaccine contains trace quantities of neomycin).<br />\n 16. Major psychiatric illness including any history of schizophrenia or severe psychosis,<br />\n bipolar disorder, suicidal attempt or ideation in the previous 3 years.<br />\n 17. Contra-indication for undergoing a biopsy due to bleeding diathesis, haemorrhoids,<br />\n mucosal infection at the biopsy site, medication that interfere with clotting (e.g.<br />\n warfarin or heparin) – both clinical and laboratory.<br />\n 18. Any other reason as determined by the Principal Investigator</p>\n
      • primary_end_points<p>\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifycharacterization of mucosal immune response.
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td>\n <p>\n Name</p>\n </td>\n <td>\n <p>\n Designation</p>\n </td>\n <td>\n <p>\n Qualifications</p>\n </td>\n <td>\n <p>\n Years in research</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Omu Anzala</p>\n </td>\n <td>\n <p>\n Co-Investigator</p>\n </td>\n <td>\n <p>\n MBChB, diploma epidemiology, PhD medical microbiology and infectious disease, post doc fellow molecular immunology group institute of molecular medicine oxford university</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Walter Jaoko</p>\n </td>\n <td>\n <p>\n Principal Investigator</p>\n </td>\n <td>\n <p>\n MBChB, MSc tropical medicine, diploma research methodology, PhD medical mirobiology</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Kirana Bhatt</p>\n </td>\n <td>\n <p>\n Consultant Physician</p>\n </td>\n <td>\n <p>\n MBChB, MMed internal medicine, MSc clinical tropical medicine, PhD</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gina Ouattara</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB</p>\n </td>\n <td>\n <p>\n 5.5</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gaudensia Mutua</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB, MPH</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Emmanuel Museve</p>\n </td>\n <td>\n <p>\n Study clinician</p>\n </td>\n <td>\n <p>\n Diploma clinical medicine and surgery</p>\n </td>\n <td>\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jacquelyn Nyange</p>\n </td>\n <td>\n <p>\n Study coordinator - regulatory</p>\n </td>\n <td>\n <p>\n KRN, BA psychology, MSc clinical psychology</p>\n </td>\n <td>\n <p>\n 11</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Elizabeth Mutisya</p>\n </td>\n <td>\n <p>\n Study coordinator – clinic level</p>\n </td>\n <td>\n <p>\n KRCHN, BA psychology and sociology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Hilda Ogutu</p>\n </td>\n <td>\n <p>\n Senior study nurse</p>\n </td>\n <td>\n <p>\n KRM, KRCHN, BScN</p>\n </td>\n <td>\n <p>\n 13</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Ndambuki</p>\n </td>\n <td>\n <p>\n Study nurse</p>\n </td>\n <td>\n <p>\n KRCHN, HND counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Roselyne Malogo</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n KRCHN, certificate in conflict resolution, BA community development</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Mahira</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n ECN, diploma in counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Bashir Farah</p>\n </td>\n <td>\n <p>\n Laboratory manager</p>\n </td>\n <td>\n <p>\n HND virology, MSc Virology</p>\n </td>\n <td>\n <p>\n 18</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jackton Indagasi</p>\n </td>\n <td>\n <p>\n Laboratory quality assurance manager</p>\n </td>\n <td>\n <p>\n PGD infectious disease, MSc infectious disease</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Robert Langat</p>\n </td>\n <td>\n <p>\n Laboratory and site Safety officer</p>\n </td>\n <td>\n <p>\n BSc medical laboratory technology</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Simon Ogolla</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n HND microbiology</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Irene Mwangi</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n Diploma laboratory technology, BSc laboratory technology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Ruth Chirchir</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n BSc biological sciences</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Moses Muriuki</p>\n </td>\n <td>\n <p>\n Data/IT Manager</p>\n </td>\n <td>\n <p>\n BSc software engineering</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Laura Lusike</p>\n </td>\n <td>\n <p>\n Data assistant</p>\n </td>\n <td>\n <p>\n BA home economics</p>\n </td>\n <td>\n <p>\n 14</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Other staff:</p>\n <p>\n Administrative, Finance and support staff</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n Site facilities:<br />\n - Reception<br />\n - Waiting room for volunteers<br />\n - Counseling rooms - 2<br />\n - Patient examination rooms – 3<br />\n - Study records filing room – limited access using swipe card<br />\n - Laboratories – swipe access<br />\n o safety laboratory<br />\n o immunology laboratory<br />\n - Data room – limited access with swipe card<br />\n o Pre – archive room – swipe card access<br />\n o Data entry computers – 4<br />\n o Online and offline data entry capabilities<br />\n o Data faxing<br />\n o Internet – upload and download bandwidth of 1MB/second and backup modems from mobile service providers<br />\n o Backup UPS of 4 – 6 hours and backup generator<br />\n - Kitchenette – for staff and volunteer refreshments<br />\n - Meeting room<br />\n Emergency facilities:<br />\n - One of the patient examination rooms is equipped as an emergency room with oxygen tank and mask, suction pump machine with suction tubes, defibrillator, nebulizer, laryngoscope, endotracheal tubes, airway, adult ambu bag and mask, giving sets.<br />\n - Emergency stretcher<br />\n - Emergency drugs in stock –<br />\n o Parenteral - hydrocortisone, adrenaline, paracetamol, hyosine, atropine, lidocaine, lignocaine, aminophylline, sodium bicarbonate, metoclopramide, diazepam, chlorpheniramine, calcium gluconate,<br />\n o Salbutamol nebulizer solution<br />\n o IV fluids – 5% dextrose, 50% dextrose, normal saline<br />\n o Post exposure prophylaxis – combivir and kaletra<br />\n - Patients can then be transferred to Kenyatta National Hospital emergency department or admitted to the wards for further care.</p>\n
      • other_details_explanation<p>\n In this trial we ai to investigate the potentail of using varicella-zoster virus (VZV) as a vector for an hiv-vaccine by first characterising the mucosal immune response induced by VZV vaccination. As we intend to conduct the future VZV-HIV phase 1 clinical trial ( with VZV carrying HIV genes) in kenya it is important that the study that sets the basis for this future be also conducted in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n University of Toronto research ethics committee, !st Dec 2014.</p>\n
      • other_details_regulatory_approved<p>\n KNH/UON Ethics research committee.</p>\n<p>\n Approval date:23rd oct 2014.</p>\n<p>\n Sites: KAVI-ICR, Nairobi Kenya.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration13 months after enrollment.
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKAVI-INSTITUTE OF CLINICAL RESEARCH (KAVI-ICR)
      • single_site_physical_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya.
      • single_site_contact_personProfessor Walter Jaoko,
      • single_site_telephone+254-2-2717694/+254727555254
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listKENYA\nCANADA
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide44
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProf Walter Jaoko
      • investigator1_middle_name
      • investigator1_family_name Jaoko
      • investigator1_qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
      • investigator1_professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
      • investigator1_telephone+254-2-2717694/+254727555254
      • investigator1_emailwjaoko@kaviuon.org
      • organisations_transferred_Yes
      • number_participants44
      • notification<p>\n none.</p>\n
      • approval_date10-03-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-01-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-04-26 16:23:36
      • created2015-01-15 09:38:39
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id256
        • application_id376
        • given_nameProf Walter Jaoko
        • middle_name
        • family_nameJaoko
        • qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
        • professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
        • telephone+254-2-2717694/+254727555254
        • emailwjaoko@kaviuon.org
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
    • SiteDetail(array)
      • 0(array)
        • id307
        • application_id376
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id194
        • application_id376
        • sponsorUniversity of Toronto
        • sponsor_type(null)
        • contact_personDr. Kelly S. MacDonald, MD, FRCPC, Chief Investigator
        • addressDepartment of Medicine and Immunology University of Toronto 1 King’s College Circle Medical Sciences Building, Room 6360 Toronto ON, M5S 1A8 Canada.
