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• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
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  • 6In follow-up
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  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id405
      • user_id38
      • trial_status_id8
      • abstract_of_study<p style=\"margin-left:.5in;\">\n The proposed research project will evaluate the effects of zinc supplementation in children with sickle cell disease (SCD) in western Kenya. Zinc is a nutritionally essential trace element found in previous studies to reduce growth retardation and improve immune function, which may also result in decreased incidence of infectious diseases including malaria, pneumonia and diarrhea. SCD patients are known to be susceptible to zinc deficiency and appear to benefit from zinc supplementation. Despite these findings, SCD patients in Kenya have not benefited from zinc supplementation programmes? due to a lack of research and findings to inform policy in the East African-setting. Specifically, the proposed pilot research project will: investigate the influence of zinc supplementation on incidence of malaria infections in children with SCD; investigate the influence of zinc supplementation on incidence of bacterial infections (e.g. <em>S pneumoniae</em>, <em>H influenzae</em> and non-typhi <em>Salmonella </em>species) in children with SCD and investigate the influence of zinc supplementation on morbidity in children with SCD in western Kenya. We will conduct a 6 month randomized controlled pilot trial involving children with SCD aged 6 months to less than 13 years, being treated and followed up routinely at the KEMRI- site and other selected health facilities in Western Kenya for SCD. The children will be randomized into two arms, with the Intervention Group receiving the recommended Ministry of Health (MoH)/World Health Organization (WHO) standard care in addition to three times weekly zinc supplementation (10 mg) and the Control Group receiving standard MoH care alone over a six month period. At baseline, at 3 months and at 6 months, clinical and laboratory evaluations, including serum zinc levels, malaria blood slides, anthropometric measurements and other indicated laboratory tests will be conducted. In addition, HIV testing will be carried out during the study as an important confounder. The differences in incidence of morbidity and other secondary endpoints will be compared between the zinc group and the control group.  The results are expected to determine the scientific basis for a larger clinical trial to determine the need for the addition of zinc supplement to the management of sickle cell disease.  </p>\n
      • study_title<p>\n <strong>The effects of Zinc supplementation in children with sickle cell disease in Western Kenya: a pilot study.</strong></p>\n
      • laymans_summary(null)
      • short_titleZINC in Sickle cell study
      • protocol_noECCT/15/06/02
      • version_no0.4
      • date_of_protocol24-01-2015
      • study_drugZinc Supplement
      • disease_conditionSickle Cell Disease
      • 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_nameZincfant
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@usamru-k.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)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
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      • 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_applicantVictorine Owira
      • declaration_date108-06-2015
      • declaration_principal_investigatorDr Lucas Otieno Tina
      • declaration_date208-06-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Male or female infants and children ≥ 6 months and < 13 years of age with confirmed SCD. </p>\n
      • principal_exclusion_criteria<ul>\n <li style=\"margin-left: 1in;\">\n Profound clinical evidence of current immunosuppression or evidence of active AIDS defining illness i.e. WHO HIV clinical stage III/IV</li>\n <li style=\"margin-left: 1in;\">\n History of allergic reactions to zinc or any other ingredients in the supplement</li>\n <li style=\"margin-left: 1in;\">\n History of any neurologic disorders or seizures</li>\n <li style=\"margin-left: 1in;\">\n Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, as determined by physical examination or laboratory screening tests</li>\n <li style=\"margin-left: 1in;\">\n Hemoglobin ≤5.0 g/dL </li>\n <li style=\"margin-left: 1in;\">\n Total White Cell Count below normal range <4.5 x 10³/uL</li>\n <li style=\"margin-left: 1in;\">\n Use of any investigational or non-registered drugs or vaccines or planned use</li>\n <li style=\"margin-left: 1in;\">\n Simultaneous participation in any other clinical trial (would it be worth increasing the age range to ensure vaccination schedule does not impact or get impacted?)</li>\n</ul>\n
      • primary_end_points<p style=\"margin-left:1.0in;\">\n Measurement of levels of zinc levels at 3 time points i.e. screening, study mid point and study conclusion.  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • 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_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study has 3 investigators, 1 coordinator, 2 nurses and 2 clinical officers. The laboratories with capabilities of diagnosing Sickle cell disease in Western Kenya will be used.</p>\n
      • other_details_explanation<p>\n N/A</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 N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration6 months
      • 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_comparatorstandard of care
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaHealth Facilities in Western Kenya
      • single_site_physical_addressObama Children\'s Hospital, Located witning JOOTRH Kisumu-Kenya
      • single_site_contact_personDr Lucas Otieno
      • single_site_telephone+254720597654
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site40
      • total_participants_worldwide40
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • 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_consentYes
      • subjects_specifyThe study will be enrolling children from 6 months to 13 years old.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLucas
      • investigator1_middle_nameOtieno
      • investigator1_family_nameTina
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_address54, 40100 Kisumu-Kenya
      • investigator1_telephone+254720597654
      • investigator1_emailLucas.Tina@usamru-k.org
      • organisations_transferred_No
      • number_participants40
      • notification
      • approval_date17-08-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-06-2015
      • 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)
