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• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id477
      • user_id316
      • trial_status_id(null)
      • abstract_of_study<p>\n Acute respiratory infections (ARI) are a major cause of child morbidity and mortality globally. Pneumonia in particular is the leading cause of child mortality with developing countries accounting for majority of the deaths. In Kenya 17% of deaths among children below five years were caused by pneumonia. A total of 534,863 new cases of childhood pneumonia were registered in the year 2013 alone. The World Health Organization (WHO) recommends using respiratory rate cut-offs for diagnosis and classification of pneumonia in low-resource settings where chest radiology or blood tests are largely unavailable.  Accurate respiratory rate counting is thus critical in determining the subsequent management of childhood pneumonia. Therefore, it is crucial to improve ways of counting the respiratory rate. Having a better and more reliable device for accurate respiratory rate count is important for diagnosis and management of pneumonia in children. The Philips Research Group has developed an automated pneumonia diagnostic device named as “Children’s Automated Respiration Monitor (ChARM)”.The device automatically measures the respiratory rate and classifies according to the current WHO guidelines. This study aims at assessing the accuracy, usability and acceptability of the device as a step towards recommending it for large scale public use in the management of pneumonia in children.</p>\n
      • study_title<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>ASSESSING </strong><strong>THE ACCURACY, USABILITY AND ACCEPTABILITY OF CHILDREN’S AUTOMATED RESPIRATORY MONITOR AT SELECTED CLINICS IN  TURKANA COUNTY, KENYA ‘</strong></p>\n<p>\n <br />\n  </p>\n
      • laymans_summary(null)
      • short_titleASSESSING THE ACCURACY, USABILITY AND ACCEPTABILITY OF CHILDREN’S AUTOMATED RESPIRATORY MONITOR AT SELECTED CLINICS IN TURKANA COUNTY, KENYA ‘
      • protocol_noECCT/16/02/01
      • version_no7.0,
      • date_of_protocol10-12-2015
      • study_drugdevice for respiratory measurement
      • disease_conditionpneumonia
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_namenot applicable
      • product_type_medical_device_nameChild automated respiratory monitori
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressisaiahmwangi@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_countries1
      • 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 ISAIAH MWANGI
      • declaration_date102-02-2016
      • declaration_principal_investigatorDR RASHID SHAH
      • declaration_date202-02-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Child <5 years of age who will be attending Lodwar county hospital, Turkana county in Kenya will be eligible for the accuracy aspect of the study.</li>\n <li>\n Parents/caregivers of a recruited child  stated above will be eligible for the acceptability aspect of the study</li>\n <li>\n Health care provider in the participating health facilities will be eligible for usability and quality of care aspects of the study.</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Child <5 years of age who will be attending Lodwar county hospital, Turkana county in Kenya will be eligible for the accuracy aspect of the study.</li>\n <li>\n Parents/caregivers of a recruited child  stated above will be eligible for the acceptability aspect of the study</li>\n <li>\n Health care provider in the participating health facilities will be eligible for usability and quality of care aspects of the study.</li>\n</ol>\n
      • primary_end_points<p>\n TOTAL RECRUITS REACH 120</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_specifyMEICAL DEVICE
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyDEVICE
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n RESEARCH ASSISTANT</p>\n<p>\n STUDY CO ORDINATOR</p>\n<p>\n LIAISON PERSON</p>\n
      • other_details_explanation<p>\n This device is meeant for poor resource countries and Kenya is one of them</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n SAVE THE CHILDREN,S FUND USA</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration3 MONTHS
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites1
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site120
      • total_participants_worldwide120
      • 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_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
      • investigator1_middle_name
      • investigator1_family_nameSHAH
      • investigator1_qualificationPHD
      • investigator1_professional_addressKENYA MEDICAL RESEARCH INSTITE
      • investigator1_telephone+1 443 683 6236
      • investigator1_emailmshah@savethechildren.org
      • organisations_transferred_Yes
      • number_participants120
      • notification
      • approval_date21-03-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-02-2016
      • 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)
      • modified2016-03-21 19:32:37
      • created2016-02-02 10:02:11
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id319
        • application_id477
        • given_nameISAIAH
        • middle_name
        • family_nameMWANGI
        • qualificationMSC
        • professional_addressKENYA MEDICAL RESEARCH INSTITUTE
        • telephone+ 254 724 568 332
        • emailisaiahmwangi@gmail.com
        • created2016-02-02 10:04:36
        • modified2016-02-18 17:05:15
    • SiteDetail(array)
      • 0(array)
        • id380
        • application_id477
        • county_id23
        • site_namelodwar hospital
        • physical_address po box 20 lodwar
        • contact_detailsTel 0703677168
        • contact_personDave EKWAM
        • site_capacity(null)
        • misc(null)
        • created2016-02-02 10:04:36
        • modified2016-02-18 17:05:15
        • County(array)
          • id23
          • county_nameTurkana
          • created2012-06-15 10:24:43
          • modified2012-06-15 10:24:43
    • Sponsor(array)
      • 0(array)
        • id252
        • application_id477
        • sponsorPHILIPS MEDICAL
        • sponsor_type(null)
        • contact_personPavan Evan
        • addressPHILIPS MEDICAL NETHERLANDS
        • telephone_number+ 41 278 443 9877
        • fax_number
        • cell_number+ 41 278 5569265
        • email_addressinfo@philipsmedical.com
        • created2016-02-02 10:04:36
        • modified2016-02-18 17:05:15
  • 1(array)
    • Application(array)
      • id424
      • user_id32
      • trial_status_id5
      • abstract_of_study<div>\n Background and rationale: Children hospitalised with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge. No strategy specifically addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly 3-day treatment courses of artemether-lumefantrine (AL) in children with severe malarial anaemia prevented 31% of deaths and readmissions. The effect was in addition to the effect of insecticide-treated bednets. These promising findings now need to be confirmed in other settings before the World Health Organisation can consider PMC for the post-discharge management of severe anaemia.</div>\n<div>\n  </div>\n<div>\n Primary efficacy objective: To determine if 3 months of post-discharge malaria chemoprevention with monthly 3-day treatment courses of dihydroartemisinin-piperaquine (DP) (PMC-DP) is safe and superior to the standard single 3-day treatment course with artemether-lumefantrine provided as part of standard in-hospital care in reducing all-cause readmissions and deaths by 6 months in the post-discharge management of children less than 5 years of age admitted with severe anaemia.</div>\n<div>\n  </div>\n<div>\n Hypothesis: An additional three months of malaria chemoprevention with monthly 3-day treatment courses with DHA-piperaquine (each providing about 4 weeks of post-treatment prophylaxis) provided during the post-discharge period to children recently admitted with severe anaemia is superior to reduce all-cause readmission and mortality rates by 6 months compared with 2 weeks of post-treatment prophylaxis provided by the single course of oral artemether-lumefantrine when given as part of the standard in-hospital care around the time of discharge.</div>\n<div>\n  </div>\n<div>\n Study Type: Multi-centre, 2-arm, placebo-controlled, individually randomized, trial of 3 courses of monthly PMC-DP in Uganda and Kenya, using randomisation stratified by age and study centre.</div>\n<div>\n  </div>\n<div>\n Sites: 7 hospitals, 4 in western Kenya and 3 in Uganda, in areas with moderate to intense malaria transmission. The number of hospitals will be expanded if recruitment if so required.