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      • id1073
      • user_id336
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      • abstract_of_study<p>\n <strong>Introduction</strong>: The primary objective is to evaluate the non-inferiority of a simplified magnesium sulfate regimen [10 g intramuscular (IM) 12 hourly x 2 doses] compared with a standard magnesium sulfate regimen [either 4g intravenous (IV) loading dose, followed by a maintenance dose of 1g/hour until 24 hours (“Zuspan regimen”) or 4g IV plus 10 g IM loading dose, followed by 5 g IM 4 hourly until 24 hours (“Pritchard regimen”)] for the prevention of maternal eclamptic seizure.</p>\n<p>\n  </p>\n<p>\n <strong>Methods  and materials</strong></p>\n<p>\n This will be a phase III, multicountry, multicentre, two-arm, parallel, open-label, active-controlled, randomized, non-inferiority trial.  The study population will be women diagnosed with pre-eclampsia and with a clinical or laboratory indication for magnesium sulfate treatment before giving birth or within 24 hours of giving birth. Eligible, consenting women will be randomized to receive either 10 g of magnesium sulfate IM 12 hourly x 2 doses or a standard IV (Zuspan) or standard IM (Pritchard) magnesium sulfate regimen depending on the standard treatment protocol in the participating hospitals.  Standard IV regimen will be 4g IV as loading dose, followed by IV infusion of 1g per hour for 24 hours whereas standard IM regimen will be administered as 4g IV plus 10 g IM loading dose, followed by 5 g IM every 4 hours for 24 hours. Outcome measurements will be conducted in women and their babies until the time of hospital discharge or transfer to a higher care unit or death. The primary outcome will be the occurrence of maternal eclamptic seizure. <strong>Statistical methods:</strong> In order to demonstrate non-inferiority within a margin of 0.51%, with a power of 80% and with a significance level of 2.5%, a total of 11,596 women (5,798 per group) are needed assuming equal eclampsia prevalence of 0.97% in the standard treatment group and the simplified treatment group. Assuming 3% drop-outs due to exclusion of women after randomization and those who are not protocol-compliant, the estimated sample size will be 11,959 women. The first interim analysis will be conducted for the Data Safety Monitoring Committee (DSMC) to assess safety and futility when 2400 women (1200 per arm) have been recruited. Second interim analysis will be conducted when 6000 women (3000 per arm) have been recruited to assess safety, efficacy, and futility. Final noninferiority analysis will be performed when total sample size of 12000 women is achieved.</p>\n<p>\n  </p>\n<p>\n <strong>Utility </strong></p>\n<p>\n Lack of resources to administer IV medication and provide supportive care and/or repeated IM administration of magnesium sulfate may be associated with pain due to the large volume for injection and risk of infection at the injection site. These challenges have turned the attention of health care workers towards seeking and testing alternative dosage regimens for magnesium sulfate. This approach has largely been driven by the intention to improve coverage of a life-saving treatment for women with pre-eclampsia, minimize potential adverse effects, reduce resources that are required for administering the complex standard regimens, and to encourage task sharing among health care providers where necessary</p>\n
      • study_title<p>\n Simplified Treatment for Eclampsia Prevention using Magnesium sulfate:  A phase III, randomized, open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial)</p>\n
      • laymans_summary<p>\n <strong>S</strong>implified <strong>T</strong>reatment for <strong>E</strong>clampsia <strong>P</strong>revention using <strong>Mag</strong>nesium sulfate</p>\n
      • short_titleSTEP-Mag Trial
      • protocol_noECCT/22/01/05
      • version_no2.2
      • date_of_protocol23-04-2021
      • study_drugMagnesium Sulphate
      • disease_conditionPreeclampsia
      • 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_nameMagesium Sulphate
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresszahida@qureshi.co.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
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      • declaration_applicantUniversity of Nairobi, Faculty of Health Services, Department of Obstetrics and Gynaecology
      • declaration_date125-01-2022
      • declaration_principal_investigatorProf. Zahida Qureshi, Principal Investigator
      • declaration_date225-01-2022
      • placebo_presentNo
      • study_objectives<h3>\n 1.1.1.Primary objective </h3>\n<p>\n The primary objective of this trial is to evaluate non-inferiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen in the prevention of maternal eclamptic seizure.</p>\n<p>\n <strong>Secondary objective</strong></p>\n<p>\n The secondary objective of this trial is to evaluate superiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen in the proportion of women experiencing adverse events indicative of magnesium toxicity.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n To be eligible for inclusion into this trial, the women must fulfill <strong><u>all</u></strong> of the following criteria:</p>\n<p>\n  </p>\n<ol>\n <li style=\"text-align: justify;\">\n Be admitted with a diagnosis of pre-eclampsia and with clinical or laboratory indication(s) for magnesium sulfate treatment, as defined by any of the following: two readings of systolic blood pressure ≥160 mm Hg, or diastolic blood pressure ≥110 mm Hg along with ≥2+ proteinuria on urine dipstick; or the presence of symptoms, signs or laboratory findings suggestive of severe disease such as headache, visual disturbances, upper abdominal pain, pulmonary oedema, nausea and vomiting, hyperreflexia or clonus, elevated liver enzymes, raised serum creatinine, or thrombocytopenia. Women with HELLP syndrome, a severe form of pre-eclampsia characterized by <strong>H</strong>aemolysis, <strong>E</strong>levated <strong>L</strong>iver enzymes, and <strong>L</strong>ow <strong>P</strong>latelets (<100 cells/mcl) will be included if there is no clinical contraindication to IM injection.