      • modified2018-01-24 13:27:15
      • created2015-06-15 14:38:48
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id277
        • application_id405
        • given_nameLucas
        • middle_nameOtieno
        • family_nameTina
        • qualificationMedical Doctor
        • professional_address54, 40100 Kisumu-Kenya
        • telephone+254720597654
        • emailLucas.Tina@usamru-k.org
        • created2015-06-15 14:45:54
        • modified2015-06-15 15:42:06
    • SiteDetail(array)
      • 0(array)
        • id330
        • application_id405
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-06-15 14:45:54
        • modified2015-06-15 15:42:06
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id214
        • application_id405
        • sponsorGLAXOSMITHKLINE
        • sponsor_type(null)
        • contact_person
        • address54-40100 Kisumu
        • telephone_numberTel:+254-02-6933200
        • fax_number
        • cell_numberTel:+254-02-6933200
        • email_addressTina.lucas@usamru-k.org
        • created2015-06-15 14:45:54
        • modified2015-06-15 15:42:06
  • 1(array)
    • Application(array)
      • id403
      • user_id287
      • trial_status_id1
      • abstract_of_study<p>\n <strong>Background</strong></p>\n<p>\n Recent studies raise concerns that resistance against commonly used ACTs for the treatment of malaria in African countries may be emerging. Residual parasitaemia after treatment was found to be common in Western Kenya and associated with increased gametocyte carriage, a higher transmission potential and  an increased risk on recurrent parasitaemia. Therefore, not only the extensive monitoring of clearance dynamics is important, but also 1. the development and evaluation of alternative treatments and 2. the development of fast, easy-to-perform and sensitive diagnostics, capable of following parasite survival during and after treatment.</p>\n<p>\n One of these alternative treatments could be the combination of pyronaridine and artesunate (Shin Poong Pharmaceuticals). A child-friendly granule formulation (Pyramax) was developed for patients from the age of 3 months between 5 and 20 kg and has been shown to be well-tolerated and efficacious for the treatment of uncomplicated malaria in a phase III multicenter trial. dB-PCR-NALFIA is suggested as a suitable molecular tool to follow-up patients after treatment, as it is fast, sensitive and can be done in semi-field conditions.</p>\n<p>\n <strong>Objectives</strong></p>\n<p>\n Our objectives are:</p>\n<p>\n 1. To determine the efficacy of pyronaridine-artesunate (PA) compared to artemether-lumefantrine (AL), for the treatment of uncomplicated <em>falciparum </em>malaria in Kenyan children (primary objective);</p>\n<p>\n 2. To determine parasite clearance time after treatment by PA, compared to AL;</p>\n<p>\n 3. To determine the duration of gametocyte carriage after treatment by PA, compared to AL;</p>\n<p>\n 4. To determine the rate of gametocyte transmission to mosquitos after treatment by PA, compared to AL;</p>\n<p>\n 5. To determine the accuracy of dB-PCR-NALFIA compared to microscopy and real-time PCR;</p>\n<p>\n 6. To determine treatment efficacy and predict treatment outcome by dB-PCR-NALFIA, compared to real-time PCR and microscopy;</p>\n<p>\n 7. To determine the safety of pyronaridine-artesunate for the treatment of uncomplicated falciparum malaria in Kenyan children compared to that of artemether-lumefantrine.</p>\n<p>\n  </p>\n<p>\n <strong>Methods</strong></p>\n<p>\n The main study concerns a single-blind, randomised controlled non-inferiority trial in Mbita, Western Kenya. Children aged 6 months (and ≥5 kg) to 12 years will be randomly allocated to receive either PA or AL, and will be followed for 42 days. Finger-prick blood will be collected on day 0, 1, 2, 3, 7, 14, 28, and 42. On day 7, for children aged ≥2 years and only when additional informed consent is obtained, a 3ml venous blood sample will be collected instead of a finger-prick to determine transmission potential (objective 4). It is planned to include 225 children per intervention group. With this sample size it is possible to evaluate non-inferiority of PA compared to AL with a margin of 7% (corresponding to the absolute difference between groups), a one-sided alpha of 0.05 and a power of 91%. In the primary analysis non-inferiority of the PA group regarding the PCR-corrected ACPR-rate at day-28 compared to the AL group will be tested.</p>\n
      • study_title<p>\n Pyronaridine-artesunate and artemether-lumefantrine for the treatment of paediatric uncomplicated <em>falciparum</em> malaria in Western Kenya</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/06/01
      • version_no6
      • date_of_protocol13-04-2015
      • study_drugPyronaridine-Artesunate (Pyramax)
      • disease_conditionMalaria
      • 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_namePyronaridine-Artesunate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressj.roth@kit.nl
      • 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_addendum0
      • 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_applicantJohanna Roth
      • declaration_date104-06-2015
      • declaration_principal_investigatorDr. Patrick Sawa
      • declaration_date204-06-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Children between 6 months and 12 years old, with a body weight of ≥5 kg;</li>\n <li>\n Living in the catchment area of the study (within a radius of ~10 km from St. Jude’s Clinic);</li>\n <li>\n Having microscopically confirmed <em>P. falciparum</em> mono-infection (asexual parasite density 1,000-200,000 µL^-1).</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Signs and symptoms of severe malaria (according to WHO criteria for severe malaria, (WHO 2012)) or any other severe illness necessitating parenteral treatment;</li>\n <li>\n Mixed <em>Plasmodium </em>infection;</li>\n <li>\n Clinically suspected (oedema, jaundice and/or ascites) or reported hepatic and/or renal impairment (any cause, as reported by parents/guardians and/or evident from medical history);</li>\n <li>\n Having anaemia  with an Hb <6 g/dL;</li>\n <li>\n Evidence of severe malnutrition (severe wasting: z-score weight for age <-3 and severe stunting: z-score height for age <-3 (WHO 2009b));</li>\n <li>\n Having received anti-malarial therapy in the previous two weeks;</li>\n <li>\n Known history of hypersensitivity, allergic or adverse reactions to artesunate, artemether-lumefantrine or other artemisinins;</li>\n <li>\n Participating in other anti-malarial drug intervention studies;</li>\n <li>\n Previous participation in the PAAL study, e.g. in the previous transmission season (each individual child can only take part in this study once);</li>\n <li>\n Not being available for follow-up.</li>\n</ul>\n
