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• trial_statuses(array)
  • 1Recruiting
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  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id449
      • user_id309
      • trial_status_id7
      • abstract_of_study<p>\n ABSTRACT Background Laryngeal mask airways (LMAs) are widely used in surgery and are considered to be generally safe. Postoperative sore throat (POST) is a frequent complication following LMA use and can be very distressing to patients. The use of a laryngeal mask airway cuff pressure of between 23 and 24mmhg in alleviating postoperative sore throat has not been investigated. Primary objective • To determine the occurrence of POST between the intervention group in which LMA cuff pressures will be adjusted to 23-24mmhg and the control group in whom only monitoring of LMA cuff pressures will be done Secondary Objectives ï‚— To compare the laryngeal mask airway pressures between the two study groups ï‚— To determine the severity of postoperative sore throat between the two study groups Study Design: A single blind randomized control trial Methods A sample size of eighty patients will be used. This will include ASA 1 and ASA II patients scheduled to receive general anaesthesia with use of an LMA and are having elective surgery Intervention: Laryngeal mask airway cuff pressures will be adjusted in the intervention group by the principal investigator to a pressure of between 23 and 24mmhg.The none intervention group will only have LMA cuff pressures monitored. Data collection Patients will be interviewed at two, six and twelve hours postoperatively. Data of their baseline characteristics, occurrence and severity of POST will be collected. If POST is present, a Numerical Rating Scale (NRS) will be used to assess its severity. Cuff pressures in the two study groups will also be determined Data Analysis Data collected using questionnaires and will be keyed into an MS Excel database and analyzed using Stata Version 10. Occurrence of POST in both study arms will be presented as a proportion and reported together with the 95% confidence interval. The difference in means of cuff pressures in the study arms will be analyzed using the Student t-test. In the event that the cuff pressures do not meet the rules of normality, the Mann-Whitney non-parametric test will be applied. A p value of <0.05 will be considered statistically significant.</p>\n
      • study_title<p>\n EFFECT OF LARYNGEAL MASK AIRWAY MANOMETRY ON POST OPERATIVE SORE THROAT IN SPONTANEOUSLY BREATHING ADULT PATIENTS PRESENTING FOR SURGERY AT AGA KHAN UNIVERSITY HOSPITAL, NAIROBI.</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/11/02
      • version_noRef 2015/REC - 12
      • date_of_protocol24-07-2015
      • study_drugEFFECT OF LARYNGEAL MASK AIRWAY MANOMETRY ON POST OPERATIVE SORE THROAT
      • disease_condition POST OPERATIVE SORE THROATIN SPONTANEOUSLY BREATHING ADULT PATIENTS PRESENTING FOR SURGERY AT AGA KHAN UNIVERSITY HOSPITAL, NAIROBI.
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
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      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameCuff pressure gauge for Larngeal Mask Airway manometry
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdwaruingi@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
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      • declaration_applicantDr David Njoroge Waruingi
      • declaration_date110-11-2015
      • declaration_principal_investigatorNational Principal Investigator
      • declaration_date210-11-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Inclusion criteria All ASA I and II patients between 18-65 years scheduled to receive general anaesthesia with a laryngeal mask airway for elective surgery</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria • History of ongoing upper respiratory tract infection. • Patients with a failed LMA insertion defined as an unsuccessful laryngeal mask airway placement after two attempts. • Patients with severe gastro oesophageal reflux disease. • Patients with a symptomatic hiatus hernia. • Patients with a BMI> 40kg/m2. • Patients undergoing ENT-Ear Nose and Throat Procedures.</p>\n
      • primary_end_points<p>\n Primary objective • To determine the occurrence of POST between the intervention group in which LMA cuff pressures will be adjusted to 23-24mmhg and the control group in whom only monitoring of LMA cuff pressures will be done Secondary Objectives ï‚— To compare the laryngeal mask airway pressures between the two study groups ï‚— To determine the severity of postoperative sore throat between the two study groups</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • 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_other1
      • trial_other_specifyAim of the study\nTo assess the effect of laryngeal mask airway cuff pressure monitoring on incidence of post-operative sore throat in spontaneously breathing adult surgical patients.\n
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n NA</p>\n
      • other_details_explanation<p>\n NA</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n Research and Ethics Committee Aga Khan UNiversity Hospital 30270-00100 Nairobi</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration3 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_comparatorIntervention: Laryngeal
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaAga Khan University Hospital Nairobi
      • single_site_physical_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
      • single_site_contact_personDr David Njoroge Waruingi
      • single_site_telephone254721994598
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site80
      • total_participants_worldwide80
      • 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_nameDr David Njoroge Waruingi
      • investigator1_middle_name
      • investigator1_family_nameDavid Njoroge Waruingi
      • investigator1_qualificationMBChB MMed Anaesthesiology
      • investigator1_professional_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
      • investigator1_telephone254721994598
      • investigator1_emaildwaruingi@gmail.com
      • organisations_transferred_No
      • number_participants80
      • notification
      • approval_date02-12-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted10-11-2015
      • 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)
      • modified2015-12-02 12:36:02
      • created2015-11-10 11:31:39
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id299
        • application_id449
        • given_nameProf Vitalis
        • middle_name
        • family_nameMungayi
        • qualificationMBChb MMed Anaesthesiology FICM (SA)
        • professional_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
        • telephone254724904010
        • emailvitalis.mungayi@aku.edu
        • created2015-11-10 11:40:39
        • modified2015-11-10 15:43:12
      • 1(array)
        • id300
        • application_id449
        • given_nameDr Edna Kemunto
        • middle_name
        • family_name Gisore
        • qualificationMBChb MMed Anaesthesiology Cardiac Anaesthesia (UK)
        • professional_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