</li>\n <li style=\"text-align: justify;\">\n Have not yet given birth but birth is planned or expected within the next 24 hours, or have given birth within the last 24 hours.</li>\n <li style=\"text-align: justify;\">\n Provide written informed consent before any trial-related procedures are carried out.</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Women are not eligible if they fulfill <strong><u>any</u></strong> of the following exclusion criteria:</p>\n<p>\n  </p>\n<ol>\n <li style=\"text-align: justify;\">\n Unable or unwilling to give informed consent (because the woman is too distressed or not capable to understand, confirm and give informed consent due to emergency or health condition, or does not wish to be randomized for whatever reason). </li>\n <li style=\"text-align: justify;\">\n Are non-emancipated minors (as per local regulations) without a guardian.</li>\n <li style=\"text-align: justify;\">\n History of hypersensitivity to magnesium sulfate.</li>\n <li style=\"text-align: justify;\">\n Serious cardiovascular disorders (WHO classification III or IV or acute heart failure).</li>\n <li style=\"text-align: justify;\">\n Serious hepatic (encephalopathy or coma) or renal disease.</li>\n <li style=\"text-align: justify;\">\n History of epilepsy.</li>\n <li style=\"text-align: justify;\">\n Myasthenia gravis or any muscular dystrophies.</li>\n <li style=\"text-align: justify;\">\n Coagulopathy.</li>\n <li style=\"text-align: justify;\">\n Have previously received magnesium sulfate for eclampsia prevention in the current pregnancy.</li>\n <li style=\"text-align: justify;\">\n Planned to receive magnesium sulfate regimen other than the regimens specified for the trial on account of other medical indication(s) (e.g. fetal neuroprotection).</li>\n <li style=\"text-align: justify;\">\n Known oliguria (<400mL urine in 24 hours) at the time of admission.</li>\n</ol>\n
      • primary_end_points<p style=\"margin-left:27.0pt;\">\n Maternal eclamptic seizure</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
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      • scope_pharmacodynamic0
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      • scope_dose_response0
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      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
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      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Mama Lucy Hospital</strong> is a level 4 hospital located in the city of Nairobi. It handles over 1000 deliveries per month.</p>\n<p>\n It has a 66 bed maternity ward with 41 nurses, 6 consultant obstetricians/gynaecologists, and 2 Clinical Officers</p>\n<p>\n <strong>Nakuru Level 5 Hospital</strong> is a public level 5 urban hospital in Nakuru, Kenya. It handles over 1000 deliveries per month.</p>\n<p>\n It has an 18 bed maternity ward with 30 midwives, 4 house officers and 2 consultant obstetricians/gynaecologists.</p>\n<p>\n <strong>Naivasha County Referral Hospital Level 5</strong> is a public level 5 urban hospital in Thika, Kenya. It handles approximately 1000 deliveries per month.</p>\n<p>\n It has a 89 bed maternity ward with 17 midwives, 2 house officers and 1 full time consultant obstetricians/gynaecologists. </p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">This is a multi-country trial conducted in five countries, where WHO is the trial sponsor</span></p>\n
      • other_details_regulatory_notapproved<p>\n <em>Other countries are in preparation as well (India, Malawi, Nigeria, South Africa, Uganda)</em></p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStandard intervention
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites3
      • multi_country_listIndia\nKenya\nNigeria \nMalawi \nUganda
      • data_monitoring_committeeYes
      • total_enrolment_per_siteMama Lucy Hospital-341\nNakuru Level 5- 392\nNaivasha Sub-county hospital-331
      • total_participants_worldwide12000
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameZahida
      • investigator1_middle_name
      • investigator1_family_nameQureshi
      • investigator1_qualificationAssociate Professor
      • investigator1_professional_addressP.O.BOX 19676-00202, Department of Obstetrics and Gynaecology, University of Nairobi, Kenyatta National Hospital campus, Nairobi, Kenya
      • investigator1_telephone+254733605140
      • investigator1_emailzahida@qureshi.co.ke
      • organisations_transferred_No
      • number_participants1064
      • notification
      • approval_date15-05-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-02-2022
      • is_child0
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      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer queries have been addressed
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      • final_date(null)
      • modified2023-06-07 16:43:29
      • created2021-10-12 06:47:01
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      • ecitizen_invoice(null)
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        • id737
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        • given_nameZahida
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        • family_nameQureshi
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        • professional_addressP.O.BOX 19676-00202, Department of Obstetrics and Gynaecology, University of Nairobi, Kenyatta National Hospital campus, Nairobi, Kenya
        • telephone+254733605140
        • emailzahida@qureshi.co.ke
        • created2021-10-12 06:57:00
        • modified2022-02-22 07:47:28
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        • id1137
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        • site_nameNakuru Level V Hospital
        • physical_addressshow ground road
        • contact_detailsP.O. Box 71-20100
        • contact_personDr. Barassa
        • site_capacity(null)
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        • created2021-10-12 06:57:00
        • modified2022-02-22 07:47:28
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          • id32