      • primary_end_points<p>\n The primary outcome is the PCR-corrected adequate clinical and parasitological response (ACPR) on day 28, as indicated by negative microscopy.</p>\n
      • scope_diagnosis1
      • 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 This is a research clinic that has carried out multiple clinical trials over the last 8 years.</p>\n<p>\n Run by a medical team consisting of 1 doctor, 1 nurse, 2 medical laboratory technologists, a radiographer and a pharmacy technologist, this is a comprehensive outpatient clinic designed to offer high quality medical care to Icipe scientists, support staff and their families as well as the local community.</p>\n<p>\n We have the capacity to manage any acute medical emergencies as required. In case the required care is beyond our capacity, the local District hospital is 2km away.</p>\n<p>\n The hospital is fully equipped and also has a capacity to offer observation ward capacity where necessary.</p>\n<p>\n For research activities such as the upcoming PA-AL Study, we engage an independent research team to carry out the study in coordination with the existing clinic team. For this study we will engage at the very least, a study coordinator, a study nurse, 2 laboratory technologists and field workers.</p>\n
      • other_details_explanation<p>\n Malaria non-endemic in host country.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KEMRI - Scientific and Ethics Review Unit (SERU). Approval granted on May 7th 2015. Single site.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration9 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorArtemether-Lumefantrine
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaSt. Judes Clinic, ICIPE
      • single_site_physical_addressP. O. Box 30, Mbita 40305, Kenya
      • single_site_contact_personDr. Patrick Sawa
      • single_site_telephone+254722369254
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site450
      • total_participants_worldwide450
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • 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_consentYes
      • subjects_specifyYoung children
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameHenk
      • investigator1_middle_name
      • investigator1_family_nameSchallig
      • investigator1_qualificationPhD
      • investigator1_professional_addressMeibergdreef 39, 1105AZ, Amsterdam
      • investigator1_telephone+31(0)205665447
      • investigator1_emailh.schallig@kit.nl
      • organisations_transferred_Yes
      • number_participants450
      • notification
      • approval_date04-09-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-06-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-09-20 10:48:05
      • created2015-06-04 10:26:17
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id276
        • application_id403
        • given_namePatrick
        • middle_name
        • family_nameSawa
        • qualificationDr.
        • professional_addressSt. Jude’s Clinic ICIPE, P. O. Box 30, Mbita 40305, Kenya
        • telephone+245722369254
        • emailpsawa@icipe.org
        • created2015-06-04 10:35:55
        • modified2015-06-05 16:22:04
    • SiteDetail(array)
      • 0(array)
        • id329
        • application_id403
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-06-04 10:35:55
        • modified2015-06-05 16:22:04
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id213
        • application_id403
        • sponsorRoyal Tropical Institute, KIT Biomedical Research
        • sponsor_type(null)
        • contact_personJ.M. Roth
        • addressMeibergdreef 39, 1105 AZ, Amsterdam, The Netherlands
        • telephone_number+31(0)205665442
        • fax_number
        • cell_number+31(0)613691166
        • email_addressj.roth@kit.nl
        • created2015-06-04 10:35:55
        • modified2015-06-05 16:22:04
  • 2(array)
    • Application(array)
      • id391
      • user_id271
      • trial_status_id6
      • abstract_of_study<p>\n The goal of this project is to evaluate the acceptability of three multipurpose prevention technology (MPT) delivery forms for prevention of HIV and unintended pregnancy among young women in Kenya and South Africa: a vaginal ring, an injectable, and a co-formulated daily oral tablet (all placebos).</p>\n<p>\n This research will integrate data collected through three primary activities: 1) a clinical study in which HIV-negative, non-pregnant young women will all receive condoms as standard of prevention, and be asked to use each of three placebo product for 1 month, in a randomly allocated order, to determine product preference (cross-over period), and then use their favorite product for up to 2 months; 2) qualitative in-depth interviews (IDIs) with women, their male partners, and health providers (HP); and 3) a structured discrete choice survey with the clinical study participants  and a community-recruited sample of product-naïve young women. Rankings, product relative preference (including male condoms), and use data for MPT placebo delivery formulations and specific delivery form attributes will be identified, with the overall goal of informing further development of MPT to optimize the likelihood of end-user adoption. In addition, data collection activities will be designed to inform development of culturally appropriate MPT communication strategies and educational messages tailored for young women in these sub-Saharan African settings.</p>\n<p>\n This research will help identify how products and their attributes are viewed by young women at dual risk of HIV and unintended pregnancy, and how messaging about the products can be appropriately tailored to increase adoption of novel formulation(s). This will enhance the potential public health impact of MPT to address the two critical women’s health issues.</p>\n
      • study_title<p>\n The TRIO Study: Acceptability of Different Multipurpose Prevention Technology (MPT) Delivery Methods (Placebo)</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/05/02
      • version_no1.0
      • date_of_protocol11-02-2015
      • study_drugPLACEBO FORMULATIONS OF VAGINAL RING, AN INTRAMUSCULAR INJECTION AND AN ORAL PILL.
      • disease_conditionHIV AND PREGNANCY PREVENTION
      • 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_name1. PLACEBO VAGINAL RING: A FLEXIBLE SILICON ELASTOMER 56mm IN DIAMETER AND 7.6mm THICK; PLACEBO ORAL PILL;
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmamagigto@yahoo.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_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_applicantKAWANGO AGOT
      • declaration_date107-05-2015
      • declaration_principal_investigatorNational Principal Investigator.