        • telephone_number(416) 946-3733
        • fax_number(416) 978-8765
        • cell_number(416) 946-3733
        • email_addresskelly.macdonald@utoronto.ca
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
  • 1(array)
    • Application(array)
      • id350
      • user_id224
      • trial_status_id7
      • abstract_of_study<p>\n Acute venous thromboembolism (i.e. deep-vein thrombosis [DVT] or pulmonary<br />\n embolism [PE]) is a common disorder with an annual incidence of approximately 1<br />\n or 2 cases per 1000 persons in the general population and is the third most common<br />\n cause of vascular death after myocardial infarction and stroke. The current standard<br />\n treatment for DVT is overlapping parenteral anticoagulation (e.g. LMWH) and a<br />\n vitamin K antagonist (e.g. warfarin). Parenteral anticoagulation needs to be<br />\n continued for 5 to 7 days, at least until an INR of 2.0 has been obtained, followed by<br />\n a minimum of 3 months of treatment with the vitamin K antagonist. Treatment with<br />\n vitamin K antagonists requires frequent monitoring of the international normalized<br />\n ratio (INR), and multiple interactions of vitamin K antagonists with foods and other<br />\n drugs have been reported. The duration of treatment is determined by individual risk<br />\n factors of the patient.<br />\n Rivaroxaban is a direct factor Xa inhibitor, and has been approved first in the<br />\n prevention of venous thromboembolism after elective hip and knee replacement<br />\n surgery. It does not require routine laboratory monitoring and has no food<br />\n interactions and only a few drug interactions compared to standard of care.<br />\n As part of the development program, the EINSTEIN clinical trial program was<br />\n designed to evaluate the use of rivaroxaban for the acute treatment and secondary<br />\n prevention of DVT (EINSTEIN-DVT) and PE (EINSTEIN-PE) and in long-term<br />\n secondary prevention of recurrent DVT and PE (EINSTEIN-EXT). A unique aspect<br />\n of the EINSTEIN-DVT and PE studies is the use of rivaroxaban as a single agent<br />\n (single drug approach) in contrast to the use of intravenous anticoagulants and<br />\n VKAs.<br />\n The EINSTEIN-DVT study demonstrated that rivaroxaban is at least as effective as<br />\n the current standard therapy with similar safety, in the treatment and secondary<br />\n prevention of DVT. The EINSTEIN PE study demonstrated non-inferior efficacy of<br />\n rivaroxaban compared to standard of care with similar rates of major and clinically<br />\n relevant non-major bleeding. EINSTEIN PE further demonstrated a significant<br />\n reduction of major bleeding events in patients treated with rivaroxaban compared to<br />\n standard of care. EINSTEIN-EXT demonstrated that continued treatment with<br />\n rivaroxaban after 6 or 12 months initial treatment is superior in preventing<br />\n recurrences, as compared with placebo, and has an acceptable risk of bleeding.<br />\n At the time of writing, rivaroxaban is approved by the EMA, the FDA, Singapore,<br />\n Malaysia, Indonesia, Philippines, Taiwan, Korea and Mexico, Brazil, Argentina,<br />\n Chile, Colombia, Peru, Ecuador, Uruguay, and several other countries in Latin<br />\n America as well as in the EMEA region Saudi Arabia, Egypt, Middle Africa, UAE,<br />\n Kuwait, Qatar, Turkey, Jordan, Lebanon, Russia, Kazakhstan and Algeria for the<br />\n treatment of acute DVT, PE and recurrent VTE following DVT or PE in adults. The<br />\n approved dose is 15mg bid for the first 21 days followed by 20mg od for the<br />\n continuing treatment period. Further dosing information are listed in detail in the<br />\n Summary of Product Characteristics (SmPC). In the European Union and other<br />\n countries, rivaroxaban is the first agent that allows treatment of thrombotic events<br />\n with a single drug approach. Treatment with rivaroxaban can be already initiated at<br />\n diagnosis and does not require intravenous/subcutaneous heparin or VKA anymore.<br />\n If the decision is made to switch treatment from rivaroxaban to current standard of<br />\n care, adequate anticoagulation has to be ensured. In patients converting from rivaroxaban to VKA, VKA should be given concurrently until the INR is ≥2.0.<br />\n Patients converting from rivaroxaban to parenteral anticoagulation should receive<br />\n the parenteral anticoagulant at the time originally scheduled for the intake of<br />\n rivaroxaban.<br />\n Bayer conducts the XALIA LEA study to yield complementary post-authorization<br />\n information in rivaroxaban or standard therapy patients under real-life conditions.</p>\n
      • study_title<p>\n XALIA LEA- Xarelto® for Long-term and<br />\n Initial Anticoagulation in Venous<br />\n Thromboembolism (VTE) in Latin America,<br />\n EMEA and Asia</p>\n
      • laymans_summary(null)
      • short_titleRivaroxaban for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
      • protocol_noECCT/14/12/01
      • version_noXA1402 (Impact No. 17237), Protocol Version 1.0
      • date_of_protocol18-02-2014
      • study_drugBay 59-7939, Rivaroxaban, Xarelto®
      • disease_conditionTreatment of deep vein thrombosis (DVT)
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameRivaroxaban
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressselina.musalia@bayer.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantJohn Mwangi (john.mwangi@bayer.com)
      • declaration_date103-12-2014
      • declaration_principal_investigatorDr. Anne Njambi,Dr Allibhoy Ali, Dr Charles Kariuki,Dr Martin Wanyoike
      • declaration_date203-12-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n ï‚· Female or male patients, who are at >=18 years<br />\n ï‚· Diagnosis of acute DVT and/or PE, objectively confirmed<br />\n ï‚· Indication for anticoagulation therapy for at least 12 weeks<br />\n ï‚· Willing to participate in this study and available for follow-up</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria must be read in conjunction with the local product information.<br />\n Patients who are found to receive treatment contrary to the local product information<br />\n will not be excluded. Depending on the number of patients receiving rivaroxaban<br />\n contrary to the local product information these patients can be analyzed in a separate<br />\n analysis. Further details will be described in the SAP.<br />\n  </p>\n
      • primary_end_points<p>\n Major bleedings defined as overt bleeding associated with:<br />\n  A fall in hemoglobin of ≥2 g/dL, or<br />\n  A transfusion of ≥2 units of packed red blood cells or whole blood, or<br />\n  Occurrence at a critical site: intracranial, intra-spinal, intraocular,<br />\n pericardial, intra-articular, intra-muscular with compartment syndrome,<br />\n retroperitoneal<br />\n  Death<br />\n o Symptomatic recurrent venous thromboembolic events confirmed by objective<br />\n diagnostic tools<br />\n o All-cause mortality<br />\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Prime Care Heart Clinic. Number of Staff:3</p>\n<p>\n Dr Silversteins Clinic.Number of Staff: 2</p>\n<p>\n Nairobi Cardiovascular Clinic.Number of Staff: 3</p>\n<p>\n Agakhan Kisumu:Number of staff 1</p>\n<p>\n Please refer to CVs attached.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n A similar study the Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonist for the prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study was conducted to evaluate the efficacy and safety of rivaroxaban compared to the VKA warfarin in the prevention of thromboembolic events in subjects with non-valvular AF was conducted in the host country.</p>\n<p>\n The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT and/or PE in routine clinical practice use in Latin America, Eastern Europe, Middle East and Africa.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration12 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states10
      • number_of_sitesMultiple
      • multi_country_listLatin America, Eastern Europe,Middle East and Asia
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide2500
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDavid Kuria Kamau
      • investigator1_middle_nameKuria
      • investigator1_family_nameKamau
      • investigator1_qualificationMBChB , M.Med
      • investigator1_professional_addressPrime care heart clinic ,Nairobi Hospital, Nairobi Kenya
      • investigator1_telephone+254 722 578 308
      • investigator1_emailkuriakamau@gmail.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date27-01-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-12-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-05-05 10:34:58
      • created2014-11-06 14:24:03
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id242
        • application_id350
        • given_nameAnne Njeri Mugera
        • middle_nameNjambi
        • family_nameMugera
        • qualificationMBChB, Mmed
        • professional_addressDr. Silversteins Clinic, Nairobi Hospital ,Nairobi Kenya.
        • telephone+254 722 747 695
        • emaildrannemugeraknh@gmail.com
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
      • 1(array)
        • id243
        • application_id350
        • given_nameDr. Martin N Wanyoike
        • middle_nameNjoroge
        • family_nameWanyoike
        • qualificationMBChB,M.Med ,CTM
        • professional_addressPrime Care Heart Clinic , Nairobi Hospital, Nairobi Kenya
        • telephone+254 720 921 553
        • emailprimecareheartclinic@gmail.com
        • created2014-11-06 15:07:54
        • modified2014-12-04 10:39:27
      • 2(array)
        • id244
        • application_id350
        • given_nameCharles Muthui Kariuki
        • middle_nameMuthui
        • family_nameKariuki
        • qualificationMBChB,MRCP,M.Med,FRCP
        • professional_addressNairobi Cardiovascular Clinic, NairobI Hospital ,Nairobi ,Kenya
        • telephone+254 733 370 057
        • emailckthreesk@gmail.com
        • created2014-11-06 15:13:05
        • modified2014-12-04 10:39:27
      • 3(array)
        • id245
        • application_id350
        • given_nameFEROZ ALI
        • middle_name
        • family_nameAllibhoy
        • qualificationMBBS
        • professional_addressP.O Box 530 Kisumu
        • telephone(057)2020005 / 2023300
        • emaildr.f.allibhoy@live.com
        • created2014-11-10 16:11:56
        • modified2014-12-04 10:39:27
    • SiteDetail(array)
      • 0(array)
        • id293
        • application_id350
        • county_id47
        • site_namePrimecare Heart Clinic
        • physical_addressPrime care Heart clinic Nairobi Hospital , Nairobi , Kenya
        • contact_detailsP.O.BOX 19552-00202 NAIROBI
        • contact_personDr. Martin Wanyoike
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id294
        • application_id350
        • county_id47
        • site_nameDr. Silversteins Clinic
        • physical_addressDr.Silversteins Clinic , Nairobi Hospita Nairobi Kenya.