        • telephone254722287339
        • emailegisore2000@yahoo.com
        • created2015-11-10 11:53:19
        • modified2015-11-10 15:43:12
      • 2(array)
        • id301
        • application_id449
        • given_nameDr David Njoroge
        • middle_name
        • family_nameWaruingi
        • qualificationMBChb MMed Anaesthesiology
        • professional_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
        • telephone254721994598
        • emaildwaruingi@gmail.com
        • created2015-11-10 14:51:22
        • modified2015-11-10 15:43:12
    • SiteDetail(array)
      • 0(array)
        • id360
        • application_id449
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-11-10 11:40:39
        • modified2015-11-10 15:43:12
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id234
        • application_id449
        • sponsorAga Khan University Hospital Nairobi
        • sponsor_type(null)
        • contact_person
        • addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
        • telephone_number254721994598
        • fax_number
        • cell_number254721994598
        • email_addressdavid.waruingi@aku.edu
        • created2015-11-10 11:40:39
        • modified2015-11-10 15:43:12
  • 1(array)
    • Application(array)
      • id446
      • user_id77
      • trial_status_id4
      • abstract_of_study<div>\n ABSTRACT</div>\n<div>\n The study titled “A Randomized Evaluation of Antiretroviral Therapy Alone or with</div>\n<div>\n Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive</div>\n<div>\n Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited</div>\n<div>\n Settings (REACT-KS)” is a phase III, open-label, prospective, randomized study</div>\n<div>\n stratified by CD4+ lymphocyte cell count and antiretroviral therapy (ART) history.</div>\n<div>\n This study will compare ART alone, or with delayed chemotherapy to ART with</div>\n<div>\n immediate adjunctive chemotherapy for initial treatment of limited stage AIDSrelated</div>\n<div>\n Kaposi’s sarcoma (AIDS-KS), in chemotherapy and radiation treatment naïve</div>\n<div>\n HIV-1 infected participants who are currently not receiving ART.</div>\n<div>\n The target population includes males and females  18 years of age with the</div>\n<div>\n following characteristics: documentation of HIV-1 infection, biopsy diagnostic of KS,</div>\n<div>\n current limited stage KS (T0 and some T1 stage KS), systemic chemotherapy for KS</div>\n<div>\n and radiation treatment naïve, and currently not receiving ART. A total of 468</div>\n<div>\n participants (234 in each Arm of Step 1) will be enrolled across all sites, with the</div>\n<div>\n KEMRI/CDC site proposing to contribute about 50 participants, and could be</div>\n<div>\n more given enrollment across sites is competitive. Randomization will be stratified</div>\n<div>\n by screening peripheral blood CD4+ lymphocyte cell count (< 200 or  200</div>\n<div>\n cells/mm³) and ART history (naïve or experienced). At study entry participants will</div>\n<div>\n be randomized 1:1 to one of the following arms in Step 1: Arm 1A, Co-formulated</div>\n<div>\n efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) and arm 1B,</div>\n<div>\n co-formulated EFV/FTC/TDF and ET. In Step 2, at the discretion of the site</div>\n<div>\n investigator, after confirmation of disease progression by the IERC (Independent</div>\n<div>\n Endpoint Review Committee), participants who experience KS progression in Arm</div>\n<div>\n 1A will receive ET in addition to co-formulated EFV/FTC/TDF. In step 3,</div>\n<div>\n participants who received ET will remain on the study for 240 weeks (96 weeks +</div>\n<div>\n 144 weeks of follow-up for safety). Participants never receiving etoposide (VePesid®,</div>\n<div>\n ET) will be followed up for 96 weeks.</div>\n<div>\n The primary endpoint incorporates KS tumor response, KS progression, loss to</div>\n<div>\n follow-up, and initiation of new chemotherapy agent other than ET, as an ordinal,</div>\n<div>\n categorical outcome i.e. failure, stable and respose. The main interest of the study is</div>\n<div>\n the outcome at 48 weeks after the treatment initiation. KS follow-up to 96 weeks of</div>\n<div>\n SSA (Protocol No ACTG A5264), Version 1.1 Page 5 of 96</div>\n<div>\n the study will allow assessments of study arm differences beyond 48 weeks. The</div>\n<div>\n primary analysis will be conducted when the data on 96-week follow-up are</div>\n<div>\n completed on all the study participants (at Step 2 completion).</div>\n
      • study_title<div>\n A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy</div>\n<div>\n versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of</div>\n<div>\n Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS)</div>\n
      • laymans_summary(null)
      • short_titleA5264
      • protocol_noECCT/15/11/01
      • version_noversion 1.0
      • date_of_protocol04-08-2010
      • study_drugStudy provided study products are etoposide (VePesid®), FTC/TDF (Truvada®), EFV (Stocrin®), and EFV/FTC/TDF (Atripla®). Study treatment is considered etoposide (VePesid®) chemotherapy product plus, study provided ART or an approved, non-study provide
      • disease_conditionAIDS KS
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid1
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameVP-16, toposar, vepeside
      • 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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
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      • declaration_applicantDr. Victor Otieno Mudhune
      • declaration_date105-11-2015
      • declaration_principal_investigatorDr. Victor Otieno Mudhune - A5264 Study PI
      • declaration_date205-11-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<div>\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme</div>\n<div>\n or chemiluminescence immunoassay (E/CIA) test kit at any time prior to</div>\n<div>\n study entry and confirmed by a licensed Western blot or a second antibody</div>\n<div>\n test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1</div>\n<div>\n antigen, plasma HIV-1 RNA viral load.</div>\n<div>\n SSA (Protocol No ACTG A5264), Version 1.1 Page 11 of 96</div>\n<div>\n b. Biopsy diagnostic of KS at any time prior to study entry.</div>\n<div>\n c. Current limited stage KS using the ACTG criteria. (Limited stage KS is</div>\n<div>\n defined as stage T0 and some presentations of stage T1 KS).</div>\n<div>\n d. A minimum of 5 cutaneous marker lesions</div>\n<div>\n e. The following laboratory values obtained within 14 days prior to study entry:</div>\n<div>\n ï‚· Absolute neutrophil count (ANC)  1,000 cells/mm3.</div>\n<div>\n ï‚· Hemoglobin  9.0 g/dL.</div>\n<div>\n ï‚· Platelet count  100,000/mm3.</div>\n<div>\n ï‚· Calculated creatinine clearance of ≥ 60 mL/min using the Cockroft-</div>\n<div>\n Gault formula (defined in the study protocol).</div>\n<div>\n ï‚· AST (SGOT), ALT (SGPT), and alkaline phosphatase < 5 ï‚´ ULN.</div>\n<div>\n ï‚· Total bilirubin of < 1.5 X ULN.</div>\n<div>\n f. Female participants of reproductive potential must have a negative serum or</div>\n<div>\n urine pregnancy test with a sensitivity of 15-25mlIU/ml performed within 7</div>\n<div>\n days prior to study entry.