      • declaration_date207-05-2015
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Age 18-30</p>\n<p>\n In good health, as determined by the site Investigator or designee based on clinical history</p>\n<p>\n Willing and able to comply with study procedures and attend monthly follow-up visits</p>\n<p>\n Willing and able to provide informed consent</p>\n<p>\n Fluent in one of the languages being used in the study (Setswana and English in South Africa; Luo, Kiswahili, and English in Kenya)</p>\n<p>\n Not intending to travel outside of the research catchment area for the next 6 months.</p>\n<p>\n Sexually active defined by vaginal intercourse with a male at least 3 times in the past 3 months</p>\n
      • principal_exclusion_criteria<p>\n HIV positive</p>\n<p>\n Pregnant</p>\n<p>\n Prior participation in any HIV-prevention or MPT product demonstration study or clinical trial</p>\n<p>\n Any current or historical health or psychological issues that the site Investigator or his/her designee determines should exclude the potential participant</p>\n
      • primary_end_points<p>\n Three Primary Endpoints (outputs): product ratings after each period in the cross-over study; preference, indicated by choice among the three delivery forms at the end of the cross-over period; and use)</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_specifyAcceptability study.
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyAn acceptability study on HIV and Pregnancy prevention through multipurpose prevention technologies.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n APPROXIMATELY 15 20 personnel will be hired to work in the study team at Kenyan site. A few positions have now been filled:</p>\n<p>\n 1 Site Principal Investigator; KAWANGO AGOT, PhD; Dr. Kawango has been a principal Investigator in several HIV prevention studies in the fields of Pre-exposure prophylaxis among women, Behavioral Interventions and Male Circumcision.</p>\n<p>\n 2 Study Coordinator: FREDRICK OWINO, MBChB; Dr. Owino brings on board experience in coordinating clinical studies in the fields of Pre-exposure prophylaxis and Implementation science research.</p>\n<p>\n 3. Study Pharmacist; PAUL MAK'OKETCH, B Pharm; Dr. Makoketch has more that 3 years experience in pharmacy practice in clinical trials. Paul worked as Trial pharmacist in Pre-exposure prophylaxis with antiretrovirals.</p>\n<p>\n NurseCounsellors(2)</p>\n<p>\n Registered Clinical Officer(1)</p>\n<p>\n Pharmaceutical Technologist(1)</p>\n<p>\n Interviewers(1)</p>\n<p>\n Accountant(1)</p>\n<p>\n Data Clerks(4)</p>\n<p>\n STUDY SITE:</p>\n<p>\n The study will be conducted at IRDO’s Tuungane Youth Center Clinic, located within Kisumu City. Tuungane offers clinical services, including HIV care and treatment, HIV testing and counseling, STI screening and management, and voluntary medical male circumcision. In addition, Tuungane has a pharmacy where the study products will be stored and a qualified and registered Pharmaceutical Technologist who will dispense the study products. Tuungane also has a mini laboratory equipped with both -8 and -70 fridges for sample storage, a biosafety cabinet, centrifuges and ample storage space for other study supplies. The space, including examination rooms, is sufficient to comfortably accommodate the study.The study will be conducted at IRDO’s Tuungane Youth Center Clinic, located within Kisumu City. Tuungane offers clinical services, including HIV care and treatment, HIV testing and counseling, STI screening and management, and voluntary medical male circumcision. In addition, Tuungane has a pharmacy where the study products will be stored and a qualified and registered Pharmaceutical Technologist who will dispense the study products. Tuungane also has a mini laboratory equipped with both -8 and -70 fridges for sample storage, a biosafety cabinet, centrifuges and ample storage space for other study supplies. The space, including examination rooms, is sufficient to comfortably accommodate the study.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n This study will focus on MPT preference, choice, and use among young women (aged 18 to 30years) in sub-Saharan Africa as a primary target population due to high risk for both unintended pregnancy and HIV acquisition in this region. For this reason two study sites have been identified in Kenya and South Africa. The United States, the sponsor's host country,  does not face massive challenges of both unintended pregnancies and HIV infection among young women and would not make an ideal study location.</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute Ethics Review Committee (KEMRI-ERC)</p>\n
      • other_details_regulatory_rejected<p>\n NOT APPLICABLE</p>\n
      • other_details_regulatory_halted<p>\n NOT APPLICABLE</p>\n
      • estimated_duration18 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_stateYes
      • location_of_areaTuungane Youth Center Clinic
      • single_site_physical_addressAlong Mito-Jura Road, Kisumu
      • single_site_contact_personKawango Agot
      • single_site_telephoneTel: 057-2020132 Mobile: 0723511113
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listSouth Africa, Kenya
      • data_monitoring_committeeNo
      • total_enrolment_per_siteAPPROXIMATELY 140
      • total_participants_worldwide280
      • 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_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameARIANE
      • investigator1_middle_name
      • investigator1_family_nameVAN DER STRATEN
      • investigator1_qualificationPhD
      • investigator1_professional_address RTI International, San Francisco Project Office 351 California St, Suite 500 San Francisco, CA 94101-2414
      • investigator1_telephone+1-415-848-1322
      • investigator1_emailariane@rti.org
      • organisations_transferred_Yes
      • number_participantsAPPROXIMATELY 140
      • notification<p>\n We have attached a scanned copy of  bankers cheque of value 1000USD at the 'checklist' section of this online application. The actual cheque has been sent by courier to your offices and addressed to the Secretary of the ECCT.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • approval_date13-10-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted19-05-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n Please find attached documents as part of the executive summary report.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-10-06 12:09:05
      • created2015-04-15 13:00:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id265
        • application_id391
        • given_nameKawango
        • middle_name
        • family_nameAgot