        • contact_details+254 722 747 695
        • contact_personDr.Anne Mugera
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 15:35:33
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id295
        • application_id350
        • county_id47
        • site_nameNairobi Cardiovascular Clinic
        • physical_addressNairobi Cardiovascular Clinic,Nairobi Hospital, Nairobi Kenya
        • contact_details+254 733 370 057
        • contact_personDr.Charles Kariuki
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 15:35:33
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id296
        • application_id350
        • county_id42
        • site_nameAgah Khan Kisumu
        • physical_addressKisumu
        • contact_detailsP.O Box 530 Kisumu
        • contact_personDr Allibhoy Feroz Ali
        • site_capacity(null)
        • misc(null)
        • created2014-11-10 16:13:39
        • modified2014-12-04 10:39:28
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id185
        • application_id350
        • sponsorBayer HealthCare AG, Germany
        • sponsor_type(null)
        • contact_personChristopher Maina Wairegi
        • address30321-00100 Thika Road/Outering road , Ruaraka
        • telephone_number+254 20 8600000
        • fax_number+254 20 8600010
        • cell_number+254 700 390 311
        • email_addresschristopher.wairegi@bayer.com
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
  • 2(array)
    • Application(array)
      • id351
      • user_id77
      • trial_status_id5
      • abstract_of_study<div>\n DESIGN A5297 is a phase I/II, open-label, proof of concept, two-step, two-arm, controlled randomized clinical trial (RCT) to test the superiority of lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) to non-nucleoside reverse transcriptase (nNRTI)-based ART for clearance of Plasmodium falciparum (Pf) subclinical parasitemia (SCP).</div>\n<div>\n Participants will be followed for 30 days in order to evaluate parasitemia clearance, Pf parasitemia, gametocytemia, and plasmepsin sequencing. Participants will have blood collected twice at entry, day 3, 6, 9, 12, 20, and 25 and three times for day 15 and day 30. Therefore, on most study days, participants will need to either remain at the clinic for an extended period of time or be willing to return two or three times at approximately 8-hour intervals (see section 6.2 for details).</div>\n<div>\n DURATION 30 days: Step 1= days 1-15; Step 2= days 16-30</div>\n<div>\n SAMPLE SIZE 52 participants</div>\n<div>\n POPULATION HIV infected adults at least 18 years of age with CD4+ counts >200 and < 350 cells/mm3 who will be starting ART and have Pf SCP. Individuals with signs or symptoms suggestive of concurrent opportunistic infections, pulmonary or gastrointestinal infections, or clinical malaria will be excluded.</div>\n<div>\n REGIMENS Step 1</div>\n<div>\n Participants will be randomized 1:1 to one of the following arms for 15 days:</div>\n<div>\n Arm A: LPV/r-based ART</div>\n<div>\n Arm B: nNRTI-based ART</div>\n<div>\n Step 2</div>\n<div>\n All participants will receive an nNRTI-based ART and TMP/SMX prophylaxis to take from day 16 through day 30.</div>\n<div>\n  </div>\n<div>\n <div>\n <div>\n 1.0 HYPOTHESES AND STUDY OBJECTIVES</div>\n <div>\n 1.1 Primary Hypothesis</div>\n <div>\n In HIV-infected participants with CD4+ counts >200 and <350 cells/mm3, lopinavir/ritonavir (LPV/r)-based ART will be superior to nNRTI-based ART in PCR-defined Plasmodium falciparum (Pf) subclinical parasitemia (SCP) clearance after 15 days of therapy.</div>\n <div>\n 1.2 Secondary Hypotheses</div>\n <div>\n 1.2.1 Pf parasite densities in participants with Pf SCP who have received 15 days (Step 1) of LPV/r-based ART will be lower than those receiving nNRTI-based ART.</div>\n <div>\n 1.2.2 Time to clearance in participants with Pf SCP will be shorter in participants who have received 15 days (Step 1) of LPV/r-based ART compared with those receiving nNRTI-based ART.</div>\n <div>\n 1.2.3 Participants who have cleared Pf SCP at entry to Step 2 will remain without Pf SCP at day 30 evaluation regardless of the arm to which they were randomized in Step 1.</div>\n <div>\n 1.2.4 Participants with continued Pf SCP at entry to Step 2 will have lower Pf parasite densities at day 30 evaluation compared to day 15 evaluation regardless of the arm they were randomized to in Step 1.</div>\n <div>\n 1.2.5 Gametocyte densities will be lower in participants with Pf SCP who have received 15 days (Step 1) of LPV/r-based compared with nNRTI-based ART.</div>\n <div>\n 1.2.6 Participants with continued Pf SCP at entry to Step 2 will have a higher Pf gametocyte density at day 30 evaluation compared to day 15 evaluation regardless of the arm to which they were randomized in Step 1.</div>\n <div>\n 1.2.7 Mutations in the Pf plasmepsin region in participants receiving LPV/r-based ART will be identified after 15 days (Step 1) of therapy.</div>\n <div>\n 1.3 Primary Objective</div>\n <div>\n To compare the proportions of Pf SCP clearance between LPV/r-based and nNRTI based ART in participants after 15 days of therapy (Step 1).</div>\n <div>\n 1.4 Secondary Objectives</div>\n <div>\n 1.4.1 To compare time to Pf SCP clearance in participants with Pf SCP who have received 15 days of LPV/r-based and nNRTI-based ART.</div>\n <div>\n 1.4.2 To compare Pf parasite densities in participants with Pf SCP who have received 15 days of LPV/r-based and nNRTI-based ART.</div>\n <div>\n 1.4.3 To estimate changes in Pf parasite densities from day 1 to day 30 in four cohorts: (1) randomized to nNRTI-based ART with continued Pf SCP at day 15, (2) randomized to nNRTI-based ART with clearance of Pf SCP at day 15, (3)</div>\n <div>\n <div>\n randomized to LPV/r-based ART with continued Pf SCP at day 15, (4) randomized to LPV/r-based ART with clearance of Pf SCP at day 15.</div>\n <div>\n 1.4.4 To compare Pf gametocyte densities in participants with Pf SCP who have received 15 days of LPV/r-based and nNRTI-based ART.</div>\n <div>\n 1.4.5 To estimate changes in Pf gametocyte densities from day 1 to day 30 in four cohorts: (1) randomized to nNRTI-based ART with continued Pf SCP at day 15, (2) randomized to nNRTI-based ART with clearance of Pf SCP at day 15, (3) randomized to LPV/r-based ART with continued Pf SCP at day 15, (4) randomized to LPV/r-based ART with clearance of Pf SCP at day 15.</div>\n <div>\n 1.4.6 To describe safety and clinical outcomes in participants with Pf SCP who have received 15 days of LPV/r-based and nNRTI-based ART.</div>\n <div>\n 1.4.7 To describe safety and clinical outcomes in participants who enter Step 2 with and without Pf SCP.</div>\n <div>\n 1.4.8 To evaluate whether exposure of Pf parasites to LPV/r results in the selection of signature mutations within the plasmepsin region.</div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • study_title<p>\n <span style=\"font-size: 12px;\">An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of Plasmodium falciparum Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and < 500 cells/mm3</span></p>\n
      • laymans_summary(null)
      • short_titleA5297
      • protocol_noECCT/14/11/02
      • version_no1.0
      • date_of_protocol29-02-2012
      • study_drugLopinavir/ritonavir, Efavirenz, Trimethoprim/Sulphamethoxazole
      • disease_conditionMalaria and HIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameLopinavir/ritonavir, Efavirenz, Nevirapine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseayuo@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantAMOS K. O. RAGANG\', KEMRI/CDC CLINICAL RESEARCH CENTRE, PO BOX 1578-40100 KISUMU
      • declaration_date101-12-2014
      • declaration_principal_investigatorDR. VICTOR AKELO, KEMRI/CDC CLINICAL RESEARCH CENTRE, PO BOX 1578-40100 KISUMU
      • declaration_date201-12-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Step 1 Inclusion Criteria</p>\n<ul>\n <li>\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</li>\n</ul>\n<p>\n Note: The term “licensed” refers to a US FDA-approved kit, which is required for all US sites and recommended for non-US ones. For non-US sites that are unable to obtain an FDA-approved kit, a kit that has been certified or licensed by an oversight body within that country and validated internally is acceptable.</p>\n<p>\n WHO (World Health Organization) and CDC (Center for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<ul>\n <li>\n CD4+ count > 200 and < 350 cells/mm3 obtained within 30 days prior to study entry at a DAIDS-approved laboratory.</li>\n <li>\n <em>Pf </em>SCP confirmed in a laboratory approved to conduct parasitemia microscopy.</li>\n</ul>\n<p>\n Note: <em>Pf </em>SCP will be defined as meeting all three of the following criteria within 72 hours prior to study entry:</p>\n<ul>\n <li>\n Microscopy confirmed parasitemia (see section 6.3.6 and the A5297 Manual of Procedures [MOPS])</li>\n <li>\n An oral temperature < 37.5°C temperature</li>\n <li>\n The absence of Grade 2 or greater signs or symptoms thought to be related to clinical malaria including:</li>\n</ul>\n<p>\n a. headache</p>\n<p>\n b. malaise or fatigue</p>\n<p>\n c. abdominal discomfort</p>\n<p>\n d. muscle or joint pain</p>\n<p>\n e. fever</p>\n<p>\n f. chills</p>\n<p>\n g. perspiration</p>\n<p>\n h. anorexia</p>\n<p>\n i. vomiting</p>\n<p>\n j. other signs or symptoms thought to be related to clinical malaria</p>\n<ul>\n <li>\n The following laboratory values obtained within 14 days prior to study entry:</li>\n</ul>\n<p>\n  </p>\n<ul style=\"margin-left: 40px;\">\n <li>\n Hemoglobin  7.0 g/dL</li>\n <li>\n  Estimated creatinine clearance of ≥60 mL/min.</li>\n</ul>\n<p>\n Note: Calculation program can be found on DMC website (http://www.fstrf.org/ACTG/index.html).</p>\n<ul style=\"margin-left: 40px;\">\n <li>\n Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ï‚£ 2.5 ï‚´ ULN</li>\n <li>\n Hepatitis B surface antigen (HBsAg) negative within 30 days prior to entry.</li>\n <li>\n Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test performed within 72 hours prior to entry.</li>\n</ul>\n<p>\n NOTE: Female study volunteers of reproductive potential are defined as women who have reached menarche or who have not been post-menopausal for at least 24 consecutive months {i.e., who have had menses within the preceding 24 months and have not undergone a sterilization procedure (eg, hysterectomy, bilateral oophorectomy, or salpingectomy)}.</p>\n<ul>\n <li>\n All study volunteers must agree not to participate in a conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for study duration.