</div>\n<div>\n g. All participants must agree not to participate in a conception process (e.g.,</div>\n<div>\n active attempt to become pregnant or to impregnate, donate sperm, in vitro</div>\n<div>\n fertilization).</div>\n<div>\n h. Female participants who are participating in sexual activity that could lead to</div>\n<div>\n pregnancy must agree to use a combination of TWO of the following</div>\n<div>\n methods:</div>\n<div>\n ï‚· Condoms (male or female) with or without a spermicidal agent.</div>\n<div>\n ï‚· Diaphragm or cervical cap with spermicide</div>\n<div>\n ï‚· IUD</div>\n<div>\n ï‚· Hormonal-based contraception. This must be used while receiving ET,</div>\n<div>\n efavirenz, rifampicin, or other rifamycin, and for 12 weeks after stopping</div>\n<div>\n these drugs.</div>\n<div>\n i. Ability to swallow oral medications.</div>\n<div>\n j. Men and women, age  18 years.</div>\n<div>\n SSA (Protocol No ACTG A5264), Version 1.1 Page 12 of 96</div>\n<div>\n k. Karnofsky performance score  60 within 30 days prior to entry.</div>\n<div>\n l. Ability and willingness of participant or legal guardian/representative to</div>\n<div>\n provide informed consent.</div>\n<div>\n m. Peripheral blood CD4+ lymphocyte cell count obtained within 30 days prior</div>\n<div>\n to study entry at a DAIDS-approved laboratory.</div>\n<div>\n n. For treatment-experienced patients, the availability of an ART regimen that</div>\n<div>\n includes at least two ART drugs that in the opinion of the site investigator are</div>\n<div>\n expected to have activity based on historical genotypic testing (if available)</div>\n<div>\n and treatment history.</div>\n<div>\n o. For participants who are to receive ART other than EFV/TDF/FTC, the</div>\n<div>\n availability of those ART components.</div>\n<div>\n Step 2 inclusion criteria include:</div>\n<div>\n a. KS progression after a complete or partial response as defined in sections 7.1</div>\n<div>\n of the protocol, while on Step 1 Arm 1A, between weeks 8 and 80.</div>\n<div>\n b. Need for ET for treatment of KS progression, in the opinion of the site</div>\n<div>\n investigator, after confirmation of KS progression by the IERC.</div>\n<div>\n c. Willingness to receive ET for treatment of KS progression.</div>\n<div>\n d. Female participants of reproductive potential must have a negative serum or</div>\n<div>\n urine pregnancy test with a sensitivity of 15-25mlIU/ml performed within 7</div>\n<div>\n days prior to initiating ET.</div>\n<div>\n e. Karnofsky Performance Score ≥ 50.</div>\n<div>\n f. The following laboratory values obtained within 14 days prior to Step 2</div>\n<div>\n entry:</div>\n<div>\n  ANC  1,000 cells/mm3.</div>\n<div>\n  Hemoglobin  9.0 g/dL.</div>\n<div>\n  Platelet count  100,000/mm3.</div>\n<div>\n  Estimated creatinine clearance of ≥ 60 mL/min using the Cockroft-Gault</div>\n<div>\n formula as indicated in the protocol.</div>\n<div>\n SSA (Protocol No ACTG A5264), Version 1.1 Page 13 of 96</div>\n<div>\n  AST (SGOT), ALT (SGPT), and alkaline phosphatase < 5 ï‚´ ULN.</div>\n<div>\n  Total bilirubin of < 1.5 X ULN.</div>\n<div>\n g. Ability to swallow oral medications.</div>\n<div>\n h. All participants must agree not to participate in a conception process (e.g.,</div>\n<div>\n active attempt to become pregnant or to impregnate, donate sperm, in vitro</div>\n<div>\n fertilization).</div>\n<div>\n i. Female participants who are participating in sexual activity that could lead to</div>\n<div>\n pregnancy must agree to use a combination of TWO of the following</div>\n<div>\n methods:</div>\n<div>\n ï‚· Condoms (male or female) with or without a spermicidal agent.</div>\n<div>\n ï‚· Diaphragm or cervical cap with spermicide</div>\n<div>\n ï‚· IUD</div>\n<div>\n ï‚· Hormonal-based contraception. This must be used while receiving ET,</div>\n<div>\n EFV, RIF, or other rifamycin, and for 12 weeks after stopping these</div>\n<div>\n drugs.</div>\n<div>\n Step 3 inclusion criteria include:</div>\n<div>\n a. Received at least one dose of ET (Arm 1B or Arm 2A).</div>\n<div>\n 5.4. Exclusion Criteria</div>\n<div>\n Step 1 exclusion criteria:</div>\n<div>\n a. Any manifestation of KS which, in the opinion of the site investigator,</div>\n<div>\n requires immediate chemotherapy.</div>\n<div>\n b. Receipt of ART within 6 months prior to study entry.</div>\n<div>\n c. Biopsy proven KS during previous ART.</div>\n<div>\n d. Breastfeeding.</div>\n<div>\n e. Allergy/sensitivity to any study drug or its formulations.</div>\n<div>\n f. Any prior systemic anti-neoplastic treatment for KS (including</div>\n<div>\n chemotherapy, biological therapy, immunotherapy or investigational</div>\n<div>\n therapy).</div>\n<div>\n SSA (Protocol No ACTG A5264), Version 1.1 Page 14 of 96</div>\n<div>\n g. Any prior local treatment of cutaneous marker lesions unless there was</div>\n<div>\n evidence of a clear-cut progression of the lesion.</div>\n<div>\n h. Receipt of any investigational therapy within 30 days prior to study entry.</div>\n<div>\n i. Current or anticipated receipt of any of the prohibited medications indicated</div>\n<div>\n in the protocol under section 5.4.2.</div>\n<div>\n j. In the opinion of the site investigator, any psychological or social condition,</div>\n<div>\n or addictive disorder that would preclude compliance with the protocol.</div>\n<div>\n k. Current chronic, acute, or recurrent infections that are serious, in the opinion</div>\n<div>\n of the site investigator, for which the participant has not completed at least 14</div>\n<div>\n days of therapy prior to study entry and/or is not clinically stable.</div>\n
      • principal_exclusion_criteria<div>\n Exclusion Criteria</div>\n<div>\n Step 1 exclusion criteria:</div>\n<div>\n a. Any manifestation of KS which, in the opinion of the site investigator,</div>\n<div>\n requires immediate chemotherapy.</div>\n<div>\n b. Receipt of ART within 6 months prior to study entry.</div>\n<div>\n c. Biopsy proven KS during previous ART.</div>\n<div>\n d. Breastfeeding.</div>\n<div>\n e. Allergy/sensitivity to any study drug or its formulations.</div>\n<div>\n f. Any prior systemic anti-neoplastic treatment for KS (including</div>\n<div>\n chemotherapy, biological therapy, immunotherapy or investigational</div>\n<div>\n therapy).</div>\n<div>\n SSA (Protocol No ACTG A5264), Version 1.1 Page 14 of 96</div>\n<div>\n g. Any prior local treatment of cutaneous marker lesions unless there was</div>\n<div>\n evidence of a clear-cut progression of the lesion.</div>\n<div>\n h. Receipt of any investigational therapy within 30 days prior to study entry.</div>\n<div>\n i. Current or anticipated receipt of any of the prohibited medications indicated</div>\n<div>\n in the protocol under section 5.4.2.</div>\n<div>\n j. In the opinion of the site investigator, any psychological or social condition,</div>\n<div>\n or addictive disorder that would preclude compliance with the protocol.</div>\n<div>\n k. Current chronic, acute, or recurrent infections that are serious, in the opinion</div>\n<div>\n of the site investigator, for which the participant has not completed at least 14</div>\n<div>\n days of therapy prior to study entry and/or is not clinically stable.</div>\n<div>\n Step 2 exclusion criteria:</div>\n<div>\n a. Current chronic, acute, or recurrent infections that are serious, in the opinion</div>\n<div>\n of the site investigator, for which the participant has not completed at least 14</div>\n<div>\n days of therapy prior to initiating ET and/or is not clinically stable.</div>\n<div>\n b. Current or anticipated receipt of any of the prohibited medications indicated</div>\n<div>\n in the protocol under section 5.4.2.</div>\n<div>\n c. Breastfeeding.</div>\n