</div>\n<div>\n  </div>\n<div>\n Study Population: Inclusion criteria: convalescent children aged less than 5 years and weighing >5 kg admitted with severe anaemia (haemoglobin<5g/dL / Ht<15%); clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL. Exclusion criteria: blood loss due to trauma, malignancy, known bleeding disorders or sickle cell trait, known hypersensitivity to study drug, known heart conditions, non-resident in study area, previous participation in study, known need at enrolment for prohibited medication and scheduled surgery during the 6-month course of the study. HIV infection and cotrimoxazole prophylaxis are not exclusion criteria.</div>\n<div>\n  </div>\n<div>\n Study Interventions: Children in both arms will receive standard in-hospital care for severe anaemia (blood transfusion, often combined with quinine or artesunate IV/IM). All children will then receive a 3-day course of AL (whether they initially had malaria or not), which will be started in-hospital assoon as they are able to take oral medication, and will be completed at home after discharge. At 2 weeks after enrolment surviving children will be randomized to receive either a standard 3-day courses of DP (Duo-Cotecxin®, HolleyCotec) or an identical placebo regimen at 2, 6 and 10 weeks after enrolment.</div>\n<div>\n  </div>\n<div>\n Outcome Measures: Primary: Death or all-cause re-admission between randomisation and 6 months from enrolment (composite primary outcome). Key secondary: 1) all-cause mortality, 2) all-cause hospital readmission, 3) readmissions due to severe anaemia or severe malaria (requiring parenteral quinine or artesunate), 4) non-severe all-cause sick-child clinic visits, 5) clinic visit because of RDT or microscopy confirmed non-severe malaria.</div>\n<div>\n  </div>\n<div>\n Follow-up procedures: Children will be followed for 6 months by passive case detection in 3 phases: Pre-PMC (2 weeks between discharge and randomisation); PMC (2-14 weeks post-discharge); post-PMC (extended follow period from 15 to 26 weeks post-discharge).</div>\n<div>\n Sample size: A sample size of 1106 children per arm (2212 total children) allows detection of a 30% reduction from 17.6% to 12.3% with 10% loss to follow-up (power 90%, α=0.05).</div>\n<div>\n  </div>\n<div>\n Data Analysis: Primary analysis will be by intention to treat, and include all events to capture the potential effect of PMC on reducing first and repeat events. The protective efficacy (95% CI) will be calculated as 100 multiplied by (1–hazard ratio) and covariate-adjusted for prognostic factors at baseline. Incidence rates per child-year and absolute rate reductions will also be calculated. To assess how long any initial beneficial effect of PMC is sustained, the observation time will also be divided into a) PMC period (1-3 months); and b) Extended follow-up period (4–6 months).</div>\n<div>\n  </div>\n<div>\n Partners institutions: University of Bergen; University of Malawi; Makerere University; KEMRI-CDC, Kenya; University of Minnesota; Liverpool School of Tropical Medicine; London School of Hygiene & Tropical Medicine; Imperial College London; University of Amsterdam; US Centers for Disease Control and Prevention, University of North Carolina, and University of Massachusetts.</div>\n
      • study_title<p>\n <span style=\"font-size:12px;\">Malaria Chemoprevention with monthly treatment with dihydroartemisinin-piperaquine for the post-discharge management of severe anaemia in children aged less than 5 years in Uganda and Kenya: A 3-year, multi-centre, parallel-group, two-arm randomised placebo controlled superiority trial</span></p>\n
      • laymans_summary<p>\n N/A</p>\n
      • short_titlePost-discharge Malaria Chemoprevention(PMC) study
      • protocol_noECCT/15/12/05
      • version_no2
      • date_of_protocol27-11-2014
      • study_drugPMC (DHA-Piperaquine)
      • 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_nameDihydroartemisinin-piperaquine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstsang@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)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan1
      • applicant_contractual_agreement0
      • declaration_applicantDr Tony Sang
      • declaration_date115-12-2015
      • declaration_principal_investigatorDr Titus Kwambai
      • declaration_date215-12-2015
      • placebo_presentYes
      • study_objectives<p>\n <u> Primary objective</u></p>\n<ul>\n <li>\n To determine if 3 months of post-discharge malaria chemoprevention with monthly 3-day treatment courses of dihydroartemisinin-piperaquine (DP) (PMC-DP) is safe and superior to the standard single 3-day treatment course with artemether-lumefantrine provided as part of standard in-hospital care in reducing all-cause readmissions and deaths by 6 months in the post-discharge management of children less than 5 years of age admitted with severe anaemia.</li>\n</ul>\n<div>\n  </div>\n<div>\n <u>Secondary objectives</u></div>\n<ul>\n <li>\n To determine the cost-effectiveness of PMC-DP compared to current standard of care.</li>\n</ul>\n
      • principal_inclusion_criteria<div>\n Pre-study screening</div>\n<div>\n 1. Haemoglobin <5.0 g/dl or PCV < 15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital</div>\n<div>\n 2. Aged less than 59.5 months</div>\n<div>\n 3. Body weight >5 kg</div>\n<div>\n 4. Resident in catchment area</div>\n<div>\n  </div>\n<div>\n Enrolment in study (t=0)</div>\n<div>\n 1. Fulfilled the pre-study screening eligibility criteria</div>\n<div>\n 2. Aged < 59.5 months</div>\n<div>\n 3. Clinically stable, able to take oral medication</div>\n<div>\n 4. Subject completed blood transfusion(s) or became clinically stable without transfusion</div>\n<div>\n 5. Able to feed (for breastfeeding children) or eat (for older children)</div>\n<div>\n 6. Absence of know cardiac problems</div>\n<div>\n 7. Provision of informed consent by parent or guardian</div>\n<div>\n  </div>\n<div>\n Randomisation (t=2 weeks)</div>\n<div>\n 1. Fulfilled enrolment eligibility criteria and was enrolled during recent admission</div>\n<div>\n 2. Aged <60 months</div>\n<div>\n 3. Still clinically stable, able to take to oral medication, able to feed (for breastfeeding children) or eat (for older children) and able to sit unaided (for older children who were already able to do so prior to hospitalisation)</div>\n
      • principal_exclusion_criteria<div>\n Pre-study screening</div>\n<ol>\n <li>\n Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder)</li>\n <li>\n Known sickle cell disease</li>\n <li>\n Anticipated to reach the 5th birthday (60 months of age) within 2 weeks from enrolment (i.e. prior to randomization)</li>\n <li>\n Child will reside for more than 25% of the 6 months study period (i.e. 6 weeks or more) outside of catchment area</li>\n</ol>\n<div>\n  </div>\n<div>\n Enrolment in study (t=0)</div>\n<ol>\n <li>\n Previous enrolment in the present study</li>\n <li>\n Known hypersensitivity to study drug</li>\n <li>\n Sickle cell disease</li>\n <li>\n Use or known need at the time of enrolment for concomitant prohibited medication (see section 8.5.7.2, page 34) during the 14 weeks PMC treatment period (see section 8.5.7.2, page 34).</li>\n <li>\n Ongoing or planned participation in another clinical trial involving ongoing or scheduled treatment with prohibited medicinal products or active follow-up during the course of the study (6 months from enrolment)</li>\n <li>\n A known need at the time of enrolment for scheduled surgery during the subsequent course of the study (6 months from enrolment)</li>\n <li>\n Suspected non-compliance with the follow-up schedule</li>\n <li>\n Know heart conditions, or family history of congenital prolongation of the QTc interval.</li>\n <li>\n Taking medicinal products that are known to prolong the QTc interval</li>\n</ol>\n<div>\n <div>\n  </div>\n <div>\n Randomisation (t=2 weeks)</div>\n <ol>\n <li>\n Used DP since enrolment</li>\n <li>\n Use or known need at the time of randomisation for concomitant prohibited medication (see section 8.5.7.2, page 34) during the 14 weeks PMC treatment period (see section 8.5.7.2, page 34).</li>\n <li>\n Enrolled, or known agreement to enrol into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study (6 months from enrolment)</li>\n <li>\n A known need at the time of randomisation for scheduled surgery during the subsequent course of the study (6 months from enrolment)</li>\n <li>\n Suspected non-compliance with the follow-up schedule</li>\n <li>\n Withdrawal of consent since enrolment</li>\n </ol>\n <div>\n  </div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<p>\n Primary Outcome:</p>\n<ol>\n <li>\n All-cause deaths or all-cause re-admissions by 26 weeks from randomization (composite primary outcome)</li>\n</ol>\n<div>\n Key Secondary efficacy outcomes</div>\n<ol>\n <li>\n Readmission due to severe malaria (defined as any treatment with parenteral quinine or artesunate, or presence of severe anaemia and treatment with oral antimalarials) by 26 weeks from randomization</li>\n <li>\n Readmissions due to severe anaemia (defined as Hb <5g/dL or PCV <15% or requirement for blood transfusion based on other clinical indication) by 26 weeks from randomization</li>\n <li>\n Readmission due to severe malarial anaemia (severe anaemia plus parenteral or oral antimalarial treatment) by 26 weeks from randomization</li>\n <li>\n Readmission due to severe anaemia or severe malaria (composite outcome) by 26 weeks from randomization</li>\n <li>\n All-cause mortality by 26 weeks from randomization</li>\n <li>\n All-cause hospital readmission by 26 weeks from randomization</li>\n <li>\n Clinic visits because of smear of RDT confirmed non-severe malaria</li>\n</ol>\n<div>\n Safety outcomes</div>\n<ol>\n <li>\n Serious adverse events, excluding primary and secondary efficacy outcomes, by 26 weeks from randomization</li>\n <li>\n Serious adverse events within 7 days after the start of each course of PMC, excluding primary and secondary efficacy outcomes.</li>\n <li>\n Adverse events by 26 weeks from randomization</li>\n <li>\n Adverse events within 7 days after start of each course of PMC.</li>\n <li>\n QTc prolongation measured by electro cardio gram (ECG) 4-6 hours after 3rd dose of each course</li>\n</ol>\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_pharmacoecomomic1