</li>\n</ul>\n<p>\n  </p>\n<p>\n If participating in sexual activity that could lead to pregnancy, all study volunteers must agree to use two reliable forms of contraceptive simultaneously while receiving protocol-specified medications. One form of contraceptive must be a barrier method if a participant receives EFV. Participants must agree to continue the use of two contraceptives for 6 months after stopping EFV and 6 weeks after stopping all other protocol-specified medications.</p>\n<p>\n Note: Female participants who are unable to meet the contraception requirements for EFV should be encouraged to consider NVP.</p>\n<p>\n Study volunteers who are not of reproductive potential (girls who have not reached menarche, or women who have been post-menopausal for at least 24 consecutive months, or women who have undergone hysterectomy, bilateral oophorectomy or salpingectomy, or men who have documented azoospermia) are eligible without requiring the use of a contraceptive. Acceptable documentation of sterilization, other contraceptive methods, and menopause are written documentation or oral communication from a clinician or clinician’s staff documented in source documents of one of the following:</p>\n<p>\n ï‚· Physician report/letter</p>\n<p>\n ï‚· Operative report or other source documentation in the patient record</p>\n<p>\n ï‚· Discharge summary</p>\n<p>\n ï‚· Laboratory report of azoospermia (is required to document successful vasectomy)</p>\n<p>\n ï‚· FSH measurement elevated into the menopausal range as established by the reporting laboratory for EFV and per participant’s history for all other drugs.</p>\n<p>\n  </p>\n<ul>\n <li>\n Men and women age  18 years.</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n Ability and willingness of participant or legal guardian/representative to provide informed consent.</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n Willing and able to return to the clinic twice to three times a day for study visits.</li>\n</ul>\n<p>\n  </p>\n<p>\n Step 2: Inclusion Criteria</p>\n<ul>\n <li>\n Completion of Step 1</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n Step 1: Exclusion Criteria</p>\n<ul>\n <li>\n Previous history or current use of ART.</li>\n <li>\n Single dose NVP or dual therapies used for PMTCT within 2 years prior to entry.</li>\n <li>\n Use of any medication with antimalarial activity, including TMP/SMX (see list of prohibited medications in the A5297 MOPS), within 14 days prior to study entry.</li>\n <li>\n Confirmed or clinically suspected OIs (including but not limited to tuberculosis, clinical malaria, <em>PCP</em>), or other pulmonary or gastrointestinal infections for which potential participants did not complete treatment more than 30 days prior to enrollment or have signs and symptoms during screening.</li>\n <li>\n Breastfeeding.</li>\n <li>\n Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.</li>\n <li>\n Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.</li>\n <li>\n Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.</li>\n <li>\n Results suggestive of active pulmonary disease from a chest x-ray performed within 30 days prior to study entry.</li>\n</ul>\n<p>\n Step 2: Exclusion Criteria</p>\n<p>\n There are no exclusion criteria for Step 2</p>\n
      • primary_end_points<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\">The primary endpoint is PCR defined clearance of <i>Pf </i>parasitemia defined as < 10 parasites/μL on three consecutive occasions within a 24-hour period. </span></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Dr. Victor Akelo<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">MBChB, MPH<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Principal Investigator and Study Medical Officer<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">HIVR Research Branch<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">KEMRI/CDC, (Kisumu)<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Will oversee daily study operations and implementation.  Will supervise Kisumu-based study staff.  Substantial input into site-specific study design, protocol development and assessment tools.  Will guide study implementation, data analysis and report writing.  Will be a member of the protocol team.</span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n  </p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Frank Angira<o:p></o:p></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">DCM, ADPH, MPH (c)<o:p></o:p></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Co-Principal Investigator and Study Coordinator<o:p></o:p></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">KEMRI/CDC (Kisumu)<o:p></o:p></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Will provide input for data analysis and will write report. Will be a member of the protocol team with substantial input into site-specific study design, protocol development and assessment tools.  Will assist with study implementation, data analysis and report writing. Will coordinate all field components of the study, will interact daily with the study participants, study team and investigators.<o:p></o:p></span></p>\n<p>\n  </p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Clement Zeh<o:p></o:p></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">MPH, PhD<o:p></o:p></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Co-Principal Investigator<o:p></o:p></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">KEMRI/CDC (Kisumu)<o:p></o:p></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Will provide input for data analysis and will write report. Will oversee all laboratory aspects of the study. Will be a member of the protocol team with substantial input into site-specific study design, protocol development and assessment tools.  Will assist with study implementation and report writing.<o:p></o:p></span></span></p>\n<p>\n  </p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span style=\"color: black; font-family:;\">Kevin Cain </span><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><o:p></o:p></span></span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span style=\"color: black; font-family:;\">MD</span><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><o:p></o:p></span></span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Co-Investigator<o:p></o:p></span></span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">The Kisumu CRS leader. Will provide substantial input into the site-specific study design, protocol development and assessment tools. Will assist with study implementation, data analysis and report writing.  </span></span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><o:p></o:p></span> </span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Aaron Samwels<o:p></o:p></span></span></span></font></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">MD, MHS<o:p></o:p></span></span></span></font></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Co-investigator<o:p></o:p></span></span></span></font></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Will provide substantial input into site-specific study design, protocol development and assessment tools. Will assist with study implementation, data analysis and report writing<o:p></o:p></span></span></span></font></p>\n<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"> </span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"> </span></font></span></span></p>\n<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"> </font></span></span></p>\n<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"> </span></span></p>\n<p>\n <span style=\"font-size: 12px;\"> </span></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\">The study sponsors are based in the united states.The study aims to enrol participants with parasitemia and also infected with HIV, such population is not readily available in the sponsor country. The study is thus restricted to limited resource setting, and the implementing countries are thus considered as such. <span style="line-height: 115%; mso-ansi-language: EN-US; mso-ascii-theme-font: minor-latin;" minor-fareast;="" minor-latin;="" "times="" roman";="" minor-bidi;="" en-us;="" ar-sa;"="" new="" times=""><font color=\"#000000\">As at 24^th November 2014, the study had enrolled a total of 9 participants out of the targeted 52 across all the participating clinical research sites (CRS)</font></span></span></p>\n<p>\n  </p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"691\">\n <tbody>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 20px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 20px;\">\n <p>\n <strong>City</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 132px; height: 20px;\">\n <p>\n <strong>Clinical Research Site </strong></p>\n </td>\n <td style=\"width: 52px; height: 20px;\">\n <p>\n <strong>Site ID</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 176px; height: 20px;\">\n <p>\n <strong>Clinical trial Unit Name</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 20px;\">\n <p>\n <strong>Date Activated </strong></p>\n </td>\n <td style=\"width: 66px; height: 20px;\">\n <p>\n <strong>Number Enrolled </strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 40px;\">\n <p>\n Uganda</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 40px;\">\n <p>\n Kampala</p>\n </td>\n <td style=\"width: 132px; height: 40px;\">\n <p>\n Joint Clinical Research Centre /Kampala CRS</p>\n </td>\n <td style=\"width: 52px; height: 40px;\">\n <p>\n 12401</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 176px; height: 40px;\">\n <p>\n Case CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 40px;\">\n <p>\n 6^th May 2013</p>\n </td>\n <td style=\"width: 66px; height: 40px;\">\n <p>\n Zero (0)</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 63px;\">\n <p>\n Malawi</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 63px;\">\n <p>\n Lilongwe</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 132px; height: 63px;\">\n <p>\n Malawi CRS</p>\n </td>\n <td style=\"width: 52px; height: 63px;\">\n <p>\n 12001</p>\n </td>\n <td style=\"width: 176px; height: 63px;\">\n <p>\n University of North Carolina Global HIV prevention and treatment CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 63px;\">\n <p>\n 22^nd April 2013</p>\n </td>\n <td style=\"width: 66px; height: 63px;\">\n <p>\n Zero (0)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 67px; height: 