      • primary_end_points<div>\n Rationale for Primary Endpoint</div>\n<div>\n The primary endpoint will be a composite endpoint of KS tumor response, KS</div>\n<div>\n progression, initiation of a new chemotherapy agent other than ET, and lost to follow-up</div>\n<div>\n (including death). The outcome variable is an ordinal response. The worst outcome is E1</div>\n<div>\n (Failure): disease progression as evidenced by tumor progression at week 48 compared</div>\n<div>\n to baseline or need for initiation of a new chemotherapy regimen other than ET, by week</div>\n<div>\n 48. In addition, participants who die or are lost-to-follow-up will be included in this group.</div>\n<div>\n The middle outcome is E2 participants with stable KS (i.e., no improvement and no</div>\n<div>\n progression) at week 48. The best outcome is E3 (Response) participants who have</div>\n<div>\n demonstrated regression or resolution of KS at week 48.</div>\n<div>\n A 48-week endpoint was chosen to allow a period off chemotherapy for most participants</div>\n<div>\n prior to the primary endpoint to allow for the possibility of worsening disease after</div>\n<div>\n discontinuing chemotherapy. It also allows ample time for participants on ART alone to</div>\n<div>\n mount an immune response against KSHV sufficient to cause tumor regression. The</div>\n<div>\n ordinal endpoint was chosen because having stable KS is clearly better than having KS</div>\n<div>\n progression, but cannot be viewed as a complete treatment success.</div>\n<div>\n 30 A5264/AMC067</div>\n<div>\n FINAL Version 1.0</div>\n<div>\n 08/04/10</div>\n<div>\n Prospective studies on the response of T0 KS cases treated with ART alone in the</div>\n<div>\n resource-limited setting are not available. Based on input from A5264/AMC067 site</div>\n<div>\n investigators we estimate that 30% of participants with T0 KS treated with ART alone or</div>\n<div>\n with delayed initiation of ET will have KS tumor progression compared to baseline at</div>\n<div>\n week 48 and 70% will not [3]. Based on observations from KS clinical care in Uganda</div>\n<div>\n (Jackson Orem, personal communication), we estimate that in participants treated with</div>\n<div>\n ART alone or those who have delayed initiation of ET, 40% will be stable and 30% will</div>\n<div>\n have at least partial response at week 48.</div>\n<div>\n Rationale for Secondary Endpoints</div>\n<div>\n Even though the planned primary endpoint will analyze treatment response at 48 weeks,</div>\n<div>\n A5264/AMC067 is designed to obtain follow-up data to 96 weeks in each participant.</div>\n<div>\n Follow-up to 96 weeks will allow assessment of the durability of treatment response and</div>\n<div>\n will provide assessment of delayed treatment responses that might occur between</div>\n<div>\n weeks 48 and 96. Individuals randomized to Arm 1A (ART only) may experience KS</div>\n<div>\n progression at a variable time after starting protocol treatment and thus may then have</div>\n<div>\n ET added to their regimen at variable times. Participants who initiate ET may then be</div>\n<div>\n treated with up to eight 2-week cycles of chemotherapy. Following participants for 96</div>\n<div>\n weeks will allow adequate time to evaluate the response to chemotherapy in individuals</div>\n<div>\n in whom such therapy is initiated after 24 or more weeks of ART alone and will permit a</div>\n<div>\n more robust evaluation of response duration in these participants.</div>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • 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 Dr. Elisha Okeyo- MD</p>\n<p>\n Dr. Joan Cain - Oncologist</p>\n<p>\n Dr. Esther Mumbi Makanga- MD</p>\n<p>\n Dr. Victor Mudhune - Pharmacist</p>\n<p>\n Dr. Kevin P. Cain - MD</p>\n<p>\n Dr. Victor Akelo MD</p>\n<p>\n Dr. Kenneth Masamaro - MD</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n it is also conducted in the USA</p>\n
      • other_details_regulatory_notapproved<p>\n KEMRI Scientific Ethics Review Unit 9 SERU) - approval 28th Sept 2015</p>\n
      • other_details_regulatory_approved<p>\n KEMRI - for WRP KERICHO</p>\n<p>\n MOI UNIVERSITY - AMPATH ELDORET</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorEFV/FTC/TDF and ET
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • 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_states12
      • number_of_sites2 more
      • multi_country_listWestern Cape-South Africa, Rio de Janeiro-Brazil,\nBlantyre-Malawi, Durban-South Africa, Kampala-Uganda, Kericho-Kenya,\nLilongwe-Malawi, Harare-Zimbabwe, Eldoret-Kenya, Lima-Peru, Johanesburg-\nSouth Africa)
      • data_monitoring_committeeYes
      • total_enrolment_per_site50
      • total_participants_worldwide468 participants (234 in each Arm of Step 1)
      • 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_male1
      • subjects_healthyNo
      • 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_nameDr. Elisha
      • investigator1_middle_nameOchieng
      • investigator1_family_nameOkeyo
      • investigator1_qualificationMD
      • investigator1_professional_addressKEMRI CDC - 1578 Kisumu
      • investigator1_telephone+254721410654
      • investigator1_emaileokeyo@kemricdc.org
      • organisations_transferred_No
      • number_participants50
      • notification
      • approval_date05-05-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted10-11-2015
      • 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)
      • modified2016-05-23 10:08:52
      • created2015-11-05 11:15:54
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id297
        • application_id446
        • given_nameDr. Victor
        • middle_nameOtieno
        • family_nameMudhune
        • qualificationBpharm, MPH
        • professional_addressKEMRICDC 1578 Kisumu
        • telephone0722687430
        • emailvmudhune@kemricdc.org
        • created2015-11-05 14:54:01
        • modified2015-11-10 12:09:56
    • SiteDetail(array)
      • 0(array)
        • id356
        • application_id446
        • county_id42
        • site_nameKEMRI CDC
        • physical_addressKEMRI CDC CLINICAL RESEARCH CENTRE
        • contact_details1578, KISUMU 40100
        • contact_personDR. VICTOR MUDHUNE
        • site_capacity(null)
        • misc(null)
        • created2015-11-05 14:54:01
        • modified2015-11-10 12:09:56
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id232
        • application_id446
        • sponsorThe National Institute of Allergy and Infectious Diseases (NIAID) National Cancer Institute (NCI) National Institute of Dental Craniofacial Research (NIDCR)
        • sponsor_type(null)
        • contact_personThomas B. Campbell, M.D.