      • 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 Th e study will beconducted  in four hospitals in western Kenya chosen from a list of Government or private (e.g. mission) hospitals in the previous Western and Nyanza Provinces, based on patient numbers, available infrastructure and malaria transmission and planned malaria control interventions in the catchment area.</p>\n<p>\n Study staff will include the following:</p>\n<ul>\n <li>\n Coordinating Investigator - Prof Feiko ter Kuile, MD, PhD</li>\n <li>\n PI - Dr Simon Kariuki, PhD</li>\n <li>\n PI - Dr Titus Kwambai, MBChB, MSc</li>\n <li>\n Co-Investigator - Dr Martina Oneko, MD (Paed)</li>\n <li>\n Co-Investigator - Dr Grace Nalwa, MD (Paed)</li>\n <li>\n Co-Investigator - Dr Magdalene Kuria, MD (Paed)</li>\n <li>\n Study Coordinator - Elizabeth Nyothach</li>\n <li>\n Pharmacist - Dr Tony Sang, BPharm</li>\n <li>\n Data manager - Wycliffe Odongo</li>\n <li>\n Clinical officers x 8 persons</li>\n <li>\n Community Interviewers x 9 persons</li>\n</ul>\n
      • other_details_explanation
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI Scientific & Ethics Review Unit approved the trial on 20-Nov-2015</p>\n<p>\n Makerere School of Medicine Research Ethics Commitee approved the trial on 20-Oct-2015</p>\n<p>\n Liverpool School of Tropical Medicine(LSTM) Research Ethics Commitee approved the trial on 14-Dec-2015</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration2.5 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites4
      • multi_country_listKenya\nUganda
      • data_monitoring_committeeYes
      • total_enrolment_per_siteEnrollment expected to be 250 participants for each Kenyan site.\n
      • total_participants_worldwide2212
      • 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_specifyMinor participants i.e. below 18 years of age for whom Informed Consent Form will be signed by their legally acceptable representative. In addition, in accordance with local regulation, minors ≥13 years old with capacity for writing could will sign off on an assent Form.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProf Feiko
      • investigator1_middle_name
      • investigator1_family_nameter Kuile
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressKEMRI/CDC and LSTM, P.O. Box 1578, Kisumu 40100,
      • investigator1_telephone+254 708 739 228
      • investigator1_emailfeiko.terkuile@lstmed.ac.uk
      • organisations_transferred_No
      • number_participants1000
      • notification
      • approval_date24-02-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-01-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p align=\"center\">\n <strong><u>FINAL STUDY SUMMARY/ END OF STUDY REPORT</u></strong></p>\n<p>\n <strong>Title of Proposal:</strong> <em>Malaria Chemoprevention with monthly treatment with dihydroartemisinin-piperaquine for the post-discharge management of severe anaemia in children aged less than 5 years in Uganda and Kenya: A 3-year, multi-centre, parallel-group, two-arm randomized placebo controlled superiority trial</em></p>\n<p>\n <strong>Principal Investigator(s):</strong> <em>Dr Titus Kwambai (co-PI) and Dr Simon Kariuki (co-PI), and </em><em>Prof Feiko ter Kuile (CI)</em></p>\n<p>\n <strong>Centre:</strong> <em>KEMRI, Centre for Global Health Research, Kisumu</em></p>\n<p>\n  </p>\n<p>\n <strong>SERU/NON-SERU/SSC/NON-SSC No.:</strong></p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n <em><strong>SERU:</strong></em><em> KEMRI SERU Protocol No: 2965 </em></li>\n <li>\n <em><strong>NON-SERU:</strong></em>\n <ul>\n <li>\n <em>Liverpool School of Tropical Medicine (LSTM) Research Ethics Committee, UK, Research Protocol No: 14.034 </em></li>\n <li>\n <em>School of Medicine, Research and Ethics Committee (SOMREC), Makerere University College of Health Sciences, Makerere, Uganda.</em></li>\n </ul>\n </li>\n</ol>\n<p style=\"margin-left:54.0pt;\">\n  </p>\n<p>\n <strong>1. Date of scientific and ethics (SERU/SSC/NON-SSC) approval: </strong></p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n <em><strong>SERU:</strong></em>\n <ol>\n <li>\n <em>08 Sep 2015: Protocol (v1.2-25Aug15)</em></li>\n <li>\n <em>20 Nov 2015: Protocol amendment (v2-[amendment]-12Nov15)</em></li>\n <li>\n <em>11 Nov 2016: Protocol amendment (v3-[amendment]-28Oct16)</em></li>\n <li>\n <em>04 Feb 2018: Protocol amendment (v4-[amendment]-06Feb18)</em></li>\n </ol>\n </li>\n <li>\n <em><strong>NON-SERU:</strong></em>\n <ol>\n <li>\n <em>Liverpool School of Tropical Medicine (LSTM) Research and Ethics Committee, Liverpool UK (trial sponsor).</em>\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n <em>14 Dec 2015: Protocol amendment (v2-[amendment]- </em></li>\n <li>\n <em>05 Dec 2016: Protocol amendment (v3-[amendment]-28Oct16)</em></li>\n <li>\n <em>13 Apr 2018: Protocol amendment (v4-[amendment]-06Feb18</em></li>\n </ol>\n </li>\n <li>\n <em>School of Medicine, Research and Ethics Committee (SOMREC), Makerere University College of Health Sciences.</em>\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n <em>05 Feb 2016: Protocol amendment (v2-[amendment]-12Nov15)</em></li>\n <li>\n <em>13 Dec 2016: Protocol amendment (v3-[amendment]-28Oct16)</em></li>\n <li>\n <em>27 Jul 2018: Protocol amendment (v4-[amendment]-06Feb18)</em></li>\n </ol>\n </li>\n </ol>\n </li>\n</ol>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<ol style=\"list-style-type:lower-roman;\">\n <li>\n <strong>Date the study stopped collecting data where applicable:</strong></li>\n</ol>\n<ul>\n <li>\n Date for the last participant was recruited (and enrolment): 24 Apr 2018</li>\n <li>\n Date the last follow up was made. 06 Nov 2018</li>\n</ul>\n<p style=\"margin-left:54.0pt;\">\n  </p>\n<p>\n <strong>2. The copy the last continuing review approval or initial approval if this is the first request for renewal:</strong></p>\n<p>\n <em>See attachments of the last annual approval by SERU dated Sep 05, 2018; this was for protocol v4 (amendment) 06Feb18. Please also find included a copy of the SERU approval (dated 15 Mar 2018) of the currently active protocol (v4-[amendment]-06Feb18).</em></p>\n<p>\n  </p>\n<p>\n <strong>3.Project period covered: </strong><em>This report covers the period between: 20 Sep 2018 to 19 Sep 2019.</em></p>\n<p>\n  </p>\n<p>\n <strong>4. Research objectives: </strong></p>\n<p>\n <em><strong>Objective: </strong></em><em>To determine if 3 months of post-discharge malaria chemoprevention with monthly, 3-day treatment courses of dihydroartemisinin-piperaquine (DP) (PMC-DP) is safe and superior to the standard single 3-day treatment course with artemether-lumefantrine provided as part of standard in-hospital care in reducing all-cause readmissions and deaths by 6 months in the post-discharge management of children less than 5 years of age admitted with severe anaemia.</em></p>\n<p>\n <em><strong>Study Location:</strong></em><em> This is a two-country trial conducted in hospitals in Kenya and Uganda.