        • qualificationPhD
        • professional_addressBaring Drive, Off Awuor Otiende Road, Opposite KBC Station P. O. Box 9171-40141 Kisumu, Kenya
        • telephoneTel: 057-2020132
        • emailmamagifto@yahoo.com
        • created2015-04-15 13:07:00
        • modified2015-05-19 12:12:03
    • SiteDetail(array)
      • 0(array)
        • id321
        • application_id391
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-04-15 13:07:00
        • modified2015-05-19 12:12:03
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id204
        • application_id391
        • sponsorRTI International
        • sponsor_type(null)
        • contact_personRachel Weinrib
        • addressRTI International, San Francisco Project Office. 351 California St, Suite 500. San Francisco, CA 94101-2414
        • telephone_number+1-415-848-1322
        • fax_number
        • cell_number+1-415-848-1322
        • email_addressrweinrib@rti.org
        • created2015-04-15 13:07:00
        • modified2015-05-19 12:12:03
  • 3(array)
    • Application(array)
      • id395
      • user_id581
      • trial_status_id5
      • abstract_of_study<p>\n This is a randomized, observer-blind, placebo-controlled, parallelgroup, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost regimens using Ad26.ZEBOV as prime and MVA-BN-Filo as boost vaccination, administered at 28-, 56- and 84-day (Group 1, 2 and 3 as above) intervals, in healthy adults and elderly participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in HIV infected participants and in healthy children in 2 age strata.</p>\n<p>\n The study consists of a screening phase of up to 8 weeks, a vaccination phase in which participants will be vaccinated at baseline (Day 1) followed by a boost vaccination on Day 29, 57 or 85, a postvaccination phase and long-term follow-up phase until Day 365.</p>\n<p>\n Participants in Cohort 1 substudy (Group 1 and 2) who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). All participants within a cohort will be followed in a blinded manner by the site until the last subject in that cohort has completed the study.</p>\n<p>\n This study will be conducted in Africa and the enrollment will take place sequentially in three cohorts: the first cohort will consist of healthy participants (18 - 70 years); the second cohort (2a) will include HIV-infected participants (18 to 50 years) and healthy children 12 to 17 years (cohort 2b); the third cohort will include children aged 4 to 11 years inclusive will be enrolled. Within each cohort, participants will be randomized in a 5:1 ratio to receive active vaccine versus placebo.</p>\n<p>\n Safety evaluations will include assessments of adverse events, an electrocardiogram (ECG) for adult participants at screening, physical examination, vital signs (blood pressure, pulse/heart rate, body temperature), clinical laboratory and pregnancy testing. An independent data monitoring committee (IDMC) will be established to monitor data on a regular basis to ensure the continuing safety of the participants enrolled in the study.</p>\n<p style=\"margin-left: 7pt;\">\n  </p>\n
      • study_title<p>\n A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa</p>\n
      • laymans_summary<p>\n Ebola virus disease is caused by an infection with a virus known as the Ebolavirus. The disease is characterized by symptoms such as fever, body aches, diarrhoea, bleeding, and vomiting.</p>\n<p>\n Vaccination is one of the most effective ways to prevent illness caused by viruses. A vaccine contains a non-functional part of the virus that is recognized by the body's protective immune system. The body then produces a response that prevents illness if the person is exposed to that virus again.</p>\n<p>\n The investigational treatment consists of a 2 dose vaccine regimen, 1 dose of Ad26.ZEBOV vaccine, followed by 1 dose of MVA-BN-Filo vaccine, for the prevention of Ebola virus disease (Zaïre ebolavirus species). The regimen has been studied in 14-, 28-, 56- and 84-day intervals in other clinical studies.</p>\n<p>\n In this study, researchers want to know the safety of the Ebola vaccine regimen in different groups or cohorts of participants at 28-, 56-, and 84-day schedules. In addition, researchers want to understand the immune responses induced by the vaccine regimens by performing some tests.</p>\n<p>\n Participants can take part in this study if they have never received an Ebola vaccine, have not been diagnosed with Ebola virus disease, and have not travelled to any place where Ebola virus disease was confirmed up to 1 month before the study starts. Participants in the human immunodeficiency virus (HIV*)-infected cohort should have a documented HIV infection for at least 6 months before study start and taking medicines for the treatment of HIV infection for the duration of the study.</p>\n<p>\n *HIV infection affects cells of the immune system and decreases their ability to fight infections.</p>\n<p>\n During the study, participants will go through screening to confirm if they can take part in the study. Participants will then be divided into 4 groups as shown below.</p>\n<ul>\n <li>\n Cohort 1: Healthy adult and elderly participants between 18 to 70 years of age</li>\n <li>\n Cohort 2: Participants with HIV infection between 18 to 50 years of age</li>\n <li>\n Cohort 2b: Healthy children between 12 to 17 years of age</li>\n <li>\n Cohort 3: Healthy children between 4 to 11 years of age</li>\n</ul>\n<p>\n Within each Cohort, participants will be further divided into 2 or 3 groups to test the different intervals between the first and the second vaccine.</p>\n<p>\n All participants will receive either study vaccine (Ad26.ZEBOV and MVA-BN-Filo) or placebo, which does not contain the study vaccine, but looks like it. All vaccines will be given as an injection in the muscle. The first dose (Ad26.ZEBOV or placebo) will be given on Day 1 and the second dose (MVA-BN-Filo or placebo) will be given on either Day 29, 57, or 85, depending on which group and cohort the participant is in.</p>\n<p>\n At selected study sites for Cohort 1, a third vaccination with Ad26.ZEBOV (booster dose), will be given at least 1 year after the first dose to participants who are eligible and agree to a booster vaccination. This booster dose will only be studied at 28- and 56-day schedule to assess safety and immune responses induced by the booster dose.</p>\n<p>\n During the study, participants will undergo different study assessments and tests. It includes blood tests, vital signs (such as pulse, blood pressure, and temperature), electrocardiograms, physical exams, pregnancy test for women, and any side effects reported by the participants. Blood samples will be taken at several time points to know how many people responded to the vaccine regimen and to which extent. There will be a follow-up phase until Day 365 to monitor participants’ health. Participants in Cohort 1 who receive the booster vaccination with Ad26.ZEBOV will also be followed up for safety and immune response assessments up to 1 year after the booster vaccination.</p>\n<p>\n The overall duration of the study can be up to 3 to 4 years.</p>\n