        • addressUniversity of Colorado Denver Box B-168 12700 E. 19th Avenue Aurora, CO 80045
        • telephone_numberPhone: (303) 724-4929
        • fax_number
        • cell_numberPhone: (303) 724-4929
        • email_addressThomas.Campbell@ucdenver.edu
        • created2015-11-05 14:54:01
        • modified2015-11-10 12:09:56
  • 2(array)
    • Application(array)
      • id420
      • user_id294
      • trial_status_id6
      • abstract_of_study<p>\n An estimated 3.5 million deaths occur annually in children less than 5 years of age in sub-Saharan Africa, approximately 70% of which are due to infectious causes. One-year mortality rates as high as 15% have been documented following hospital discharge in sub-Saharan Africa, a rate that is 8-fold higher than non-hospitalized children. Children being discharged from hospital in Africa may represent an accessible high-risk population in which to target interventions to reduce mortality.</p>\n<p>\n A recent trial of mass drug administration of azithromycin reduced childhood mortality by half among children in Ethiopia in communities receiving the intervention. However, concerns about the potential for the emergence of antimicrobial resistance, possible toxicity, and the feasibility of delivery are all barriers to community-wide distribution of antibiotics.</p>\n<p>\n We propose a randomized, double-blind, placebo-controlled trial of a 5-day course of azithromycin in children age 1 to 59 months discharged from Kisii Teaching  and Homabay county Referral hospitals in Western Kenya to reduce post-discharge re-hospitalizations and mortality, to explore possible mechanisms by which azithromycin has benefit and risk, and to identify correlates and intermediate markers of re-hospitalization and death in the post-discharge period.</p>\n<p>\n <strong>The proposed study will examine a pragmatic post-discharge intervention that could be used in low resource settings to lower mortality and re-hospitalization rates in high-risk children.  In addition the trial will also explore a number of scientific questions including the effect of antibiotics on enteric and nasopharyngeal infections, inflammation, and the causes of post-discharge mortality. Kisii and Homabay counties are the ideal areas in Western Kenya  to test this intervention because the child mortality rate is high in Nyanza province yet the health facilities in which this study will be conducted have established pediatric research infrastructure</strong>.  </p>\n
      • study_title<p align=\"center\">\n <strong>Azithromycin (AZM) to prevent post-discharge </strong></p>\n<p align=\"center\">\n <strong>morbidity and mortality in Kenyan children</strong></p>\n
      • laymans_summary<p>\n <br />\n Deaths in children have been decreasing worldwide, due in part to the use of antibiotics for illnesses caused by common bacteria. However, bacteria are increasingly becoming resistant to antibiotics, which heightens the risk of treatment failure and death. In order to inform antibiotic prescribing policy it is necessary to know the types of antibiotic resistance in bacteria present in individuals. Due to the spread of resistance between close contacts it is also important to understand the genetic mechanisms of resistance in order to better interpret how bacteria are acquiring resistance. Information on the presence of antibacterial resistance is lacking in Sub-Saharan Africa and is non-existent in children who have previously been hospitalized, a group with a high risk of death in the months following hospitalization. We plan to examine bacteria previously isolated from the stool of recently hospitalized children for genes that suggest resistance to antibiotics used to treat common illnesses in Africa. We will compare the likelihood of resistance in groups of children defined by age, nutritional status, and length of hospital stay to better understand which children are at highest risk and should be targeted for interventions to prevent antibiotic resistance. We will also compare resistance genes between caregivers and children and between bacteria within the same stool sample. This information will help to understand how antibiotic resistance is transmitted between and within individuals</p>\n
      • short_titleAZM
      • protocol_noECCT/15/10/04
      • version_no27Aug2015
      • date_of_protocol27-08-2015
      • study_drugAzithromycin
      • disease_conditionthe effect of antibiotics on enteric and nasopharyngeal infections, inflammation, and the causes of post-discharge mortality and re hospitalization.
      • 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_nameAzithromycin (Zithromax)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssingabo2008@gmail.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_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi0
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantBenson Singa
      • declaration_date128-10-2015
      • declaration_principal_investigatorBenson Singa
      • declaration_date228-10-2015
      • placebo_presentYes
      • study_objectives<p>\n  </p>\n<h1>\n OBJECTIVES</h1>\n<p>\n  </p>\n<p>\n Overall objective: To establish the burden, risk factors, and potential sharing of antibiotic resistance determinants in bacterial isolates from children recently discharged from hospital. Specifically, we aim to:</p>\n<p>\n  </p>\n<p style=\"margin-left:54.0pt;\">\n Objective 1: Establish the burden of clinically and epidemiologically important molecular markers of ESBL (<em>bla</em>_CTX-M,<em>bla</em>_TEM, <em>bla</em>_SHV, bla_OXA,<em>ampC</em>) and macrolide (<em>mef</em>(A), <em>erm</em>(B), <em>erm</em>(C), <em>mph</em>(A)) resistance in commensal <em>E. coli</em> from children at hospital discharge and in a subset of their caregivers.</p>\n<p style=\"margin-left:54.0pt;\">\n  </p>\n<p style=\"margin-left:72.0pt;\">\n <em>Hypothesis: At hospital discharge, children and their caregivers will have a high prevalence of ESBL as determined by presence of any one of the molecular markers mentioned. Macrolide resistance, as determined by presence of mef(A), erm(B),</em><em> erm(C), or mph(A)</em><em> will be less common. Caregivers of children with ESBL and macrolide resistance genes in commensal E. coli will be more likely to have similar resistance gene patterns in their own commensal E. coli. </em></p>\n<p>\n  </p>\n<p style=\"margin-left:54.0pt;\">\n Objective 2: Determine host, clinical, and environmental correlates of molecular markers of ESBL and macrolide resistance in commensal <em>E. coli</em> from children at hospital discharge.</p>\n<p style=\"margin-left:54.0pt;\">\n  </p>\n<p style=\"margin-left:72.0pt;\">\n <em>Hypothesis: Shared correlates of ESBL and macrolide resistance in commensal E. coli of discharged children will include age less than 1-year, malnutrition, and 4-day or longer hospital stay. β-lactam and macrolide use during the hospital stay will be associated with ESBL and macrolide resistance, respectively, in E. coli. </em></p>\n<p>\n  </p>\n<p style=\"margin-left:54.0pt;\">\n Objective 3: Determine the concordance of molecular markers of ESBL and macrolide resistance in commensal <em>E. coli</em> to those in <em>Salmonella</em> or <em>Shigella</em> isolated from the same child.</p>\n<p style=\"margin-left:22.5pt;\">\n  </p>\n<p style=\"margin-left:72.0pt;\">\n <em>Hypothesis: Among children and caregivers with E. coli and either Salmonella or Shigella isolated from stool samples, resistance patterns in E. coli will be at least 80% concordant to resistance patterns in either Salmonella or Shigella. </em></p>\n
      • principal_inclusion_criteria<p>\n Children (age 1-59 months) admitted to hospital for non-trauma conditions and subsequently discharged who plan to remain in study area for at least 6 months</p>\n
      • principal_exclusion_criteria<p>\n Contraindication to azithromycin use (the use of another macrolide antibiotic [i.e. erythromycin or clarithromycin])  or known macrolide allergy. </p>\n
      • primary_end_points<p>\n Rates of  re-hospitalization and mortality .</p>\n<p>\n Risk of antimicrobial resistance. </p>\n<p>\n Cost-effectiveness</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety0
      • 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_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The facilities are county teaching and Referral Hospitals, which are equiped to manage emergencies with the below listed Qualified and licenced professionals involved directly to the AZM Study.</p>\n<p>\n 2.  Paediatricians</p>\n<p>\n 1 study coordinator</p>\n<p>\n 2 Clinical officers</p>\n<p>\n 2. Lab technologists</p>\n<p>\n 2. study counsellors</p>\n
      • other_details_explanation<p>\n Not Applicable, PI in kenya</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n 1. University of Washington, Institution Review Board (IRB), Approved August 21, 2015</p>\n<p>\n 2. Kenya Medical Research Institute, Scientific and Ethics Unit ( SERU) Approved September 08, 2015</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration36 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_comparatorPlacebo
      • design_controlled_other_medicinalYes
      • 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_countriesNo