</em></p>\n<p>\n  </p>\n<p>\n <strong>5. Research progress summary: </strong></p>\n<p style=\"margin-left:18.0pt;\">\n <em>Participant enrolment and follow-up completed</em></p>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:100.0%;\" width=\"100%\">\n <tbody>\n <tr>\n <td colspan=\"4\" style=\"width:77.86%;height:36px;\">\n <ol>\n <li>\n <strong><em>Site Information and Recruitment</em></strong></li>\n </ol>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:30.52%;height:36px;\">\n <p>\n <strong><em>Number of sites</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em>2</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <strong><em>Recruitment status</em></strong></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n <em>Recruiting</em></p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:30.52%;height:36px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <strong><em>Uganda</em></strong></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <strong><em>Kenya</em></strong></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n <strong><em>Total</em></strong></p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:30.52%;height:36px;\">\n <p>\n <strong><em>Target recruitment</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em>Competitive recruitment</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <em>Competitive recruitment</em></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:30.52%;height:36px;\">\n <p>\n <strong><em>Randomized</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em>692</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <em>357</em></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n <em>1049</em></p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:30.52%;height:36px;\">\n <p>\n <strong><em>Follow-up Status</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em> completed</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <em> completed</em></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:3.88%;height:36px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:26.64%;height:36px;\">\n <p>\n <strong><em>Completed 6m</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em>661</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <em>282</em></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n <em>943</em></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:3.88%;height:36px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:26.64%;height:36px;\">\n <p>\n <strong><em>Died</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em>20</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <em>10</em></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n <em>30</em></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:3.88%;height:36px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:26.64%;height:36px;\">\n <p>\n <strong><em>Lost to follow-up (LTFU)</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em>7</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <em>52</em></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n <em>59</em></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:3.88%;height:36px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:26.64%;height:36px;\">\n <p>\n <strong><em>Consent withdrawn</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em>4</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <em>5</em></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n <em>9</em></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:3.88%;height:36px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:26.64%;height:36px;\">\n <p>\n <strong><em>Screening error withdrawal</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em>0</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <em>8</em></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n <em>8</em></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:3.88%;height:36px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:26.64%;height:36px;\">\n <p>\n <strong><em>Total LTFU/withdrawn</em></strong></p>\n </td>\n <td style=\"width:21.36%;height:36px;\">\n <p>\n <em>11</em></p>\n </td>\n <td style=\"width:25.98%;height:36px;\">\n <p>\n <em>65</em></p>\n </td>\n <td style=\"width:22.14%;height:36px;\">\n <p>\n <em>76</em></p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n <strong>6. Amendments: </strong></p>\n<p>\n <em>Three amendments have so far been made and approved by all ethics committees.</em></p>\n<ul>\n <li>\n <em>The first amendment to the protocol (v2-12Nov15) was made before participant recruitment was commenced. The amendment included a change in the brand of dihydroartemisinin-piperaquine from Duo-Cotecxin (Holley Cotec, China) to the GMP formulation Eurartesim® from Sigma Tau, Italy. The dosing schedule for dihydroartemisinin-piperaquine was also updated to follow the revised dose recommendation made by the World Health Organization. </em></li>\n <li>\n <em>The second amended Protocol (v3-[amendment]-28Oct16), was reviewed by SERU on 29 Nov 2016. The amendment included expansion of the number of study sites, clarifications on the participant information sheets, consent forms and minor typological errors in the protocol.</em></li>\n <li>\n <em> The third amended Protocol (v4-[amendment]-06Feb18), was reviewed by SERU on 13 Mar 2018. This included the revision of sample size from 2212 to 1040 overall; 1106 to 520 per arm. This was based on DMEC and TSC recommendation due to a lower than expected rate of loss to follow-up and a higher than expected pooled event rate of the composite primary endpoint across both arms.</em></li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>7. Adverse events reports: (</strong><em>See attached SAE line list)</em></p>\n<p>\n <em>We expected to generate >500 SAEs in this study. This was due to the nature of the study which involved a high-risk study population (children admitted with severe anaemia are at high risk of post-discharge events) and a primary endpoint that itself fulfilled the criteria of an SAE (i.e. death or rebound hospital admission by 6 month). </em></p>\n<p>\n  </p>\n<p>\n <em>By the end of participant follow-up on 6^th Nov, 2018 there was a total of 581 serious adverse events (SAEs) overall from Kenya and Uganda, including 30 deaths. In summary, the SAEs were as following:</em></p>\n<ul>\n <li>\n <em>No fatalities were reported to be related to the study intervention</em></li>\n <li>\n <em>No SUSAR was reported </em></li>\n <li>\n <em>2 events (anaemia) were reported by investigators as possibly related to the study drug dihydroartemisinin-piperaquine (DHA‐PQ).</em></li>\n <li>\n <em>All other SAEs were reported as unrelated to DHA-PQ</em></li>\n</ul>\n<p>\n <em>All events from both countries were reported in an expedited manner to the Data Safety Monitoring Board (DSMB) and the Research and Ethics Committee (REC) of LSTM (the sponsor), and all events in Kenya were also reported to SERU (KEMRI) and all events in Uganda were reported to SOMREC (Makerere). All SAEs were expected given the high-risk study population.  </em></p>\n<p>\n  </p>\n<p>\n <strong>8. Projects outputs: </strong><em>No project outputs yet, the manuscript is nearly completd.</em></p>\n<p>\n  </p>\n<p>\n <strong>9. Constraints: </strong></p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n <em>Our recruitment rate was lower than expected due to </em>\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n <em>acute shortage of blood for transfusion in Western Kenya. This is mainly due to inadequate number of donations especially during the school holiday seasons and occasional shortage of reagents used for screening the blood at the regional blood Banks. Low numbers of potential participants are therefore seen at the study hospitals (referral centres) possibly due to low referral rates from peripheral facilities. Some are referred to private facilities if they have blood for transfusion. We have assisted in blood drives to collect blood for Migori, Homa Bay and Siaya referral hospitals. </em></li>\n <li>\n <em>Following the roll-out of the indoor residual spraying activities in Migori County, we prematurely closed the Migori site because of the drastic reduction in the number of potential participants and event rates. </em></li>\n </ol>\n </li>\n</ol>\n<p>\n  </p>\n<p>\n <strong>10. Any other relevant information: </strong></p>\n<p>\n <em>A continuation approval is not required.</em></p>\n<p>\n  </p>\n<p>\n <strong>11. Plans for the next project year: </strong></p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n <em>Completion of manuscript writing and publication of results</em></li>\n <li>\n <em>Dissemination of study findings to various groups </em>\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n <em>Health management teams of the 4 host counties and study participants</em></li>\n <li>\n <em>Presentation of findings to the division of malaria control at the ministry of health and other partners</em></li>\n <li>\n <em>Presentation of finding at major conferences e.g American Society of Tropical Health and Hygiene (ASTMH 2019).</em></li>\n </ol>\n </li>\n</ol>\n<p>\n  </p>\n
      • implication_results
      • quantity_imported22,242 x DHA-Piperaquine tabs/placebo 20/160mg and 7,980 x DHA-Piperaquine tabs/placebo 40/320mg
      • quantity_dispensed2,951 x DHA-Piperaquine tabs/placebo 20/160mg and 1,563 x DHA-Piperaquine tabs/placebo 40/320mg
      • quantity_destroyedNone
      • quantity_exportedNone