      • short_titleJanssen Ebola vaccine study
      • protocol_noECCT/15/05/01
      • version_no1.0
      • date_of_protocol30-03-2015
      • study_drugEbola Ad26.ZEBOV and MVA-BN-Filo
      • disease_conditionEbola prevention
      • 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
      • comparatorYes
      • comparator_nameNormal saline 0.9%
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmkatwere@its.jnj.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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantOctavia Magopane
      • declaration_date108-05-2015
      • declaration_principal_investigatorProf Omu Anzala
      • declaration_date208-05-2015
      • placebo_presentYes
      • study_objectives<p>\n The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata</p>\n
      • principal_inclusion_criteria<p style=\"margin-left:27.0pt;\">\n This study will enroll a planned total number of 1188 subjects, who never received any candidate Ebola vaccine before and without prior exposure to Ebola virus (including travel to epidemic Ebola areas less than 1 month prior to screening) or diagnosis of Ebola virus disease.</p>\n<p>\n             The study is comprised of 4 cohorts, which will be enrolled sequentially:</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 1: healthy adult and elderly subjects (aged 18 years up to 70 years inclusive)</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 2a:  HIV-infected subjects (aged 18 to 50 years inclusive, healthy children in 3 age strata)</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 2b: adolescents aged 12 to 17 years inclusive</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 3: children aged 6 to 11 years inclusive</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 4: young children aged 1 to 5 years inclusive</p>\n<p style=\"margin-left:.75in;\">\n The inclusions and exclusion criteria has been well indicated in section 4 of the protocol. </p>\n
      • principal_exclusion_criteria<p>\n The inclusions and exclusion criteria has been well indicated in section 4 of the protocol. </p>\n
      • primary_end_points<p>\n <strong>Primary Objective</strong></p>\n<p>\n The primary objective is to assess the safety and tolerability of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as heterologous prime-boost regimens on Days 1 and 29, Days 1 and 57, or Days 1 and 85, in healthy adults, including elderly subjects, HIV-infected subjects and healthy children in 3 age strata.</p>\n<p>\n <strong>Secondary Objective</strong></p>\n<p>\n The secondary objective is to assess immune responses to the EBOV GP over time of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered IM as heterologous prime-boost regimens on Days 1 and 29, Days 1 and 57, or Days 1 and 85, in healthy adults, including elderly subjects, HIV-infected subjects and healthy children in 3 age strata.</p>\n<p>\n <strong>Exploratory Objectives</strong></p>\n<p>\n The exploratory objectives are:</p>\n<p>\n To further explore humoral and cellular immune responses to different EBOV GPs and the adenovirus and MVA backbone of the various vaccination schedules tested.</p>\n<p>\n To explore humoral and cellular immune responses to the SUDV GP, MARV GP and TAFV NP, if assays are available.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The site Principal Investigator: </p>\n<p>\n <strong>Prof. Omu Anzala MBCHB PHD</strong></p>\n<p>\n Principal Investigator</p>\n<p>\n KAVI –Institute of Clinical Research</p>\n<p>\n College of Health Sciences -University of Nairobi</p>\n<p>\n PO Box 19676 Nairobi, Kenya</p>\n<p>\n Tel: +254 727555279</p>\n<p>\n Fax: 2714613</p>\n<p>\n Email: <a href=\"mailto:oanzala@kaviuon.org\">oanzala@kaviuon.org</a></p>\n<p>\n  </p>\n<p>\n The Sub-Investigator are as follows.</p>\n<p>\n <strong>Dr. Gaudensia N. Mutua MBChB MPH</strong></p>\n<p>\n Sub- Investigator</p>\n<p>\n KAVI-ICR Kangemi Site</p>\n<p>\n College of health Sciences -University of Nairobi</p>\n<p>\n PO Box 19676 Nairobi, Kenya</p>\n<p>\n Tel: +254 733826815</p>\n<p>\n Email: <a href=\"mailto:gmutua@kaviuon.org\">gmutua@kaviuon.org</a></p>\n<p>\n <strong>Dr. Gina Muthoni Ouattara MBChB</strong></p>\n<p>\n Sub Investigator KAVI-ICR KNH Site</p>\n<p>\n College of health Sciences -University of Nairobi</p>\n<p>\n PO Box 19676 Nairobi, Kenya</p>\n<p>\n Tel: +254 722659169</p>\n<p>\n Fax: 2714613</p>\n<p>\n Email: <a href=\"mailto:gouattara@kaviuon.org\">gouattara@kaviuon.org</a></p>\n<p>\n <strong>Dr Joshua Kimani</strong></p>\n<p>\n Sub - Investigator<br />\n SWOP Clinic Network<br />\n University of Nairobi/University of Manitoba<br />\n PO Box 19676-00202 Nairobi, Kenya<br />\n Tel +254-733719711<br />\n Email: <a href=\"mailto:jkimani@csrtkenya.org\"><strong>jkimani@csrtkenya.org</strong></a></p>\n<p>\n  </p>\n<p>\n The site has a total of 60 members of staff. Doctors ,Clinical officers, Nurses, Lab technologist, ICT staff,community, Finance and Administration. </p>\n<p>\n There are three facilities KAVI-ICR (KNH and Kangemi) and Comprehensive care Clinic  for HIV positive volunteers. Emergency facilities are in place at all facilities. The site also has established CAB members. </p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Uganda NDA: 08 May 2015</p>\n<p>\n Ministère de la Santé de la République de Côte d’Ivoire: 08 May 2015</p>\n<p>\n Monsieur le Ministre de la Santé S/C Burkina Faso: 08 May 2015</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable </p>\n
      • other_details_regulatory_halted<p>\n Not applicable </p>\n
      • estimated_duration12 Months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorSaline 0.9%
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKAVI –Institute of Clinical Research
      • single_site_physical_addressKAVI Institute of Clinical Research ( KAVI-ICR) 2nd Floor, College of Health Sciences University of Nairobi, Kenyatta National Hospital Along Ngong Road
      • single_site_contact_personJacquelyn Rita Nyange
      • single_site_telephone+ 254 722 207417
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites
      • multi_country_listKenya, Uganda, Tanzania, Ghana, Burkina Faso and Ivory Coast.