40px;\">\n <p>\n Kenya</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 40px;\">\n <p>\n Kericho</p>\n </td>\n <td style=\"width: 132px; height: 40px;\">\n <p>\n KEMRI/WRP CRS</p>\n </td>\n <td style=\"width: 52px; height: 40px;\">\n <p>\n 12501</p>\n </td>\n <td style=\"width: 176px; height: 40px;\">\n <p>\n United States Military HIV Research Program CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 40px;\">\n <p>\n 26^th June 2013</p>\n </td>\n <td style=\"width: 66px; height: 40px;\">\n <p>\n Nine (9)</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 40px;\">\n <p>\n Kenya</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 40px;\">\n <p>\n Eldoret</p>\n </td>\n <td style=\"width: 132px; height: 40px;\">\n <p>\n Moi University CRS</p>\n </td>\n <td style=\"width: 52px; height: 40px;\">\n <p>\n 12601</p>\n </td>\n <td style=\"width: 176px; height: 40px;\">\n <p>\n United States Military HIV Research Program CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 40px;\">\n <p>\n 22^nd October 2013</p>\n </td>\n <td style=\"width: 66px; height: 40px;\">\n <p>\n Zero (0)</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 60px;\">\n <p>\n Kenya</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 60px;\">\n <p>\n Kisumu</p>\n </td>\n <td style=\"width: 132px; height: 60px;\">\n <p>\n KEMRI/CDC CRS</p>\n </td>\n <td style=\"width: 52px; height: 60px;\">\n <p>\n 31460</p>\n </td>\n <td style=\"width: 176px; height: 60px;\">\n <p>\n Emory-CDC CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 60px;\">\n <p>\n Not yet activated</p>\n </td>\n <td style=\"width: 66px; height: 60px;\">\n <p>\n N/A</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 40px;\">\n <p>\n Malawi</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 40px;\">\n <p>\n Blantyre</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 132px; height: 40px;\">\n <p>\n Blantyre CRS</p>\n </td>\n <td style=\"width: 52px; height: 40px;\">\n <p>\n 30301</p>\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 176px; height: 40px;\">\n <p>\n The John Hopkins University-Blantyre CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 40px;\">\n <p>\n Not yet activated</p>\n </td>\n <td style=\"width: 66px; height: 40px;\">\n <p>\n N/A</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 44px;\">\n <p>\n India</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 44px;\">\n <p>\n Chennai</p>\n </td>\n <td style=\"width: 132px; height: 44px;\">\n <p>\n Chennai Antiviral research and treatment CRS</p>\n </td>\n <td style=\"width: 52px; height: 44px;\">\n <p>\n 11701</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 176px; height: 44px;\">\n <p>\n University of California CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 44px;\">\n <p>\n Not yet activated</p>\n </td>\n <td style=\"width: 66px; height: 44px;\">\n <p>\n N/A</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SSC</p>\n<p>\n KEMRI ERC</p>\n<p>\n CDC IRB (with reliance on KEMRI)</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_duration30days
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorLopinavir/Ritonavir regim
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/CDC CLINICAL RESEARCH CENTRE
      • single_site_physical_addressWITHING JARAMOGI OGINGA ODINGA TEACHING & REFERRAL HOSPITAL
      • single_site_contact_personDr. Kevin Cain
      • single_site_telephone+254-57-2022929
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listUganda, Malawi, Kenya, India
      • data_monitoring_committeeYes
      • total_enrolment_per_site25-30
      • total_participants_worldwide52
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJohnstone
      • investigator1_middle_name
      • investigator1_family_nameKumwenda
      • investigator1_qualificationMD
      • investigator1_professional_addressCollege of Medicine-Johns Hopkins Project Chipatala Avenue
      • investigator1_telephone265-187-0132 x 307
      • investigator1_emailjkumwenda@jhu.medcol.mw
      • organisations_transferred_No
      • number_participants25-30
      • notification
      • approval_date02-02-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-12-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-02-28 14:21:21
      • created2014-11-25 13:47:01
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id246
        • application_id351
        • given_nameVICTOR
        • middle_name
        • family_nameAKELO
        • qualificationMSc. Public Health, MBA(cont.), MBChB
        • professional_addressPO BOX 1578 - 40100, KEMRI/CDC, KISUMU
        • telephone057 2022902/59/02
        • emailvakelo@kemricdc.org
        • created2014-11-25 13:59:56
        • modified2014-12-03 15:39:08
    • SiteDetail(array)
      • 0(array)
        • id297
        • application_id351
        • county_id42
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-11-25 13:59:56
        • modified2014-12-03 15:39:08
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id186
        • application_id351
        • sponsorNational Institute of Allergy and Infectious Diseases (DAIDS)
        • sponsor_type(null)
        • contact_personEileen Pouliot
        • address6700-B Rockledge Drive Room 3214, MSC 7612 Bethesda, Maryland 20892-7612
        • telephone_number+1-240-499-2239
        • fax_number
        • cell_number+1-240-499-2239
        • email_addressNIAIDOCSO@niaid.nih.gov
        • created2014-11-25 13:59:56
        • modified2014-12-03 15:39:08
  • 3(array)
    • Application(array)
      • id346
      • user_id81
      • trial_status_id5
      • abstract_of_study<p>\n Previous Ebola outbreaks have been limited to individual countries and contained by infection control activities.  The current outbreak in West Africa is international, and air travel has resulted in a number of infected travellers crossing national borders.  Although Kenya has not previously experienced outbreaks of Ebola, we are now at particular risk because of Kenya’s role as a hub for international travel.  There are currently no specific treatments generally available for Ebola and the mortality is high, particularly in countries with limited intensive care facilities.  There is currently no vaccine and the personal protection required by healthcare workers treating patients is cumbersome and requires full compliance to be protective.<br />\n We are conducting this trial, a Phase I, open-label, dose escalation trial, designed to establish safety, tolerability and immunogenicity of two doses of VSVΔG-ZEBOV, an Ebola Virus Vaccine Candidate for the first time in sub-Saharan African populations.  There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon, Switzerland and Germany), WHO and New Link Genetics (the vaccine manufacturer) under which this study will be conducted.<br />\n We plan to vaccinate 40 volunteers in Kenya.  The trial will be conducted at the KEMRI-CGMR Coast site where healthcare workers (both clinical and laboratory) will be the primary target population as they are likely to be the recipients of a protective vaccine.  We will vaccinate a cohort of 20 volunteers at a low dose and then vaccinate a further cohort of 20 volunteers at full dose. Each volunteer will receive one dose of the vaccine.  We will follow them up for a period of one year looking to their safety and immunogenicity endpoints.</p>\n
      • study_title<address>\n <address>\n <strong>A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Kilifi, Kenya.</strong></address>\n</address>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • laymans_summary<address>\n <strong><u> A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Kilifi, Kenya.</u></strong></address>\n<address>\n <strong><u>Lay title: A study to find out if a new Ebola vaccine is safe and may protect adults.</u></strong></address>\n<address>\n <strong>What is the problem/background?</strong></address>\n<address>\n Ebola is a disease that occurs in epidemics. So far it occurs in outbreaks and more than half of the affected people die from the disease. Currently there is an outbreak in West and Central Africa that has affected over 7,000 people with over 3,000 deaths. There is no treatment or vaccine for Ebola. The therapies available currently are still in development and have not been licenced for use in humans. The World Health Organisation together with the vaccine manufacturer have asked a few research centres to be involved in the testing of this vaccine of which we are one centre.</address>\n<address>\n <strong>What questions are we trying to answer?</strong></address>\n<address>\n Is this Ebola vaccine safe to give in adults in Kilifi? Does this Ebola vaccine lead to an immune response in adults in Kilifi?</address>\n<address>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></address>\n<address>\n The study will be carried out at the KEMRI –CGMR Coast in Kilifi. We aim to enroll 40 adults (health workers) in this study. They will be volunteers following dissemination talks and those interested will be invited to get further information on the study. They will then make a decision to be included in the study.</address>\n<address>\n <strong>What does the study involve for those who are in it?</strong></address>\n<address>\n The volunteers will sign the informed consent to indicate their willingness to be involved in the study. They will undergo a clinical examination and tests to ensure that they are healthy. They will receive one dose of the vaccine and then have 10 follow-up visits over 1 year.  </address>\n<address>\n <strong>What are the benefits and risks/costs of the study for those involved?  </strong></address>\n<address>\n The benefits will be thorough clinical tests which might identify problems not previously identified. There will be some risks from the procedures such as pain and discomfort. There may be a reaction to the vaccine such as fever, pain or general malaise. There may be rare and unexpected risks such as an allergic reaction.</address>\n<address>\n <strong>How will the study benefit society?  </strong></address>\n<address>\n Should this study prove the vaccine to be safe and show an immune response, it may provide the basis for use in outbreak situation. </address>\n<address>\n <strong>When does the study start and finish?  </strong></address>\n<address>\n The study will run for 1 year<strong>. </strong></address>\n<p>\n <br />\n <br />\n  </p>\n
      • short_titleZEBOV Trial
      • protocol_noECCT/14/11/01
      • version_noVersion 1.4 dated 30 October 2014
      • date_of_protocol30-10-2014