      • balance_site19,291 x DHA-Piperaquine tabs/placebo 20/160mg and 6,417 x DHA-Piperaquine tabs/placebo 40/320mg
      • final_date0000-00-00
      • modified2021-03-01 11:15:20
      • created2015-10-01 13:53:50
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id287
        • application_id424
        • given_nameTitus
        • middle_name
        • family_nameKwambai
        • qualificationMBChB, MSc
        • professional_addressKEMRI Centre for Global Health Research (CGHR), P.O. Box 1578, Kisumu 40100
        • telephone+254 723354238
        • emailtkkwambai@gmail.com
        • created2015-10-01 14:05:13
        • modified2021-01-26 12:14:49
      • 1(array)
        • id290
        • application_id424
        • given_nameSimon
        • middle_name
        • family_nameKariuki
        • qualificationPhD
        • professional_addressKEMRI Centre for Global Health Research (CGHR), P.O. Box 1578, Kisumu 40100
        • telephone+ 254 725 389 246
        • emailskariuki@kemricdc.org
        • created2015-10-21 12:41:46
        • modified2021-01-26 12:14:49
    • SiteDetail(array)
      • 0(array)
        • id341
        • application_id424
        • county_id41
        • site_nameSiaya County Referral Hospital
        • physical_addressSiaya
        • contact_detailsP.O. Box 144-60400
        • contact_personDr Basweti
        • site_capacity(null)
        • misc(null)
        • created2015-10-01 14:05:13
        • modified2021-01-26 12:14:49
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 1(array)
        • id346
        • application_id424
        • county_id43
        • site_nameHoma Bay County Referral Hospital
        • physical_addressHoma Bay
        • contact_detailsP.O. Box 42-40300
        • contact_personDr Francis Ochieng
        • site_capacity(null)
        • misc(null)
        • created2015-10-21 12:56:47
        • modified2021-01-26 12:14:49
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 2(array)
        • id348
        • application_id424
        • county_id44
        • site_nameMigori County Referral Hospital
        • physical_addressSuna
        • contact_detailsP.O. Box 202-40400
        • contact_personDr Wafula Nalwa
        • site_capacity(null)
        • misc(null)
        • created2015-10-21 12:56:47
        • modified2021-01-26 12:14:49
        • County(array)
          • id44
          • county_nameMigori
          • created2012-06-15 10:27:16
          • modified2012-06-15 10:27:16
      • 3(array)
        • id357
        • application_id424
        • county_id40
        • site_nameBusia County Referral Hospital
        • physical_addressBusia
        • contact_detailsP.O. Box 87-50400
        • contact_personDr Barnabas Kigen
        • site_capacity(null)
        • misc(null)
        • created2015-11-05 16:06:02
        • modified2021-01-26 12:14:49
        • County(array)
          • id40
          • county_nameBusia
          • created2012-06-15 10:26:51
          • modified2012-06-15 10:26:51
    • Sponsor(array)
      • 0(array)
        • id224
        • application_id424
        • sponsorLiverpool School of Tropical Medicine (LSTM)
        • sponsor_typeResearch Institution
        • contact_person
        • addressPembroke Place, Liverpool L3 5QA, UK
        • telephone_number+44 0151 7053212
        • fax_number
        • cell_number+44 0151 7053212
        • email_addressS.Roberts@liverpool.ac.uk
        • created2015-10-01 14:05:13
        • modified2021-01-26 12:14:49
  • 2(array)
    • Application(array)
      • id466
      • user_id306
      • trial_status_id7
      • abstract_of_study<p>\n Important life decisions are often taken under stress. More generally, it has been shown that living in the context of poverty may lead to stress (see Haushofer, Johannes and Ernst Fehr, “On the Psychology of Poverty.”  <em>Science </em>344 (2014), 862–867.) Therefore, it is highly important to understand the impact of stress on economic decision-making, because if stress biases decision making (or influences individuals in other negative ways), it may actually worsen poverty, creating a negative feedback loop.</p>\n<p>\n Because the study is motivated by understanding the impact of poverty, we have chosen the context of informal settlement in Nairobi, where research has shown stress levels are high. By allowing us to understand the link between poverty, stress, and economic decision-making, we hope that in the long run this study will inform the design of poverty interventions in Kenya and beyond. For example, if the study finds that stress levels affect social cooperation, this will give us reason to believe that interventions that reduce stress would have an impact on conflict.     </p>\n<p>\n The objective of this study is to explore the effect of hormones on economic behavior. More specifically, it will explore how stress affects in-group/out-group behavior. This study will answer questions on whether stress increases in-group biases and tendency to protect the in-group, or whether stress increases the need for cooperation, increasing positive interaction with the out-group.</p>\n<p>\n         The proposed study will administer hydrocortisone to healthy male participants, and then tests its effects on in-group/out-group behavior. A wide variety of economic games (including dictator, trust, and public goods) will be played. Participants will also play multiple other games requiring social interaction between in-group and out-group participants. The main hypothesis is that higher levels of cortisol will increase prosocial behavior towards the in-group and antisocial behavior towards the out-group.</p>\n
      • study_title<p>\n Hormones and Economic Choice: Evaluating the Effects of Hydrocortisone Administration on Economic Decision Making, Psychology and Social Behavior among Adult Males in Nairobi, Kenya</p>\n
      • laymans_summary(null)
      • short_titleHormones and Economic Choice
      • protocol_noECCT/15/12/04
      • version_no1
      • date_of_protocol20-11-2015
      • study_drugHyrdocortisone
      • disease_conditionNone. This study is on healthy adults
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameHydrocortisone
      • product_type_medical_device_nameCapsule
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresskelvin.kinyua@busaracenter.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)
      • 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_applicantColin West
      • declaration_date120-11-2015
      • declaration_principal_investigatorJohannes Haushofer
      • declaration_date220-11-2015
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p class=\"p1\">\n Healthy adult volunteers between the ages 18-40</p>\n
      • principal_exclusion_criteria<p class=\"p1\">\n Weighs more than 190 lbs (86.2 kg); substantial consumption of alcohol, tobacco, or other drugs; candidate has any of the following infections or medical conditions (liver disease, kidney disease, thyroid disease or hypothyroidism, diabetes, current malaria, TB, osteoporosis, muscle disorder, glaucoma, eye infection, stomach ulcer, ulcerative colitis, diverticulitis, recent abdominal surgery, any heart problem, high or low blood pressure, strongyloides infection, herpes or any genital ulcer disease, immunodeficiency, any other infection or condition); uses or recently used any of the following medications (drugs that induce hepatic enzymes, troleandomycin, chronic high dose aspirin, oral anticoagulants, heart or BP medication, recent vaccination); or has a mental health concern (severe stress, history of depression, anxiety or other psychiatric disorder, is under psychiatric treatment).</p>\n<p class=\"p1\">\n For full details see submitted Checklist for Subject Inclusion</p>\n
      • primary_end_points<p class=\"p1\">\n The primary endpoints of this study  are: salivary cortisol concentration (nanomol/l), a self-report measure of participant's subjective emotional state (PANAS: positive and negative affect schedule), and a series of economic games and behavioral tasks (all of which are standard paradigms in economic and psychological research). </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyExploring the effect of low-doses of hormones on economic and social behaviors