      • data_monitoring_committeeYes
      • total_enrolment_per_site250 at a single site
      • total_participants_worldwide1188
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyA cohort of HIV infected participants will be enrolled in the study.
      • investigator1_given_nameProf Omu
      • investigator1_middle_nameAggrey
      • investigator1_family_nameAnzala
      • investigator1_qualificationMBCHB, PHD
      • investigator1_professional_addressKAVI Institute of Clinical Research ( KAVI-ICR) 2nd Floor, College of Health Sciences University of Nairobi, Kenyatta National Hospital Along Ngong Road
      • investigator1_telephone+254 727555279
      • investigator1_emailoanzala@kaviuon.org
      • organisations_transferred_No
      • number_participants250
      • notification<p>\n A joint review has been requsted with particioanting Health Authority. </p>\n
      • approval_date17-12-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
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      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-05-05 09:24:32
      • created2015-05-08 14:40:18
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id269
        • application_id395
        • given_nameProf Omu
        • middle_nameAggrey
        • family_nameAnzala
        • qualificationMBCHB, PHD
        • professional_addressKAVI Institute of Clinical Research ( KAVI-ICR) 2nd Floor, College of Health Sciences University of Nairobi, Kenyatta National Hospital Along Ngong Road
        • telephone+254 727555279
        • emailoanzala@kaviuon.org
        • created2015-05-08 17:54:24
        • modified2020-05-05 09:24:32
    • SiteDetail(array)
      • 0(array)
        • id325
        • application_id395
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-05-08 17:54:24
        • modified2020-05-05 09:24:32
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id208
        • application_id395
        • sponsorJanssen Vaccines & Prevention B.V.
        • sponsor_typeIndustry
        • contact_personNicolette Muller
        • address2 Medical Road, Midrand, South Africa
        • telephone_number+27 11 518 7037
        • fax_number+27 11 518 7102/3
        • cell_number+27 76 620 0359
        • email_addressnmuller@its.jnj.com
        • created2015-05-08 17:54:24
        • modified2020-05-05 09:24:32
  • 4(array)
    • Application(array)
      • id393
      • user_id89
      • trial_status_id(null)
      • abstract_of_study<p>\n Dafra Pharma and CCR-KEMRI have initiated the first in man clinical Phase 1 study<br />\n using single oral doses of 50 mg, 100 mg and 150 mg of oleylphosphocholine in healthy<br />\n adult males (protocol DRD140-L2.2012, SSC #2512). The study made use of a capsule<br />\n formulation of oleylphophocholine containing 50 mg of active ingredient. The subjects of<br />\n the first three cohorts were receiving one, two or three of those capsules as a single dose.<br />\n Based on the positive results obtained so far, two additional cohorts of 10 volunteers are<br />\n now planned to be dosed with single dose of 200 mg and 250 mg, upon approval by<br />\n KEMRI IRB. The capsule formulation of oleylphosphocholine was of limited shelf life and was only<br />\n meant to be used for early clinical studies. Since the initiation of the Phase 1 trial, the<br />\n pharmaceutical research around the formulation of oleylphosphocholine has progressed<br />\n and the final formulation of the active ingredient intended to be marketed has become<br />\n available. This formulation is in the form of 50 mg oral solid tablets. Our intention is to<br />\n continue the Phase 1 protocol DRD140-L2.2012, SSC #2512 with this new formulation,<br />\n but before, we wish to confirm that both the capsule and tablet formulations of the active<br />\n ingredient are comparable in terms of safety/tolerance, and pharmacokinetics.The primary objective is to evaluate safety and tolerability of single dose 100 mg<br />\n oleylphosphocholine oral solid tablets in healthy male volunteers.The secondary objective is to obtain data on pharmacokinetics following oral<br />\n administration of single dose 100 mg tablets oleylphosphocholine in human, and to<br />\n calculate bioequivalence with the capsule formulation</p>\n<p>\n  </p>\n
      • study_title<p>\n Plasma concentration profiles after oral<br />\n administration of oleylphosphocholine tablet<br />\n formulation: safety, tolerability and pharmacokinetics<br />\n of 100 mg single dose in healthy male volunteers.</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/04/02
      • version_no2.1
      • date_of_protocol03-02-2015
      • study_drugOleylphosphocholine (OlPC)
      • disease_conditionleishmaniasis
      • 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_nameOleylphosphocholine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssnjoroge@kemri.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)
      • 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_applicantDr Rashid J R
      • declaration_date129-04-2015
      • declaration_principal_investigatorDr Njenga S Njoroge CO_PI
      • declaration_date229-04-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Healthy males, adults, aged 18-45 years inclusively at the time of screening.<br />\n · Weight between 45 kg and 80 kg inclusively.<br />\n · Written informed consent obtained from the participant before study start.</p>\n