      • study_drugBPSC1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate
      • disease_conditionEbola haemorrhagic fever or Ebola virus disease
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantPhilip Bejon
      • declaration_date120-11-2014
      • declaration_principal_investigatorPatricia Njuguna
      • declaration_date220-11-2014
      • placebo_presentNo
      • study_objectives<address>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\"><em>To evaluate VSV vaccine viraemia using PCR after administration of VSVG-ZEBOV vaccine<strong>.</strong></em></span></span></address>\n<address>\n <address>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\"><em>To evaluate the ZEBOV-specific antibody responses induced by VSVΔG-ZEBOV vaccine<strong>.</strong></em></span></span></address>\n <address>\n <address>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\"><em>To evaluate VSV vaccine viraemia using PCR after administration of VSVG-ZEBOV vaccine<strong>.</strong></em></span></span></address>\n </address>\n</address>\n
      • principal_inclusion_criteria<p>\n • Have provided written informed consent prior to screening procedures (i.e. participants must be literate).<br />\n • Healthy adult male or non-pregnant, non-lactating female, ages 18 to 55 (inclusive) at the time of screening<br />\n • Free of clinically significant health problems, as determined by pertinent medical history, clinical examination and blood tests at screening<br />\n • Available, able, and willing to participate for all study visits and procedures<br />\n • Negative pregnancy-test for female volunteers<br />\n • Females, of non-childbearing potential who are post-menopausal (i.e. ≥ one year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)<br />\n • Females, of childbearing potential, who are willing to use effective methods of contraception for 14 days before vaccination and 30 days after vaccination.<br />\n • Males who are willing to use effective contraception following vaccination for a period of one week.<br />\n • Be willing to minimize blood and body fluid exposure of others for 5 days after vaccination<br />\n �</p>\n
      • principal_exclusion_criteria<p>\n • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.<br />\n • Known allergy to the components of the BPSC1001 vaccine product<br />\n • Unable or unwilling to stay in the study area for the period of the study and comply with study procedures.<br />\n • Ongoing participation in another clinical trial<br />\n • Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines)<br />\n • Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test<br />\n • Any serologic evidence of hepatitis B SAg or HIV infection.<br />\n • Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes<br />\n • Have an active malignancy or history of metastatic or hematologic malignancy<br />\n • Suspected or known alcohol and/or illicit drug abuse within the past 5 years<br />\n • Moderate or severe illness and/or fever >38°C within 2 weeks prior to vaccination<br />\n • Pregnant or lactating woman or a woman who intends to become pregnant within 30 days following vaccination.<br />\n • Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period<br />\n • Administration of chronic (defined as more than 14 days) immunosuppressant’s or other immune modifying drugs within 6 months of study entry<br />\n • Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study</p>\n<p>\n �</p>\n
      • primary_end_points<p>\n 1. The incidence of adverse events (AEs) and/or serious adverse events (SAEs) causally inked to the study intervention in the first 14 and 30 days respectively.</p>\n<p>\n 2. The titres of� ZEBOV-specific IgG antibodies.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 1, Dose escalation
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" height=\"167\" width=\"628\">\n <colgroup>\n <col />\n <col />\n <col />\n <col />\n <col />\n </colgroup>\n <tbody>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;width:111px;\">\n Staff role�</td>\n <td style=\"width:83px;\">\n Number�</td>\n <td style=\"width:131px;\">\n Name�</td>\n <td style=\"width:131px;\">\n Qualifications�</td>\n <td style=\"width:144px;\">\n Years of Experience�</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n PI</td>\n <td>\n 1</td>\n <td>\n Philip Bejon</td>\n <td>\n PhD / MBBS</td>\n <td>\n 15</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Co-PI / Co-ordinator</td>\n <td>\n 1</td>\n <td>\n Patricia Njuguna�</td>\n <td>\n MMed</td>\n <td>\n 10</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Nurse�</td>\n <td>\n 1</td>\n <td>\n Anderson Kahindi</td>\n <td>\n KRN</td>\n <td>\n 20</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Medical officer</td>\n <td>\n 1</td>\n <td>\n Caroline Ogwang</td>\n <td>\n MBCHB</td>\n <td>\n 6</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Pharmacist�</td>\n <td>\n 1</td>\n <td>\n Jimmy Shangalla</td>\n <td>\n Mpharm</td>\n <td>\n 10</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Data entry clerk</td>\n <td>\n 1</td>\n <td>\n TBA</td>\n <td>\n Diploma�</td>\n <td>\n 8</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Lab technician�</td>\n <td>\n 1</td>\n <td>\n TBA</td>\n <td>\n Diploma�</td>\n <td>\n 8</td>\n </tr>\n </tbody>\n</table>\n<p>\n �</p>\n
      • other_details_explanation<p>\n The trial is to be conducted in Kenya as the centre is known to be a leading site in conducting clinical trials in Africa. We have the clinical and laboratory capacity to run GCP standard trials. The sponsor is an affiliate of the KEMRI Wellcome Trust Research Programme while the Principal investigator holds a contract with the University of Oxford (the sponsor).</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Not applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_durationone year
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Wellcome Trust Research Programme
      • single_site_physical_addressHospital Grounds off Bofa Road
      • single_site_contact_personDr Philip Bejon
      • single_site_telephone+254 41 7522063
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site40
      • total_participants_worldwide230
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailpnjuguna@kemri-wellcome.org
      • organisations_transferred_Yes
      • number_participants40
      • notification
      • approval_date08-12-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-08-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n BACKGROUND<br />\n The replication-competent recombinant vesicular stomatitis virus (rVSV)–based vaccine<br />\n expressing a Zaire ebolavirus (ZEBOV) glycoprotein was selected for rapid safety and immunogenicity<br />\n testing before its use in West Africa.<br />\n METHODS<br />\n We performed three open-label, dose-escalation phase 1 trials and one randomized,<br />\n double-blind, controlled phase 1 trial to assess the safety, side-effect profile, and immunogenicity<br />\n of rVSV-ZEBOV at various doses in 158 healthy adults in Europe and<br />\n Africa. All participants were injected with doses of vaccine ranging from 300,000 to<br />\n 50 million plaque-forming units (PFU) or placebo.<br />\n RESULTS<br />\n No serious vaccine-related adverse events were reported. Mild-to-moderate early-onset<br />\n reactogenicity was frequent but transient (median, 1 day). Fever was observed in up to<br />\n 30% of vaccinees. Vaccine viremia was detected within 3 days in 123 of the 130 participants<br />\n (95%) receiving 3 million PFU or more; rVSV was not detected in saliva or<br />\n urine. In the second week after injection, arthritis affecting one to four joints developed<br />\n in 11 of 51 participants (22%) in Geneva, with pain lasting a median of 8 days<br />\n (interquartile range, 4 to 87); 2 self-limited cases occurred in 60 participants (3%) in<br />\n Hamburg, Germany, and Kilifi, Kenya. The virus was identified in one synovial-fluid<br />\n aspirate and in skin vesicles of 2 other vaccinees, showing peripheral viral replication<br />\n in the second week after immunization. ZEBOV-glycoprotein–specific antibody responses<br />\n were detected in all the participants, with similar glycoprotein-binding antibody<br />\n titers but significantly higher neutralizing antibody titers at higher doses. Glycoprotein-<br />\n binding antibody titers were sustained through 180 days in all participants.<br />\n CONCLUSIONS<br />\n In these studies, rVSV-ZEBOV was reactogenic but immunogenic after a single dose and<br />\n warrants further evaluation for safety and efficacy. (Funded by the Wellcome Trust and<br />\n others; ClinicalTrials.gov numbers, NCT02283099, NCT02287480, and NCT02296983;<br />\n Pan African Clinical Trials Registry number, PACTR201411000919191.)</p>\n
      • implication_results
      • quantity_imported44
      • quantity_dispensed40
      • quantity_destroyed0
      • quantity_exported0
      • balance_site4
      • final_date0000-00-00
      • modified2021-08-13 10:58:45
      • created2014-11-03 13:50:59
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id239
        • application_id346
        • given_namePhilip
        • middle_name
        • family_nameBejon
        • qualificationPhD
        • professional_addressKEMRI Wellcome Trust Research Programme PO Box 230-80108 Kilifi Kenya
        • telephone+254724445743
        • emailPBejon@kemri-wellcome.org
        • created2014-11-04 10:20:06
        • modified2021-08-12 10:26:46
      • 1(array)
        • id240
        • application_id346
        • given_namePatricia
        • middle_name
        • family_nameNjuguna
        • qualificationMMed
        • professional_addressKEMRI Wellcome Trust Research Programme PO Box 230-80108 Kilifi Kenya
        • telephone+254721833063
        • emailPNjuguna@kemri-wellcome.org
        • created2014-11-04 10:33:18
        • modified2021-08-12 10:26:46
    • SiteDetail(array)
      • 0(array)
        • id291
        • application_id346
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-11-04 10:20:06
        • modified2021-08-12 10:26:46
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id183
        • application_id346
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personPhilip Bejon
        • addressKEMRI Wellcome Trust Research Programme, Hospital Grounds Off Bofa Road, PO Box 230 80108, Kilifi, Kenya
        • telephone_number+254 41 7522 063
        • fax_number+254 41 7522 390
        • cell_number+254724445743