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyBehavioral economics research trial on hormones and economic decision making.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p class=\"p1\">\n The Busara Center for Behavioral Economics lab team has extensive training in conducting scientifically controlled lab experiments, and years of experience in designing, leading, and managing experimental protocols. The lab is under the direction of Busara's senior leadership team: Johannes Haushofer (Prof. at Princeton University), Jeremy Shapiro (PhD in Economics at MIT), Chaning Jang (PhD in Economics, University of Hawaii), and James Vancel (Managing Director of Busara). For more detailed qualifications, see CVs included in this package. </p>\n<p class=\"p1\">\n Study Coordinators: the on-site research staff at Busara will coordinate the study. Busara's staff are managed by Joseph Muiruri (Mr. Mururi is a graduate of the University of Nairobi, and has extensive experience supporting scientific experiments and managing lab project). </p>\n<p class=\"p1\">\n Site facilities: Busara is located in a compound with 24-hr security. The lab facility includes a networked computer cluster (touchscreen computers that can be used by illiterate participants), a waiting room; lab space for saliva sampling, a -20 deg C freezer for specimen storage, continuous and uninterrupted power through a backup system. </p>\n<p class=\"p1\">\n Emergency facilities: Busara has a fully equipped first aid kit, and a licensed nurse will be on-site at all times during this study. </p>\n
      • other_details_explanation<p class=\"p1\">\n The study is designed to understand the impact of poverty. Research has shown that stress levels are high in informal settlements in Nairobi. We hope that our study will inform poverty interventions in Kenya and beyond. </p>\n
      • other_details_regulatory_notapproved<p class=\"p1\">\n None. This study has already been approved by all other applicable regulatory authorities.</p>\n
      • other_details_regulatory_approved<p class=\"p1\">\n 1) Princeton University Institutional Review Board for Human Subjects: approved June 15, 2015 for single site in Kenya;</p>\n<p class=\"p1\">\n 2) Kenya Medical Research Institute (KEMRI): approved October 5, 2015 for single site in Kenya </p>\n
      • other_details_regulatory_rejected<p>\n None. </p>\n
      • other_details_regulatory_halted<p>\n None.</p>\n
      • estimated_duration1 year
      • 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 controlled
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaBusara Center for Behavioral Economics
      • single_site_physical_addressJonathan Court, Ngong Road, Nairobi 0200
      • single_site_contact_personJames Vancel
      • single_site_telephone+(254) 725 066 428
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site11,500 (Single-site in Kenya)
      • total_participants_worldwide11,500
      • 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_nameJohannes
      • investigator1_middle_name
      • investigator1_family_nameHaushofer
      • investigator1_qualificationProfessor, Princeton University
      • investigator1_professional_address427 Peretsman Scully Hall, Princeton, NJ 08540
      • investigator1_telephone001-609-258-7167
      • investigator1_emailhaushofer@princeton.edu
      • organisations_transferred_No
      • number_participants11,500
      • notification<p>\n Note: hard copies of this application were submitted to the PPB offices on November 20, 2015</p>\n
      • approval_date11-03-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-12-2015
      • 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)
      • modified2019-09-30 09:42:57
      • created2015-12-17 16:18:45
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id304
        • application_id466
        • given_nameJohannes
        • middle_name
        • family_nameHaushofer
        • qualificationProfessor, Princeton University
        • professional_address427 Peretsman Scully Hall, Princeton, NJ 08540
        • telephone001-609-258-7167
        • emailhaushofer@princeton.edu
        • created2015-12-17 16:25:59
        • modified2015-12-17 18:11:06
    • SiteDetail(array)
      • 0(array)
        • id363
        • application_id466
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-12-17 16:25:59
        • modified2015-12-17 18:11:06
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id237
        • application_id466
        • sponsorPrinceton University, Department of Psychology
        • sponsor_type(null)
        • contact_person
        • addressPeretsman Scully Hall, Princeton, NJ 08540
        • telephone_number001-609-258-4793
        • fax_number
        • cell_number001-609-258-4793
        • email_addresslscalice@princeton.edu
        • created2015-12-17 16:25:59
        • modified2015-12-17 18:11:06
  • 3(array)
    • Application(array)
      • id441
      • user_id56
      • trial_status_id7
      • abstract_of_study<p>\n  Abstract (300 words):<br />\n Introduction: Hormonal forms of contraception, are used by >150 million women worldwide. Some epidemiologic studies conducted in a variety of contexts have suggested that women using some types of hormonal contraceptives may be at increased risk of HIV acquisition; however, the results across multiple studies have been mixed, with some studies demonstrating increased HIV risk but others not showing increased HIV risk. The best way to address this uncertainty and provide clear policy guidance is with evidence from a large, well designed, randomised clinical trial.<br />\n Objectives: The main objective of this study is to compare the risks of HIV acquisition between women randomised to depot medroxyprogesterone acetate (DMPA), levonorgestrel (LNG) implant, and copper intrauterine device (IUD).<br />\n Methods: We aim to conduct an open-label, 3 armed randomised clinical trial in 12 sites across east and southern Africa comparing DMPA, LNG implant, and copper IUDs. This research design will greatly reduce many of the important limitations to the current body of observational evidence, including selection bias and many confounding factors whether known or unknown. In East Africa, the only site will be the  KEMRI-RCTP study centre at Lumumba health centre in Kisumu County. The Lumumba study site will enrol approximately 1000 sexually active, HIV-negative women, 16-35 years old, seeking effective contraception, willing to be randomised to any of the study arms, and not desiring pregnancy for the duration of study participation. Participants will be randomly allocated to one of three study arms in a 1:1:1 ratio: DMPA, LNG implant, copper IUD. Participants will be followed for upto 18 months per woman or until closure of the study or study site<br />\n Anticipated results: This study has the potential to address the hormonal contraceptive uncertainty among senior policy makers in countries that are highly dependent on injectable progestins and have high HIV prevalence. Results from this study will permit clear guidance for policymakers and programs, clearly formulated counselling messages, and ultimately allow women to make informed choices. Failure to undertake this research will leave a critical public health question unanswered.</p>\n
      • study_title<p>\n <strong>A Multi Centre, Open label, Randomized Clinical Trial, Comparing HIV incidence and Contraceptive Benefits in Women using Depot Medroxyprogesterone Acetate, Levernogestrel (LNG) implant and Copper Intrauterine Devices (IUD).</strong></p>\n<p>\n <strong>Short Title :<em> The Evidence for Contraceptive options and HIV Outcomes (ECHO) Trial</em></strong></p>\n
      • laymans_summary<p>\n N/A</p>\n
      • short_titleThe Evidence for Contraceptive options and HIV Outcomes (ECHO) Trial
      • protocol_noECCT/15/12/02
      • version_no2.0
      • date_of_protocol30-01-2015
      • study_drug Depot Medroxyprogesterone Acetate, Levernogestrel (LNG) implant and Copper Intrauterine Devices (IUD)
      • disease_conditionHIV incidences
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_nameCopper IUD
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaachoka@kemri-ucsf.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_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_applicantImeldah Wakhungu, P.O BOX 614-40100 KISUMU , Mobile No. +254-726605720 email address: iwakhungu@kemri-ucsf.org
      • declaration_date126-10-2015
      • declaration_principal_investigatorProf Elizabeth Anne Bukusi, Principal Investigator P.O BOX 614 -40100, KISUMU
      • declaration_date226-10-2015
      • placebo_presentNo
      • study_objectives<h2>\n Primary Objective</h2>\n<p>\n To compare the risks of HIV acquisition between women randomised to DMPA, LNG implant, and copper IUDs</p>\n<h2>\n Secondary Objectives</h2>\n<ul>\n <li>\n To compare pregnancy rates among women randomised to DMPA, LNG implant, and copper IUDs</li>\n <li>\n To compare rates of serious adverse events among women randomised to DMPA, LNG implant,  and copper IUDs</li>\n <li>\n To compare rates ofadverse events that lead tomethod discontinuation among women randomised to  DMPA, LNG implant,  and copper IUDs</li>\n <li>\n To compare contraceptive method continuation rates among women randomisedto DMPA, LNG implant, and copper IUDs</li>\n</ul>\n<h2>\n Tertiary Objectives</h2>\n<ul>\n <li>\n To evaluate whether age modifies the hormonal contraception and HIV acquisition relationship</li>\n <li>\n To evaluate whether HSV-2 status modifies the hormonal contraception and HIV acquisition relationship</li>\n <li>\n To evaluate early HIV disease progression among seroconvertersrandomisedto DMPA, LNG implant, and copper IUDs</li>\n</ul>\n