      • principal_exclusion_criteria<p>\n HIV positive or other immunosuppressive statusSymptomatic infection<br />\n · Concomitant exposure to other investigational medicinal products<br />\n · History of alcohol or drug abuse<br />\n · Known hypersensitivity to miltefosine<br />\n · Known skin condition which could confound assessments of rash as an adverse event.<br />\n · Lipid disorders, including abnormal blood levels of total cholesterol, HDL, LDL, and<br />\n triglycerides.<br />\n · Laboratory result abnormalities, including clinically significant abnormal ECG, liver function<br />\n tests more than x3 upper limit of normal, creatinine outside normal range.<br />\n · Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition. Or any<br />\n other findings that in the opinion of the PI may increase the risk to the participant from<br />\n participating in the study.<br />\n · Other condition that in the opinion of the investigator would jeopardize the safety or rights of<br />\n a participant in the trial or would render the participant unable to comply with the protocol.</p>\n
      • primary_end_points<p>\n Documentation of solicited and spontaneously reported adverse events after administration<br />\n during a 29-day follow-up period, i.e. from day 0 (day of administration) to day 28 postadministration.<br />\n · Documentation of the occurrence of serious adverse events (SAE) throughout the study<br />\n period.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • 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_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The Centre for Clinical Research (CCR) at KEMRI was established in 1983 and has since grown to<br />\n an international centre for clinical research. The facilities consist of 30 clinical beds, 10 of which are<br />\n dedicated to Phase 1 clinical trials.<br />\n CCR has clinical laboratories for haematology, clinical biochemistry and parasitology. The centre<br />\n also has a full-fledged radiology Unit as well as a facility for upper-GI and lower-GI endoscopy. The<br />\n laboratory equipments are regularly maintained and serviced. All laboratories have SOPs for<br />\n maintenance and for running the different tests.<br />\n In terms of personnel the centre has 6 highly qualified doctors and a clinical officer. The laboratory<br />\n has 10 highly qualified technical employees. There is also 1 radiologist, 3 radiographers and 17<br />\n research nurses. A pharmacy and a qualified pharmacist are also present on site.<br />\n This study team is highly experienced in conducting complex studies and complying with ICH/GCP<br />\n requirements. All CCR scientific, nursing and laboratory staffs are GCP/GcLP trained, and biannually undergo GCP/GcLP refresher courses.<br />\n The team of CCR has conducted several clinical trials including Phase 1 studies.</p>\n
      • other_details_explanation<p>\n Dafra Pharma distributes its products exclusively on the African market and has always<br />\n focused on making drugs available for the African population, where the need is high and<br />\n drugs need to be affordable. Therefore it is ethically fair that the African population and<br />\n scientific community, who are likely to use the medicine in clinical practice, participate in<br />\n the clinical development. This will allow reliable and accurate data about tolerance and<br />\n pharmacokinetics to be compiled in the target population.<br />\n Dafra Pharma is developing the investigational drug oleylphosphocholine (OlPC) as a<br />\n new therapeutic treatment option for visceral leishmaniasis. This neglected parasitic<br />\n disease does not occur in the country of the sponsor (Belgium), whereas it is endemic to<br />\n Kenya. The goal of the current Phase I study is to assess the safety and pharmacokinetic<br />\n profile of OlPC in healthy Kenyan volunteers.<br />\n  </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_durationEnrolment and clinical part: up to 3 months Data analysis and preliminary report: 2 months Final report: 1 month
      • 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
      • single_site_physical_addressoff mbagathi way
      • single_site_contact_personDr J R Rashid
      • single_site_telephone254 20 2726781
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site10
      • total_participants_worldwide10
      • 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_female0
      • 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_nameRashid Juma
      • investigator1_middle_name
      • investigator1_family_nameRavasco
      • investigator1_qualificationMedical Doctor MBChB, MMed(medicine)
      • investigator1_professional_addressCenter for Clinical Research Kenya Medical Research Institute (KEMRI) Box 20778-00202 Nairobi, Kenya
      • investigator1_telephone254 20 2726781
      • investigator1_emailjrashid@kemri.org
      • organisations_transferred_No
      • number_participants10
      • notification
      • approval_date15-06-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted29-04-2015
      • 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)
      • modified2015-06-15 19:23:44
      • created2015-04-29 08:57:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id266
        • application_id393
        • given_nameRavasco
        • middle_nameRashid
        • family_nameJuma
        • qualificationMBChB Mmed(Internal Medicine)
        • professional_address KEMRI 54840-00200 Nairobi
        • telephone0723726526
        • emailjrashid@kemri.org
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
    • SiteDetail(array)
      • 0(array)
        • id322
        • application_id393
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id205
        • application_id393
        • sponsorDafra Pharma International NV
        • sponsor_type(null)
        • contact_personBruno Jansen
        • addressSlachthuisstraat 30/7, 2300 Turnhout, Belgium
        • telephone_number+32 14 61 78 20
        • fax_number+32 14 47 29 90
        • cell_number+32 475 912 920
        • email_addressbruno.jansen@dafra.be
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
• page_options(array)
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• redir
• $request->data(array)
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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

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    • 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