      • multiple_member_states
      • number_of_sitesTwo
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site700 children and 150 contact adults
      • total_participants_worldwide1700
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • 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_specify*Patients: Children who were recently discharged (but still in hospital facility). \n*Unable to consent: Children under five who are unable to comprehend consent (but caregiver will consent on their behalf)
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBenson
      • investigator1_middle_name
      • investigator1_family_nameSinga
      • investigator1_qualificationMBChB, MPH
      • investigator1_professional_addressKEMRI P.O Box 2651-00200
      • investigator1_telephone0725234844
      • investigator1_emailsingabo2008@gmail.com
      • organisations_transferred_No
      • number_participants1400 children and 300 contact adults
      • notification<p>\n NONE</p>\n
      • approval_date09-02-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-02-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n <strong>Background</strong> Mass drug administration of azithromycin to children in sub-Saharan Africa has been shown to improve survival in high-mortality settings. The period after hospital discharge is a time of elevated risk unaddressed by current interventions and might provide an opportunity for targeting empirical azithromycin administration. We aimed to assess the efficacy of azithromycin administered at hospital discharge on risk of death and re-hospitalization in Kenyan children younger than 5 years.</p>\n<p>\n <strong>Methods</strong> In this double-blind, placebo-controlled randomized trial, children were randomly assigned (1:1) to receive a 5-day course of azithromycin (oral suspension 10 mg/kg on day 1, followed by 5mg/kg per day on days 2–5) or identically appearing and tasting placebo at discharge from four hospitals in western Kenya. Children were eligible if they were aged 1–59 months at hospital discharge, weighed at least 2 kg, and had been admitted to hospital for any medical reason other than trauma, poisoning, or congenital anomaly. The primary outcome was death or re-hospitalization in the subsequent 6-month period in a modified intention-to-treat population, compared by randomization group with Cox proportional hazards regression and Kaplan-Meier. Azithromycin resistance in <em>Escherichia coli</em> isolates from a random subset of children was compared by randomization group with generalized estimating equations. This trial is registered with ClinicalTrials.gov, NCT02414399.</p>\n<p>\n <strong>Findings</strong> Between June 28, 2016, and Nov 4, 2019, 1400 children were enrolled in the trial at discharge from hospital, with 703 (50·2%) randomly assigned to azithromycin and 697 (49·8%) to placebo. Among the 1398 children included in the modified intention-to-treat analysis (702 in the azithromycin group and 696 in the placebo group), the incidence of death or re-hospitalization was 20·4 per 100 child-years in the azithromycin group and 22·5 per 100 child-years in the placebo group (adjusted hazard ratio 0·91, 95·5% CI 0·64–1·29, p=0·58). Azithromycin resistance was common in commensal <em>E coli</em> isolates from enrolled children before randomization (37·7% of 406 isolates) despite only 3·7% of children having received a macrolide antibiotic during the hospitalization. Azithromycin resistance was slightly higher at 3 months after randomization in the azithromycin group (26·9%) than in the placebo group (19·1%; adjusted prevalence ratio 1·41, 95% CI 0·95–2·09, p=0·088), with no difference observed at 6 months (1·17, 0·78–1·76, p=0·44).</p>\n<p>\n <strong>Interpretation</strong> We did not observe a significant benefit of a 5-day course of azithromycin delivered to children younger than 5 years at hospital discharge despite the overall high risk of mortality and re-hospitalization.These findings highlight the need more research into mechanisms and interventions for prevention of morbidity and mortality in the post-discharge period.</p>\n
      • implication_results<p>\n The high rates of re-hospitalization and death observed in the trial underscore the critical importance of the post-discharge period to child health, and the need to develop new interventions or follow-up strategies to improve recovering in this critical period.</p>\n
      • quantity_imported2332
      • quantity_dispensed1400
      • quantity_destroyed932
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2022-06-28 15:15:28
      • created2015-09-22 12:13:13
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id286
        • application_id420
        • given_nameJudd Walson
        • middle_name
        • family_nameWalson
        • qualificationB.A, M.D, M.P.H.
        • professional_addressUniversity of Washington 325 9th Avenue ,Box 359909. Seattle, WA 98104
        • telephone(206)543-4278
        • emailwalson@u.washington.edu
        • created2015-09-22 12:25:32
        • modified2020-02-24 08:53:55
    • SiteDetail(array)
      • 0(array)
        • id339
        • application_id420
        • county_id43
        • site_nameHoma Bay County referral Hospital
        • physical_addressGovernors Road
        • contact_detailsP.O BOX 52- 40300
        • contact_personThe medical Superintendent
        • site_capacity(null)
        • misc(null)
        • created2015-09-22 12:25:32
        • modified2020-02-24 08:53:55
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 1(array)
        • id340
        • application_id420
        • county_id45
        • site_nameKisii Teaching and referral Hospital
        • physical_addressHospital Road P.O BOX 92-40200 Kisii
        • contact_detailsinfo@ktrh.or.ke
        • contact_personThe medical Superintendent
        • site_capacity(null)
        • misc(null)
        • created2015-09-23 11:06:56
        • modified2020-02-24 08:53:55
        • County(array)
          • id45
          • county_nameKisii
          • created2012-06-15 10:27:25
          • modified2012-06-15 10:27:25
    • Sponsor(array)
      • 0(array)
        • id223
        • application_id420
        • sponsorNational Institute of Health
        • sponsor_typeResearch Institution
        • contact_personDenise Russo (Deputy, Maternal and Pediatric Infectious Disease Branch)
        • address6100 Executive Boulevard, Room 4B11E Rockville, MD 20852
        • telephone_number301-435-6871
        • fax_number
        • cell_number301-435-6871
        • email_addressdrusso1@mail.nih.gov
        • created2015-09-22 12:25:32
        • modified2020-02-24 08:53:55
  • 3(array)
    • Application(array)
      • id412
      • user_id73
      • trial_status_id5
      • abstract_of_study<p>\n The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term HIV-1 serodiscordant partnerships, i.e. where one partner is HIV-1 infected and the other uninfected. Heterosexual HIV-1 serodiscordant couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Pregnancy rates among HIV-1 serodiscordant couples are similar to the general population and we have learned from our clinical trial cohorts and qualitative data collection that fertility desires often outweigh HIV-1 risks for these couples and they make conscientious decisions to increase sexual frequency and reduce condom use in order to conceive. Thus, there is a critical need to test the feasibility and acceptance of a “safer conception” intervention for low resource settings, an integrated biomedical and behavioral approach to minimize HIV-1 risk when serodiscordant couples are intending to become pregnant. In the absence of such an intervention, couples will continue to attempt pregnancy, but they will do so with greater HIV-1 transmission risk than necessary.</p>\n<p>\n Based on evidence from rigorous clinical trials demonstrating the strong efficacy of individual interventions  for HIV-1 prevention and formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1 prevention and reproductive health in the Kenyan context, we will pilot a safer conception intervention that focuses on antiretrovirals (as antiretroviral therapy [ART] taken by the HIV-1 infected partner and pre-exposure prophylaxis [PrEP] taken by the HIV-1 uninfected partner) and timed condomless sex.  Additional strategies for couples will include diagnosis and treatment of STIs and male circumcision. The Figure below presents a schematic of the safer conception components that will be incorporated.</p>\n<p>\n mHealth tools, including SMS and tablet applications, are novel and very popular among Kenyans to ease the burden of addressing health problems.  Our safer conception intervention will incorporate mHealth tools to improve couples’ experiences tracking fertility indicators and communicating with providers about their readiness to practice safer conception.  An SMS survey will be used to collect daily information from women about their fertility signs and SMS messages will be used to reinforce HIV-1 prevention, including condom use for couples during periods that do not have a high likelihood of fertility. An in-clinic tablet application will be used to improve clinician-patient counseling and assessments of couple readiness to practice safer conception. To inform future engagement of mHealth tools, will prospectively evaluate clinician and patient experiences using SMS surveys and the tablet application.</p>\n<p>\n This work will take place at the Partners in Health Research and Development site in Thika, Kenya, where the clinical research staff are experts in working with HIV-1 serodiscordant couples since the site inception in 2006.  Couples with immediate fertility intentions and a high likelihood to become pregnant within one year – determined by using a validated, empiric scoring tool that we have developed – will be followed longitudinally, allowing careful tracking of pregnancy and HIV-1 incidence.  This is the exact outcome that HIV-1 prevention programs need to monitor to ensure that we fully understand the preferences and willingness of couples to practice safer conception and the ability of an integrated intervention to reduce HIV-1 transmission risk to the lowest level possible during peri-conception periods.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Pilot of an mHealth-enhanced, safer conception intervention to reduce HIV-1 risk among Kenyan HIV-1 serodiscordant couples</strong></p>\n<p align=\"center\">\n <strong><em>Safer Conception Intervention for Partners (SCIP)</em></strong></p>\n