      • principal_inclusion_criteria<p>\n <strong> Inclusion Criteria</strong><br />\n To be eligible for the study a woman must meet all of the following criteria:<br />\n • 16-35 years of age<br />\n o Previously pregnant16 and 17 year olds, where permissible by national regulations and local IRB approval<br />\n • HIV-seronegative<br />\n • Wants to use effective contraception<br />\n • Is able and willing to provide written informed consent<br />\n • Agrees to be randomised to either DMPA, LNG implant, or copper IUD<br />\n • Agrees to use assigned method for 18 months<br />\n • Agrees to follow all study requirements<br />\n • Intends to stay in the study area for the next 18 months, and willing and able to provide adequate locator information<br />\n • If has had a recent third trimester birth, is at least 6 weeks postpartum<br />\n • Is sexually active (has had vaginal sex within the last 3 months) or was pregnant within the last 3 months<br />\n • Agrees not to participate in studies of drugs or vaccines or any other clinical research study while participating in this study.<br />\n  </p>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion Criteria</strong><br />\n A woman who reports or is found to have during the screening exam any of the following criteria will be excluded from the study:<br />\n • Reported medical contraindications (WHO MEC Category 3 or 4) to DMPA, LNG implant, or copper IUDs, including:<br />\n o recent septic abortion<br />\n o suspicious unexplained vaginal bleeding<br />\n o breast, cervical, uterine, or ovarian cancer<br />\n o high BP or heart disease, venous thromboembolism, stroke, or diabetes<br />\n o liver disease or liver tumours<br />\n o use of liver enzyme inducing medications (see Appendix 9)<br />\n • Is found to have pelvic tuberculosis or uterine fibroids with distortion of the uterine cavity on pelvic exam<br />\n • Has untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhea or chlamydia<br />\n • Has  received a DMPA or NET-En injection in the last 6 months<br />\n • Has used an implant or an IUD in the last 6 months<br />\n • Is pregnant or intending to become pregnant in the next 18 months<br />\n • Has had a hysterectomy or sterilization<br />\n • Has previously participated in the study<br />\n • Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation.</p>\n
      • primary_end_points<p>\n <strong> Primary Endpoint</strong></p>\n<p>\n <br />\n • HIV infection as measured by documented HIV seroconversion occurring post-enrolment.</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_specifyComparing HIV Incidence and Contraceptive Benefits in Women using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)
      • 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 Number of staff: </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Not Applicable</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n <strong>FHI 360</strong>: Approved February 25th 2015</p>\n<p>\n <strong>WHO : </strong>Approved January 7th 2015</p>\n<p>\n <strong>KEMRI ERC: </strong>Approved 15th Sept 2015</p>\n<p>\n <strong>A total of 12 sites </strong></p>\n<p>\n <strong>Number of sites per country:</strong></p>\n<p>\n <strong>Kenya :- 1 site</strong></p>\n<p>\n <strong>Zambia : -1 site</strong></p>\n<p>\n <strong>Swaziland :- 1 site</strong></p>\n<p>\n <strong>South Africa :- 9 sites</strong></p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration3 years in total, 18months follow up per participant
      • 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_comparatorCompare the risks of HIV
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-RCTP Study center , Lumumba
      • single_site_physical_addressLUMUMBA HEALTH CENTRE , AGOI STREET, KISUMU
      • single_site_contact_personProf. Bukusi
      • single_site_telephone+254-726605720
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4 states
      • number_of_sites
      • multi_country_listSouth Africa, Swaziland, Zambia, Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site1,000
      • total_participants_worldwide7,800
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • 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_nameNot Applicable. KEMRI RCTP-Lumumba Study Center is the only Kenyan site.
      • investigator1_middle_nameNot Applicable
      • investigator1_family_nameNot Applicable
      • investigator1_qualificationNot Applicable
      • investigator1_professional_addressNot Applicable
      • investigator1_telephoneNot Applicable
      • investigator1_emailiwakhungu@kemri-ucsf.org
      • organisations_transferred_Yes
      • number_participants1,000
      • notification<p>\n NONE</p>\n
      • approval_date11-04-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonYour study is now approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-05-28 11:08:15
      • created2015-10-24 11:00:26
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id294
        • application_id441
        • given_nameProf Elizabeth
        • middle_nameAnne
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics)
        • professional_addressP.O BOX 614 -40100 KISUMU
        • telephoneLand line 254 20 6751748(Nairobi) 254 57 2021036
        • emailebukusi@kemri.org
        • created2015-10-24 11:10:53
        • modified2020-05-28 11:08:15
    • SiteDetail(array)
      • 0(array)
        • id351
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        • misc(null)
        • created2015-10-24 11:10:53
        • modified2020-05-28 11:08:15
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        • id229
        • application_id441
        • sponsorFHI 360
        • sponsor_typeResearch Institution
        • contact_personNikki Messenger
        • address359 Blackwell St. Durham, NC, 27707 USA
        • telephone_number1.919.544.7040 Ext. 11723
        • fax_numberNot applicable
        • cell_numberNot applicable
        • email_addressnmessenger@fhi360.org
        • created2015-10-24 11:10:53
        • modified2020-05-28 11:08:15
  • 4(array)
    • Application(array)
      • id437
      • user_id301
      • trial_status_id5
      • abstract_of_study<p>\n  </p>\n<p align=\"center\">\n <strong>Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN): </strong><strong>A</strong> <strong>Prospective randomized, placebo-controlled, double-blinded clinical trial in western Kenya.</strong></p>\n<p align=\"center\">\n  </p>\n<p>\n <strong><u>Background:</u></strong>Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world.  Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) holds promise to reduce the rate of PTB substantially.</p>\n<p>\n <strong><u>Hypothesis:</u></strong>First trimester administration of aspirin will reduce the risk of preterm birth.</p>\n<p>\n <strong><u>Study Design Type:</u></strong>Prospective randomized, placebo-controlled, double-blinded multicenter clinical trial. Trial will be individually randomized with one-to-one ratio (intervention/control)</p>\n<p>\n <strong><u>Population:</u></strong>Nulliparous women between the ages of 18and 40,with a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin. Minors who are ≥ 14 years of age may be enrolled if permitted by the country’s ethical guidelines. </p>\n<p>\n <strong><u>Intervention:</u></strong>Daily administration of low dose (81 mg) aspirin[also known as acetylsalicylic acid (ASA], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo.Compliance and outcomes will be assessed biweekly.</p>\n<p>\n <strong><u>Outcomes:</u></strong></p>\n<p>\n <strong><em>Primary outcome</em>:</strong> To determine whether daily LDA initiated between 6 0/7 -13 6/7 weeksGA and continued to 36 0/7 weeks GA reduces the risk of PTB (birth prior to 37 0/7 weeksGA).</p>\n<p>\n  </p>\n<p>\n <strong><em>Secondary outcomes</em></strong> of interest are the rate of preeclampsia/eclampsia, small for gestational age (SGA), and perinatal mortality.</p>\n<p>\n  </p>\n
      • study_title<p>\n  </p>\n<p align=\"center\">\n <strong>Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN): </strong><strong>A</strong> <strong>Prospective randomized, placebo-controlled, double-blinded clinical trial in western Kenya.</strong></p>\n
      • laymans_summary(null)
      • short_title A Randomized Controlled Trial of ASPIRIN in Nulliparous Pregnant Women(ASPIRIN STUDY)
      • protocol_noECCT/15/12/01
      • version_noAspirin Protocol V1.0
      • date_of_protocol10-03-2015
      • study_drugLow Dose (81mg) Aspirin(Acetylsalicylic acid)(ASA)
      • disease_conditionPreterm Births
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameAcetylsalicylic Acid (ASA)
      • product_type_medical_device_nameAcetylsalicylic Acid (ASA)