        • email_addressPBejon@kemri-wellcome.org
        • created2014-11-04 10:20:06
        • modified2021-08-12 10:26:46
  • 4(array)
    • Application(array)
      • id325
      • user_id219
      • trial_status_id2
      • abstract_of_study<p>\n <strong>The problem</strong></p>\n<p>\n Worldwide, over 10 million people are killed or hospitalised because of traumatic brain injury (TBI) each year. Approximately 90% of deaths from TBI occur in low and middle income countries. TBI predominantly affects young adults and many patients experience long lasting or permanent disability. The social and economic burden of TBI is considerable. With rapidly increasing motorisation, the incidence of TBI is predicted to rise in low and middle income countries. An effective, widely practicable and affordable treatment for TBI could save many thousands of lives and could substantially reduce the burden of disability.</p>\n<p>\n <strong>The aim</strong></p>\n<p>\n The CRASH-3 trial will provide reliable evidence about the effect of tranexamic acid on mortality and disability in patients with TBI. The effect of TXA on the risk of vascular occlusive events and seizures will also be assessed.</p>\n<p>\n <strong>The intervention</strong></p>\n<p>\n Systemic antifibrinolytic drugs, including tranexamic acid, are widely used in surgery to prevent clot breakdown (fibrinolysis) and thus reduce surgical blood loss.  Currently there is insufficient reliable evidence to assess the effectiveness of tranexamic acid traumatic brain injury.  This trial would provide a reliable basis for recommending whether or not tranexamic acid should be administered to patients with TBI.</p>\n<p>\n <strong>The trial</strong></p>\n<p>\n The CRASH-3 trial is a large, international, randomised, placebo controlled trial, to quantify the safety and effect on mortality and morbidity of the administration of tranexamic acid in patients with TBI. Adults with TBI, who are within eight hours of injury, with any intracranial bleeding on CT scan or who have a GCS of 12 or less, and have no significant extra-cranial haemorrhage, are eligible for inclusion, except those for whom antifibrinolytic agents are thought to be clearly indicated or clearly contra-indicated.  Treatment will be allocated randomly and numbered drug /placebo packs will be available in participating hospitals. The primary outcome will be death in hospital within 28 days of injury (cause of death will be described). Outcomes will be assessed at death, discharge or 28 days after randomisation, whichever occurs first.</p>\n
      • study_title<p>\n Acronymn: CRASH-3</p>\n<p>\n Short Title: Clinical Randomisation of an Antifibrinolytic in Significant Head Injury</p>\n<p>\n Full Title: Tranexamic acid for the treatment of significant traumatic brain injury: an international randomised, double blind placebo controlled trial</p>\n<p>\n ISRCTN15088122</p>\n<p>\n ClinicalTrials.gov ID: NCT01402882 </p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/14/10/02
      • version_nov1.0
      • date_of_protocol01-10-2011
      • study_drugTranexamic acid (TXA)
      • disease_conditionTraumatic brain injury
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameTranexamic acid (TXA)
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresscrash.mail@lshtm.ac.uk
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantMs Haleema Shakur
      • declaration_date120-10-2014
      • declaration_principal_investigatorDr Vincent Mutiso
      • declaration_date220-10-2014
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<div>\n Adults (believed to be 18 years or older) with traumatic brain injury:</div>\n<div>\n ï‚·- who are within eight hours of injury</div>\n<div>\n ï‚·- with any intracranial bleeding on CT scan or who have a GCS of 12 or less, and</div>\n<div>\n ï‚·- who have no significant extra cranial bleeding (needing immediate blood transfusion)</div>\n<div>\n ï‚·- the randomising clinician is suitably uncertain as to the appropriateness of tranexamic acid for the patient</div>\n
      • principal_exclusion_criteria<p>\n - Patients should not be randomised if the responsible clinician considers there is a clear indication for antifibrinolytic therapy</p>\n<p>\n - Patients should not be randomised if the responsible clinician considers there is a clear contraindication for antifibrinolytic therapy</p>\n
      • primary_end_points<p>\n Discharge, death or day 28 (whichever is earlier).</p>\n<p>\n <strong>Primary outcome: </strong></p>\n<p>\n The primary outcome is death in hospital within 28 days of injury (cause-specific mortality will also be recorded).</p>\n<div>\n <strong>Secondary outcomes:</strong></div>\n<div>\n  </div>\n<div>\n (a) Vascular occlusive events (myocardial infarction, pulmonary embolism, clinical evidence of deep vein</div>\n<div>\n thrombosis)</div>\n<div>\n (b) Stroke</div>\n<div>\n (c) Disability assessed using the Disability Rating Scale and Patient Orientated Outcome measures</div>\n<div>\n (d) Seizures</div>\n<div>\n (e) Neurosurgical intervention</div>\n<div>\n (f) Days in intensive care</div>\n<div>\n (g) Other adverse events</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n These sites have been assessed by the sponsor as suitable to carry out the study based on the following key information<em>:</em></p>\n<p style=\"margin-left:72.0pt;\">\n o    The Principal Investigator is a registered, qualified medical doctor;</p>\n<p style=\"margin-left:72.0pt;\">\n o    The site cares for a reasonable number of patients with traumatic brain injury;</p>\n<p style=\"margin-left:72.0pt;\">\n o    The Principal Investigator has completed Good Clinical Practice (GCP) training;</p>\n<p style=\"margin-left:72.0pt;\">\n o    Other trial team members have/are willing to complete GCP training;</p>\n<p style=\"margin-left:72.0pt;\">\n o    The site provides the minimum level of emergency WHO services;</p>\n<p style=\"margin-left:72.0pt;\">\n o    The Principal Investigator has put together a trial team at their site and takes responsibility for the trial team and the care of the patients in the trial;</p>\n<p style=\"margin-left:72.0pt;\">\n o    Additional responsibilities of the sites and Investigators are detailed in the Protocol and Principal Investigator Agreement (which is signed by the Principal Investigator and site);</p>\n<p style=\"margin-left:72.0pt;\">\n o    The hospital’s ethics committee has given approval for the trial to be conducted.</p>\n<p>\n Please see attached CVs for trial team members experience.</p>\n<p>\n <strong><u>Kenyatta National Hospital</u></strong></p>\n<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n Name</td>\n <td>\n Qualification</td>\n <td>\n Job Title</td>\n <td>\n Role in Trial</td>\n </tr>\n <tr>\n <td>\n Dr Julius Githinji Kiboi</td>\n <td>\n MMed Surgery</td>\n <td>\n Senior Lecturer and Neurosurgeon</td>\n <td>\n Principal Investigator</td>\n </tr>\n <tr>\n <td>\n Dr Vincent Mutiso</td>\n <td>\n MBChB, MMed (Surgery), FCS (ecsa)</td>\n <td>\n Senior Lecturer in Orthopaedic Surgery Dept/Orthopaedic and Trauma Surgeon</td>\n <td>\n National Coordinator in Kenya, sub-investigator at KNH</td>\n </tr>\n <tr>\n <td>\n Dr Peter Kithikii Kitunguu</td>\n <td>\n MMed (Neurosurgery), MBChB</td>\n <td>\n Tutorial Fellow in Neurosurgery</td>\n <td>\n Data collector</td>\n </tr>\n <tr>\n <td>\n Dr Nilesh Kumar Mohan</td>\n <td>\n MMed (Neurosurgery), MBChB</td>\n <td>\n Resident in Neurosurgery</td>\n <td>\n Sub-investigator</td>\n </tr>\n <tr>\n <td>\n Dr Solomon Wahome Murithi</td>\n <td>\n MBChB</td>\n <td>\n Medical Officer</td>\n <td>\n Sub-investigator</td>\n </tr>\n </tbody>\n</table>\n<p>\n <strong><u>Kitui District Hospital</u></strong></p>\n<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n Name</td>\n <td>\n Qualification</td>\n <td>\n Job Title</td>\n <td>\n Role in Trial</td>\n </tr>\n <tr>\n <td>\n Dr Michael Dullo</td>\n <td>\n MBChB, MMed</td>\n <td>\n Surgeon</td>\n <td>\n Principal Investigator</td>\n </tr>\n <tr>\n <td>\n Dr Maureen Moraa Mabiria</td>\n <td>\n MBChB</td>\n <td>\n Medical Officer</td>\n <td>\n Sub-investigator, data collector</td>\n </tr>\n <tr>\n <td>\n Dr Burhanuddin Mustansir Nanabhai</td>\n <td>\n MBChB</td>\n <td>\n Medical Officer</td>\n <td>\n Sub-investigator, data collector</td>\n </tr>\n <tr>\n <td>\n Dr Salwa Mohammed Omar</td>\n <td>\n MBChB</td>\n <td>\n Medical Officer</td>\n <td>\n Data collector</td>\n </tr>\n <tr>\n <td>\n Dr Juliet Akoth Ooko</td>\n <td>\n MBChB</td>\n <td>\n Medical Officer</td>\n <td>\n Data collector</td>\n </tr>\n <tr>\n <td>\n Dr Grace Rabut</td>\n <td>\n MBChB</td>\n <td>\n Registered Medical Officer</td>\n <td>\n Data collector</td>\n </tr>\n </tbody>\n</table>\n<p>\n <strong><u>The Nairobi Hospital</u></strong></p>\n<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n Name </td>\n <td>\n Qualifications</td>\n <td>\n Job Title</td>\n <td>\n Role in Trial</td>\n </tr>\n <tr>\n <td>\n Dr Lallet Tasneem Essaji</td>\n <td>\n MD</td>\n <td>\n Clinical Medical Officer 2</td>\n <td>\n Principal Investigator</td>\n </tr>\n <tr>\n <td>\n Professor E Amayo</td>\n <td>\n MBChB, MMed</td>\n <td>\n Consultant Neurologist</td>\n <td>\n Sub-investigator</td>\n </tr>\n <tr>\n <td>\n Dr Lee Owuoth Ogutha</td>\n <td>\n MMed Neurosurgery, MBChB, AB (Genetics)</td>\n <td>\n Medical Officer</td>\n <td>\n Sub-investigator</td>\n </tr>\n <tr>\n <td>\n Dr David Oluoch - Olunya</td>\n <td>\n MBChB, FRCSEd, FRCS</td>\n <td>\n Consultant Neurosurgeon</td>\n <td>\n Sub-investigator</td>\n </tr>\n <tr>\n <td>\n Dr Odhiambo Ombewa</td>\n <td>\n MBChB</td>\n <td>\n Medical Officer</td>\n <td>\n Sub-investigator</td>\n </tr>\n <tr>\n <td>\n Dr Sydney Kirui Kipkorir Rono</td>\n <td>\n MBChB</td>\n <td>\n Resident and Medical Officer, Neurosurgery</td>\n <td>\n Sub-investigator</td>\n </tr>\n <tr>\n <td>\n Dr Zachariah Mark Shaka</td>\n <td>\n MBChB</td>\n <td>\n Medical Doctor</td>\n <td>\n Sub-investigator</td>\n </tr>\n <tr>\n <td>\n Ernest Clifford O Yogo</td>\n <td>\n KRN</td>\n <td>\n Nurse</td>\n <td>\n Data collector</td>\n </tr>\n <tr>\n <td>\n Rose Nduta Murakaru</td>\n <td>\n KRN/M, Diploma in Nursing, Diploma in Midwifery</td>\n <td>\n Senior Nurse / Midwife</td>\n <td>\n Data collector</td>\n </tr>\n <tr>\n <td>\n Ruth Kinyanjui</td>\n <td>\n Diploma in Health Records & Information Technology</td>\n <td>\n Medical Records Officer III</td>\n <td>\n Data collector</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A - The trial is to be conducted in countries worldwide, including the host country of the Sponsor.