      • laymans_summary(null)
      • short_titleSafer Conception Intervention for Partners (SCIP)
      • protocol_noECCT/15/10/03
      • version_no3.0
      • date_of_protocol08-09-2015
      • study_drugEmtricitabine/Tenofovir or Tenofovir Disoproxil Fumarate (SCIP Study)
      • disease_conditionPrEP as a \'\'Safer Conception Tool\'\'
      • 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_nameEmtricitabine/Tenofovir or Tenofovir Disoproxil Fumarate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.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. Kenneth Ngure
      • declaration_date122-10-2015
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date222-10-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p style=\"margin-left:1.0in;\">\n <u>For couples</u></p>\n<ul>\n <li>\n Immediate fertility intention and a high likelihood of pregnancy</li>\n <li>\n Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)</li>\n <li>\n Willing to enter the study as a couple and intending to remain as a couple for the next 12 months</li>\n <li>\n Did not participate in the Partners PrEP Study or the Partners Demonstration Project</li>\n</ul>\n<p>\n <u>For HIV-1 infected members of the couple (index participants)</u></p>\n<ul>\n <li>\n Age ≥18</li>\n <li>\n If female, not older than age 49</li>\n <li>\n Able and willing to provide written informed consent</li>\n <li>\n HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm</li>\n <li>\n Not currently pregnant or breastfeeding</li>\n <li>\n No use of injectable contraception for the past 3 months</li>\n <li>\n Not currently enrolled in an HIV-1 treatment study</li>\n <li>\n No clear indication of infertility or subfertility, as determined by medical history</li>\n <li>\n Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 uninfected partner</li>\n <li>\n Know how to send and receive SMS</li>\n <li>\n Have regular access to electricity or an alternative means for charging a cell phone</li>\n <li>\n Literate in English, Kiswahili or Kikuyu</li>\n</ul>\n<p>\n <u>For HIV-1 uninfected members of the couple (partner participants)</u></p>\n<ul>\n <li>\n Age ≥18</li>\n <li>\n If female, not older than age 49</li>\n <li>\n Able and willing to provide written informed consent</li>\n <li>\n HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit</li>\n <li>\n Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min</li>\n <li>\n Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test</li>\n <li>\n Not currently pregnant or breastfeeding  </li>\n <li>\n No use of injectable contraception for the past 3 months</li>\n <li>\n Not currently enrolled in an HIV-1 prevention clinical trial</li>\n <li>\n Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator</li>\n <li>\n No clear indication of infertility or subfertility, as determined by medical history</li>\n <li>\n Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 infected partner</li>\n <li>\n Know how to send and receive SMS</li>\n <li>\n Have regular access to electricity or an alternative means for charging a cell phone</li>\n <li>\n Literate in English, Kiswahili or Kikuyu</li>\n</ul>\n<p>\n <u>For study clinicians and counselors</u></p>\n<ul>\n <li>\n Active involvement in safer conception counseling for couples and use of the tablet application during counseling sessions</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n Contrary to any of the Inclusion criteria.</p>\n<p>\n Having taken part in Partners PrEP Study or the Partners Demonstration Project.</p>\n
      • primary_end_points<p>\n Pregnancy using the safer conception tools.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Site Coordinator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Lead Physician for the study: Dr. Njambi Njuguna  MBChB, MSc, MPH</p>\n
      • other_details_explanation<p>\n The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term HIV-1 serodiscordant partnerships, i.e. where one partner is HIV-1 infected and the other uninfected. Heterosexual HIV-1 serodiscordant couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Pregnancy rates among HIV-1 serodiscordant couples are similar to the general population and we have learned from our clinical trial cohorts and qualitative data collection that fertility desires often outweigh HIV-1 risks for these couples and they make conscientious decisions to increase sexual frequency and reduce condom use in order to conceive. Thus, there is a critical need to test the feasibility and acceptance of a “safer conception” intervention for low resource settings, an integrated biomedical and behavioral approach to minimize HIV-1 risk when serodiscordant couples are intending to become pregnant. In the absence of such an intervention, couples will continue to attempt pregnancy, but they will do so with greater HIV-1 transmission risk than necessary.</p>\n
      • other_details_regulatory_notapproved<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n University of Washington Institutional Review Board (UW IRB)</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Submission will be done before end of October 2015</p>\n
      • other_details_regulatory_approved<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Kenya Medical Research Institute's (KEMRI) Scientific, Ethics and Research Unit (SERU)</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n                     Approved on 5th October 2015.</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration3 Years
      • 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_areaThika Partners Study Clinic (Partners in Health Research and Development) affiliated to the University of Washington International Clinical Research Center (ICRC), and KEMRI
      • single_site_physical_addressOAU Road, Near Thika Nursing home - Thika section 9
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone067-22561
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site80 couples\nStudy clinicians and counselors delivering the intervention
      • total_participants_worldwide80 couples, Study clinicians and counselors delivering the intervention
      • 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_nameRenee
      • investigator1_middle_name
      • investigator1_family_nameHeffron
      • investigator1_qualificationMPH, PhD
      • investigator1_professional_addressUniversity of Washington, Seattle
      • investigator1_telephone+1 2065203817
      • investigator1_emailrheffron@uw.edu
      • organisations_transferred_Yes
      • number_participants80 couples\nStudy clinicians and counselors delivering the intervention
      • notification
      • approval_date11-01-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-10-2015
      • 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)
      • modified2018-08-02 11:46:04
      • created2015-08-06 11:19:28
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id280
        • application_id412
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone0723 914057
        • emailrwamba@csrtkenya.org
        • created2015-08-06 11:20:52
        • modified2015-10-22 10:45:47
    • SiteDetail(array)
      • 0(array)
        • id333
        • application_id412
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-08-06 11:20:52
        • modified2015-10-22 10:45:47
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id218
        • application_id412
        • sponsorUniversity of Washington
        • sponsor_type(null)
        • contact_personDr. Nelly Rwamba Mugo
        • addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone_number067-22561
        • fax_number
        • cell_number0723 914057
        • email_addressrwamba@csrtkenya.org
        • created2015-08-06 11:20:52
        • modified2015-10-22 10:45:47
  • 4(array)
    • Application(array)
      • id431
      • user_id302
      • trial_status_id(null)