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdrpaulnyongesa@yahoo.com
      • applicant_covering_letter1
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      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
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      • applicant_addendum1
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      • applicant_gcp_training(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Paul Nyongesa
      • declaration_date123-10-2015
      • declaration_principal_investigatorProf Fabian Esamai
      • declaration_date223-10-2015
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<h3>\n 1.1.1          Inclusion Criteria</h3>\n<p style=\"margin-left:.25in;\">\n §  Nulliparous women between 18 – 40 years of age. Minors who are ≥ 14 years of age may be enrolled if permitted by the country’s ethical guidelines. </p>\n<p style=\"margin-left:.25in;\">\n §  No more than two previous first trimester pregnancy losses</p>\n<p style=\"margin-left:.25in;\">\n §  No medical contraindications to aspirin;</p>\n<p style=\"margin-left:.25in;\">\n §  Single live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an earlydating ultrasound and with heart rate greater than >110 bpm.</p>\n
      • principal_exclusion_criteria<h3>\n 1.1.1          Exclusion Criteria</h3>\n<p style=\"margin-left:.25in;\">\n §  Women prescribed dailyaspirin for more than 7 days;</p>\n<p style=\"margin-left:.25in;\">\n §  Multiple gestations;</p>\n<p style=\"margin-left:.25in;\">\n §  Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation. Subsequent discovery of a fetal anomaly is not viewed as an exclusion.);</p>\n<p style=\"margin-left:.25in;\">\n §  Hemoglobin  <7.0 gm/dl at screening;</p>\n<p style=\"margin-left:.25in;\">\n §  Any other medical conditions that may be considered a contraindication per the judgment of the site investigator (e.g., Lupus, Type 1 Diabetes, hypertension, or any other known significant disease)</p>\n
      • primary_end_points<p>\n <strong><em>Primary end point: </em></strong>Delivery at < 37 0/7 weeks gestation</p>\n<p>\n Secondary endpoints:  Preeclampsia and eclampsia,,</p>\n<p>\n                                  Small for gestational age(less than 10th percentile) and</p>\n<p>\n                                  Perinatal mortality(stillbirths and first week neonatal deaths)</p>\n
      • scope_diagnosis1
      • 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_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Capacity of The Global Network Kenya Site 12:</p>\n<p>\n TheGlobal Network  Kenya site12 is a research unit of the Global Network for Women's and Children's Health Research and part of the Academic Model Providing Access to Health Care(AMPATH) program in Western Kenya. AMPATH supports the Ministry of Health in 8 counties of Western Kenya Region with a catchment population of 21 million people .</p>\n<p>\n Kenya site 12 has 12 clusters for the Aspirin study located at: Amukura/421,Lukolis/411,Nasewa/425,Matayos/415,Madende/Khayo/414,Khunyangu/422,Bumala B/418, Bokoli/413,Chwele /417,Sirisia/426,Makunga/419,Mumias/423</p>\n<p>\n Number of Study Staff: 60-100 including Investigators, sonograghers,study,clinical and field coordinators, registry and data personnel, community health workers and support stall.</p>\n<p>\n Investigators and study coordinators: Principal Investigator: Prof Fabian Esamai, Consultant Paediatrician  and Professor of Child Health, Moi University, Senior Foreign Investigator with The Global Network for Women's and Children's Health with many years research experience (see CV). Dr. Paul Nyongesa, Consultant Obstetrician/Gynaecologist, Senior Lecturer, Moi University (see CV) and M/s Emma Achieng, Senior Tutor in Midewifery and Study Coordinator with Global Network for 5years.</p>\n<p>\n Site Facilities:</p>\n<p>\n Moi University, College of Health Sciences, Medical School, Moi Teaching and Referral Hospital and Western Kenya Region of Community Health Units,Dispensaries,Health Centres, sub-County and County Referral Hospitals. </p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n   1. Christiana Care Institutional Review Board, New Jersey, USA  approved on 27th April 2015</p>\n<p>\n   2. JNMC Insttutional Ethics Committee on Human Subjects, Belgaum, India.approved 28th March 2015 for one site  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration18months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_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_countriesYes
      • multiple_member_states6
      • number_of_sites12
      • multi_country_listDemocratic Republic of Congo, Zambia, Kenya,Nagpur India,Belgaum India, Pakistan and Guatemala
      • data_monitoring_committeeYes
      • total_enrolment_per_site150
      • total_participants_worldwide 11,920
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyParticipants incapable of giving consent personally,such as pregnant adolescent minors will assent and have informed consent given by husbands, if married, or guardians.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Paul Nyongesa
      • investigator1_middle_nameJohn
      • investigator1_family_nameObanda
      • investigator1_qualificationMbChB(U.O.N.), MMed(OB Gyn)(U.O.N.)
      • investigator1_professional_addressCollege of Health Sciences,Moi University,Dept of Reproductive Health Box 4606 30100 Eldoret ,Kenya
      • investigator1_telephone0733 788 063
      • investigator1_emaildrpaulnyongesa@yahoo.com
      • organisations_transferred_No
      • number_participants 1800
      • notification<p>\n Not applicable</p>\n
      • approval_date16-02-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-12-2015
      • 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)
      • modified2025-07-15 15:52:54
      • created2015-10-22 12:04:18
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
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        • id293
        • application_id437
        • given_nameProf Fabian Esamai
        • middle_nameOmoding
        • family_nameEsamai
        • qualificationMbChB, MMed(Paed),MPH,PhD
        • professional_addressCollege of Health Sciences,Moi University,Dept of Child Health and Paediatrics Box 4606 30100 Eldoret ,Kenya
        • telephone0733 836 410
        • emailfesamai2007@gmail.com
        • created2015-10-22 12:23:49
        • modified2015-12-07 13:28:38
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        • application_id437
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        • site_nameAmukura, Lukolis,Nasewa,Matayos,Khunyangu, Bumala B
        • physical_addressWestern Kenya
        • contact_details Box 4606 30100 Eldoret, Kenya.0733 788 063 and 0733 836 410
        • contact_personDr. Paul Nyongesa and Prof Fabian Esamai
        • site_capacity(null)
        • misc(null)
        • created2015-10-22 12:23:49
        • modified2015-12-07 13:28:38
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          • county_nameBusia
          • created2012-06-15 10:26:51
          • modified2012-06-15 10:26:51
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        • application_id437
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        • site_nameSirisia, Chwele, Bokoli
        • physical_addressWestern Kenya
        • contact_details Box 4606 30100 Eldoret, Kenya.0733 788 063 and 0733 836 410
        • contact_personDr. Paul Nyongesa and Prof Fabian Esamai
        • site_capacity(null)
        • misc(null)
        • created2015-10-29 10:38:39
        • modified2015-12-07 13:28:38
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          • id39
          • county_nameBung\'oma
          • created2012-06-15 10:26:45
          • modified2012-06-15 10:26:45
      • 2(array)
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        • application_id437
        • county_id37
        • site_nameMakunga, Mumias
        • physical_addressWestern Kenya
        • contact_details Box 4606 30100 Eldoret, Kenya.0733 788 063 and 0733 836 410
        • contact_personDr. Paul Nyongesa and Prof Fabian Esamai
        • site_capacity(null)
        • misc(null)
        • created2015-10-29 10:38:39
        • modified2015-12-07 13:28:38
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
    • Sponsor(array)
      • 0(array)
        • id228
        • application_id437
        • sponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
        • sponsor_type(null)
        • contact_personMenachem Miodovnik, MD
        • addressNational Institutes of Health 6100 Executive Blvd, Rm 4B03A Bethesda, MD 20892-7510
        • telephone_number): 301-451-5031
        • fax_number: 301-496-3790
        • cell_number): 301-451-5031
        • email_addressMenachem.Miodovnik@nih.gov
        • created2015-10-22 12:23:49
        • modified2015-12-07 13:28:38
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