</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n <span style=\"font-family: Arial, sans-serif; line-height: 12.8400001525879px;\">Name of Regulatory Authority</span></td>\n <td>\n Country</td>\n <td>\n Date of application submission</td>\n </tr>\n <tr>\n <td>\n Drug Controller General of India (DCGI)</td>\n <td>\n India</td>\n <td>\n 24/06/2013</td>\n </tr>\n <tr>\n <td>\n Pharmaceutical Regulatory Authority</td>\n <td>\n Zambia</td>\n <td>\n 13/08/2013</td>\n </tr>\n <tr>\n <td>\n Drug Regulatory Authority of Pakistan (DRA)</td>\n <td>\n Pakistan</td>\n <td>\n 16/11/2013</td>\n </tr>\n <tr>\n <td>\n Federal Agency for Medicines and Health Products (FAMHP)</td>\n <td>\n Belgium</td>\n <td>\n 25/09/2014</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n <span style=\"font-size: 9pt; line-height: 107%; font-family: Arial, sans-serif;\">Name of Regulatory Authority</span></td>\n <td>\n Country</td>\n <td>\n <span style=\"font-size: 9pt; line-height: 107%; font-family: Arial, sans-serif;\">Date of approval</span></td>\n <td>\n <span style=\"font-size: 9pt; line-height: 107%; font-family: Arial, sans-serif;\">Number of sites approved to date</span></td>\n </tr>\n <tr>\n <td>\n <span style=\"font-size: 9pt; line-height: 107%; font-family: Arial, sans-serif;\">Medicines and Healthcare products Regulatory Agency (MHRA)</span></td>\n <td>\n United Kingdom</td>\n <td>\n 08/08/2012</td>\n <td>\n 58</td>\n </tr>\n <tr>\n <td>\n Agencia Espanola de Medicamentos y Productos Santitarios (AEMPS)</td>\n <td>\n Spain</td>\n <td>\n 03/12/2012</td>\n <td>\n 8</td>\n </tr>\n <tr>\n <td>\n Registration and Drug Control Department</td>\n <td>\n United Arab Emirates</td>\n <td>\n 03/01/2013</td>\n <td>\n 1</td>\n </tr>\n <tr>\n <td>\n Biro Pengawalan Farmaseutikal Kebangsaan (BPFK)</td>\n <td>\n Malaysia</td>\n <td>\n 23/01/2013</td>\n <td>\n 11</td>\n </tr>\n <tr>\n <td>\n Comision Federal  para la Proteccion contra Riesgos Sanitarios (COFEPRIS)</td>\n <td>\n Mexico</td>\n <td>\n 06/02/2013</td>\n <td>\n 9</td>\n </tr>\n <tr>\n <td>\n National Agency for Food and Drug Adminisration and Control (NAFDAC)</td>\n <td>\n Nigeria</td>\n <td>\n 04/04/2013</td>\n <td>\n 9</td>\n </tr>\n <tr>\n <td>\n State Regulation Agency for Medical Activities (LEPL)</td>\n <td>\n Georgia</td>\n <td>\n 11/04/2013</td>\n <td>\n 4</td>\n </tr>\n <tr>\n <td>\n Pharmaceutical Directorate of the Ministry of Health</td>\n <td>\n Albania</td>\n <td>\n 20/06/2013</td>\n <td>\n 1</td>\n </tr>\n <tr>\n <td>\n Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)</td>\n <td>\n Colombia</td>\n <td>\n 16/07/2013</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n Ministry of Public Health</td>\n <td>\n Cameroon</td>\n <td>\n 21/08/2013</td>\n <td>\n 4</td>\n </tr>\n <tr>\n <td>\n Health Canada</td>\n <td>\n Canada</td>\n <td>\n 27/01/2014</td>\n <td>\n 7</td>\n </tr>\n <tr>\n <td>\n Agenzia Italiana del Farmaco (AIFA)</td>\n <td>\n Italy</td>\n <td>\n 11/04/2014</td>\n <td>\n 6</td>\n </tr>\n <tr>\n <td>\n <span style=\"font-size: 11.8181819915771px;\">National Agency for Medicines and Medical Devices</span></td>\n <td>\n Romania</td>\n <td>\n 03/10/2014</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n <span style=\"font-size: 11.8181819915771px;\">Department of Drug Administration</span></td>\n <td>\n Nepal</td>\n <td>\n 05/09/2014</td>\n <td>\n 6</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationStart date 01/12/2011, planned date of last recruitment 31/12/2016
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_statesN/A - please see answer to question 4.
      • number_of_sitesN/A - please see answer to question 4.
      • multi_country_listTo date (20/10/2014), 2494 patients have been randomised into the CRASH-3 trial at 86 sites in 15 countries worldwide:\nAfghanistan\nAlbania\nCameroon\nColombia\nEl Salvador\nGeorgia\nItaly\nJamaica\nJapan\nMalaysia\nMexico\nNigeria\nSpain\nUnited Arab Emirates\nUnited Kingdom\n\nOther countries where applications have been submitted include: Canada, Indonesia, Nepal, Pakistan, Peru, Romania, Tanzania, Tunisia, Uganda, Zambia
      • data_monitoring_committeeYes
      • total_enrolment_per_siteThere will be no minimum or maximum number of patients to be enrolled at each site. \nWe would like to bring to the attention of the PPB that the CRASH-3 Trial is a multi-centre, international trial planned to last two more years. There is no limit to the number of hospitals that can join the trial and we expect that after clearance is given by the PPB, other hospitals in Kenya will join the collaboration. Hospitals will only be allowed to take part in the trial once they have obtained PPB, Kenyatta National Hospital/University of Nairobi Ethics and Research Committee (KNH/UoN-ERC) and the relevant institutional approvals. The number of patients to be enrolled at each site will be dependent on the sites patient profile.
      • total_participants_worldwide10,000
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyThe Glasgow Coma Score (GCS) is a method of assessing the level of consciousness in TBI patients. Patients with a GCS score of 15 are generally considered fully conscious, but those with a GCS score of 12 or less are not fully conscious and would not be mentally capable of giving informed consent to participation in a clinical trial. Intracranial bleeding is a clinical sign indicating significant brain injury and patients with this diagnosis would not be physically or mentally capable of giving informed consent to participation in a clinical trial. Therefore, given that patients are eligible for inclusion in the CRASH-3 trial if they have sustained a traumatic brain injury and have either intracranial bleeding on a CT scan or a GCS of 12 or less, they will, by default, be physically or mentally incapable of giving consent.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVincent
      • investigator1_middle_name
      • investigator1_family_nameMutiso
      • investigator1_qualificationMBChB, MMed (Surgery), FCS (ecsa)
      • investigator1_professional_addressDepartment of Orthopaedic Surgery, The Nairobi Hospital, New Doctors Plaza, Suite 209, Argwings Kodhek Road, Hurlingham, Nairobi, Kenya
      • investigator1_telephone+254 723 737 719 / +254 733 289 922 / +254 202 846 437 / +254 727 681 660
      • investigator1_emailmutisovm@yahoo.com
      • organisations_transferred_Yes
      • number_participantsApproximately 1000 patients.
      • notification
      • approval_date05-02-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-10-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-06-12 17:44:34
      • created2014-09-08 16:22:31
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id231
        • application_id325
        • given_nameKiboi
        • middle_nameGithinji
        • family_nameJulius
        • qualificationMMed (Surgery)
        • professional_addressKenyatta National Hospital: Department of Surgery, MP Shah Hospital, Shivachi Road, Dinesh Chandaria Doctors Plaza, 2nd Floor Room S3, PO Box 38373, Code 00623, Parklands, Westlands, Nairobi, Kenya
        • telephone+254 720 498 015 / +254 203 740 471
        • emailj_kiboi@yahoo.com
        • created2014-09-08 16:24:09
        • modified2014-10-20 17:02:14
      • 1(array)
        • id232
        • application_id325
        • given_nameDullo
        • middle_name
        • family_nameMichael
        • qualificationMBChB, MMed
        • professional_addressKitui District Hospital: Department of Surgery, PO Box 22 - 90200, Kitui, Kenya
        • telephone+254 720 829 196
        • emailmicdullo@yahoo.com
        • created2014-09-08 16:34:12
        • modified2014-10-20 17:02:14
      • 2(array)
        • id233
        • application_id325
        • given_nameLallet
        • middle_nameTasneem
        • family_nameEssaji
        • qualificationMD
        • professional_addressThe Nairobi Hospital: Accident and Emergency Department, PO Box 30026 - 00100, GPO Kenyatta Avenue, Nairobi, Kenya
        • telephone+254 737 935 506 / +254 718 158 670
        • emailtasneemnurdin@hotmail.com
        • created2014-09-08 16:34:12
        • modified2014-10-20 17:02:14
    • SiteDetail(array)
      • 0(array)
        • id281
        • application_id325
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressDepartment of Surgery, MP Shah Hospital, Shivachi Road, Dinesh Chandaria Doctors Plaza, 2nd Floor Room S3, PO Box 38373, Code 00623, Parklands, Westlands, Nairobi, Kenya
        • contact_detailsTel: +254 720 498 015, PO Box: 38373, Code 00623
        • contact_personDr Julius Githinji Kiboi
        • site_capacity(null)
        • misc(null)
        • created2014-09-08 16:24:09
        • modified2014-10-20 17:02:14
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id282
        • application_id325
        • county_id15
        • site_nameKitui District Hospital
        • physical_addressDepartment of Surgery, PO Box 22 - 90200, Kitui, Kenya
        • contact_detailsTel: +254 720 829 196, PO Box 22 - 90200
        • contact_personDr Michael Dullo
        • site_capacity(null)
        • misc(null)
        • created2014-09-08 16:49:25
        • modified2014-10-20 17:02:14
        • County(array)
          • id15
          • county_nameKitui
          • created2012-06-15 10:23:48
          • modified2012-06-15 10:23:48
      • 2(array)
        • id283
        • application_id325
        • county_id47
        • site_nameThe Nairobi Hospital
        • physical_addressAccident and Emergency Department, PO Box 30026 - 00100, GPO Kenyatta Avenue, Nairobi, Kenya
        • contact_detailsTel: +254 737 935 506, PO Box 30026 - 00100
        • contact_personDr Lallet Tasneem Essaji
        • site_capacity(null)
        • misc(null)
        • created2014-09-08 17:05:25
        • modified2014-10-20 17:02:14
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id179
        • application_id325
        • sponsorLondon School of Hygiene and Tropical Medicine (LSHTM)
        • sponsor_type(null)
        • contact_personMs Haleema Shakur
        • addressClinical Trials Unit, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, Room 180, Keppel Street, London WC1E 7HT, UK
        • telephone_number+44(0)20 7299 4684
        • fax_number+44(0)20 7299 4663
        • cell_number+44(0)20 7299 4684
        • email_addressCrash.Mail@lshtm.ac.uk
        • created2014-09-08 16:24:09
        • modified2014-10-20 17:02:14
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php