      • abstract_of_study<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 100%;\" width=\"100%\">\n <tbody>\n <tr>\n <td style=\"width: 23.8%;\">\n <p align=\"left\">\n <strong>Data analysis</strong></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 <p>\n  </p>\n <p align=\"center\">\n  </p>\n </td>\n <td style=\"width: 76.2%;\">\n <p>\n Data Analysis: PK parameters:</p>\n <p>\n The disposition of Captopril following oral administration will be characterized according to the following equation for a one compartment model with an absorption phase and an elimination phase: C_p = (F.D/V)[Ka/(Ka-K)[ {exp[-K(t-t_lag)], where F is the fraction of administered dose which is bioavailable, D is the administered dose, V is the apparent volume of distribution, and the other terms are as defined above . The PK data fitting program Phoenix WinNonlin (Version 6.2 or higher), or a suitable alternative, will be used to fit the data according to this equation.</p>\n <p>\n The following PK parameters will be calculated:</p>\n <ul>\n <li>\n AUC_last will be calculated using the linear  trapezoidal rule</li>\n <li>\n AUC_inf will be estimated as the sum of AUC_last and the terminal area determined from C_last/T_last.</li>\n <li>\n C_max, and T_max, will be observed maximum drug concentration and the corresponding times, respectively</li>\n <li>\n T1/2 will be estimated from the terminal elimination phase drug concentration-time date using standard PK procedures. Data will be summarized as mean [95% confidence interval) except for age, C_max and T_max, which will be expressed as median (range).</li>\n </ul>\n <p>\n Safety parameters:</p>\n <p>\n Descriptive statistics of subjects’ safety data will be carried out. The number and percentage of subjects with adverse events will be tabulated by system organ class and preferred term.</p>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • study_title<p>\n A non-randomized, open label, single dose, pharmacokinetics, safety and tolerability study of Captopril 50mgs in healthy Kenyan Adults.</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/10/02
      • version_noV3
      • date_of_protocol17-08-2015
      • study_drugCaptopril
      • disease_conditionHypertension
      • 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_namecaptopril
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressbernhards.ogutu@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)
      • 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. Bernhards Ogutu
      • declaration_date114-10-2015
      • declaration_principal_investigatorDr. Bernahrds Ogutu
      • declaration_date214-10-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Obtained written informed consent.</li>\n <li>\n Adult male and female(non-child bearing potential) subjects 18 to 45 years of age old, weighing at least 50 kg ,  with  a body mass index (BMI) within the range of 18-30 kg/m² and in good health as determined by past medical history, physical examination, vital signs, and laboratory tests at screening, will be included.</li>\n</ul>\n<ul>\n <li>\n Able to communicate well with the investigator and to understand and comply with the requirements of the study.</li>\n <li>\n Minimum of Four education qualification</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Use of Captopril or any other ACE inhibitor at the time of enrollment, or within 5 half-lives of enrollment.</li>\n <li>\n Known history of hypersensitivity to Captopril or (ACE) inhibitors.</li>\n <li>\n Known medical history of hereditary/idiopathic angioneurotic edema.</li>\n <li>\n History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.</li>\n</ul>\n<ul>\n <li>\n Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation. Pregnancy is confirmed by a positive pregnancy test.</li>\n <li>\n Donation or loss of 450 mL or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.</li>\n <li>\n Significant illness which has not resolved within two (2) weeks prior to initial dosing.</li>\n <li>\n Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.</li>\n <li>\n History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening and/or baseline.</li>\n <li>\n Refusal to give Informed Consent.</li>\n</ul>\n
      • primary_end_points<p>\n The following PK parameters will be calculated:</p>\n<ul>\n <li>\n AUC_last will be calculated using the linear  trapezoidal rule</li>\n <li>\n AUC_inf will be estimated as the sum of AUC_last and the terminal area determined from C_last/T_last.</li>\n <li>\n C_max, and T_max, will be observed maximum drug concentration and the corresponding times, respectively</li>\n <li>\n T1/2 will be estimated from the terminal elimination phase drug concentration-time date using standard PK procedures. Data will be summarized as mean [95% confidence interval) except for age, C_max and T_max, which will be expressed as median (range).</li>\n</ul>\n<p>\n Safety parameters:</p>\n<p>\n Descriptive statistics of subjects’ safety data will be carried out. The number and percentage of subjects with adverse events will be tabulated by system organ class and preferred term.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic1
      • 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  The centre has a 28 bed ward capacity with clinical laboratory for safety evelautaion, pharmacy for clinical trials, emergency room, patient examination rooms, radiology unit, archives, kitchen, laundry, data management room, offices.</p>\n<p>\n Key staff for the study</p>\n<p>\n 1. Dr. Bernhards Ogutu, MMed (paeds), PhD (clinical pharmacology)  - 20 years clinical trials experience</p>\n<p>\n 2. Dr. Elizabeth Juma, MMed (obs/gyn), MPH, 10 years clinical trials experience</p>\n<p>\n 4. Dr. Kevin Omondi , MBChB, - Years clinical trials Experience</p>\n<p>\n 5. Dr. Andrew Omandi Cole MBChB, - 3 years clinical trials experience</p>\n<p>\n 5. Ms. Charity Maingi, KRN, Msc, clinical research coordinator, 8 years clinical trials experience</p>\n<p>\n  </p>\n<p>\n 12 lab techs and 16 nurses who have GCP training. </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n Pharmacy and Poisons Board, Kenya</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration1 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 centre for clinical Research
      • single_site_physical_addressMbagathi way, P.O.Box 54840 -0200 Nairobi
      • single_site_contact_personBernhards Ogutu
      • single_site_telephone0733812613
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site20
      • total_participants_worldwide20
      • 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_nameBernhards
      • investigator1_middle_nameRagama
      • investigator1_family_nameOgutu
      • investigator1_qualificationMBChB, MMed, PhD
      • investigator1_professional_addressP.O.Box 2254 Nairobi
      • investigator1_telephone0733812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_No
      • number_participants20
      • notification
      • approval_date02-12-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted21-10-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
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      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2015-12-02 12:36:31
      • created2015-10-14 16:21:15
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id289
        • application_id431
        • given_nameBernhards
        • middle_nameRagama
        • family_nameOgutu
        • qualificationMBChB, MMed, Phd
        • professional_addressP.O.Box 2254 Nairobi
        • telephone0733812613
        • emailogutu@gmail.com
        • created2015-10-14 16:57:33
        • modified2015-10-21 11:46:35
    • SiteDetail(array)
      • 0(array)
        • id345
        • application_id431
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-10-14 16:57:33
        • modified2015-10-21 11:46:35
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id226
        • application_id431
        • sponsorPI
        • sponsor_type(null)
        • contact_person
        • addressP.O.Box 2254
        • telephone_number0733812613
        • fax_number
        • cell_number0733812613
        • email_addressogutu6@gmail.com
        • created2015-10-14 16:57:33
        • modified2015-10-21 11:46:35
• page_options(array)
  • 55
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• redir
• $request->data(array)
  • Application(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
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  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
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• 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

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  • Behavior(array)
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    • 1CORE/Model/Behavior/ContainableBehavior.php
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    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
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  • Config(array)
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• plugins(array)
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  • Shim(array)
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  • Tools(array)
    • Config(array)
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