          • county_nameNakuru
          • created2012-06-15 10:25:52
          • modified2012-06-15 10:25:52
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        • id1138
        • application_id1073
        • county_id47
        • site_nameMama Lucy Kibaki Hospital
        • physical_addressKangundo road
        • contact_detailsP.O. Box 34349-00100
        • contact_personDr. Mutua
        • site_capacity(null)
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        • created2021-10-12 07:10:44
        • modified2022-02-22 07:47:28
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          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
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        • site_nameNaivasha Level IV Hospital
        • physical_addressNaivasha
        • contact_detailsP.O.B ox 141 Naivasha
        • contact_personDr. Chege
        • site_capacity(null)
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        • created2021-10-12 07:10:44
        • modified2022-02-22 07:47:28
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          • created2012-06-15 10:25:52
          • modified2012-06-15 10:25:52
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        • id544
        • application_id1073
        • sponsorWHO
        • sponsor_typeResearch Institution
        • contact_person
        • addressGeneva
        • telephone_number+41227912111
        • fax_number
        • cell_number+41227912111
        • email_addresschoud@who.int
        • created2021-10-12 06:57:00
        • modified2022-02-22 07:47:28
  • 1(array)
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      • user_id71
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      • abstract_of_study<p>\n Background: This large, international, randomized controlled clinical trial is designed to enable an expeditious, agile and concurrent evaluation of the benefits and risks of multiple candidate preventive vaccines against COVID-19 at international sites with sufficient COVID-19 attack rates. The trial is designed to provide sufficient evidence of safety and vaccine efficacy against COVID-19 to support decision-making about global vaccine deployment, which may include licensure and/or WHO pre-qualification. Final decisions about COVID-19 deployment will be made in each jurisdiction. Simplicity of procedures: Within each country, the investigator invites selected sites and helps them get ethical and regulatory approval and study vaccines, then volunteers’ recruitment can begin. To facilitate collaboration volunteer’s enrolment and randomisation (via a cloud-based GCP-compliant platform) and all other trial procedures are greatly simplified, and no paperwork is required. Once consent has been obtained, electronic entry of anonymised details of a few key characteristics of each volunteer takes only a few minutes. At the end of patient entry, a random vaccine allocation is generated. Eligibility: Adults (age ≥ 16 years), capable of giving personal signed informed consent, healthy participants who are determined by clinical judgment of the investigator to be eligible for inclusion in the study. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests (if randomised and consent given, lifestyle considerations, and other study procedures. Consent: The study website https://data.castoredc.com/studies has printable volunteer information in some UN official languages. Once the information has been explained to volunteers, obtaining consent takes only a few minutes. An electronic image of the signature page is kept (or, if national regulations forbid this, a note to file), and the printed information and original consent stays with the volunteer or legal representative. Trial entry; randomization: Once electronic data collection has been completed the volunteer automatically enters the trial and a random allocation of their trial vaccine is generated (by an algorithm that ensures eventual balance in the characteristics just recorded between each study vaccines and its placebos) and displayed. The volunteers will be randomly allocated either to placebo or to one of the study vaccines. Safety: Evaluation of COVID-19 vaccine safety is one of the primary objectives of this trial. All sites will monitor and report serious adverse events (SAEs) at any time after vaccination, by baseline SARS-CoV-2 serostatus where available. Follow-up: Each participant will be contacted weekly for 52 weeks for information as to whether any potentially relevant symptoms have arisen, with laboratory testing triggered if the report suggests COVID-19. Primary objective: The primary objective is to evaluate the effect of each vaccine on the rate of virologically confirmed COVID-19 disease, regardless of severity. Secondary and exploratory objectives. Although the study may lack power for formal statistical inference about vaccine efficacy against severe disease and death due to COVID-19, this secondary endpoint will be calculated and reported for each vaccine. For vaccines that are shown to be effective, their duration of efficacy also will be formally evaluated as a pre-specified secondary endpoint. Additional exploratory endpoints will include VE between the first and second dose, for two-dose vaccine. In addition, VE against specific SARS-CoV-2 variants of concern (as defined by WHO)will be evaluated as a high priority supportive end-point. This will also include a VE analysis in terms of variant-specific mutations and/or dele-tions. Every effort will be made to collect samples for sequencing from cases that occur in the trial. These will be used for various purposes, including assessment of the effects of vaccination on the immune response and on the secondary endpoint of rate of infection with SARS-CoV-2. For candidate vaccines for which both the independent Working Group on Vaccine Prioritization and Trial Steering Committee makes the recommendation on the need for additional safety information before a large number of volunteers is recruited, the following procedures apply. Before proceeding to the recruitment of a larger number of volunteers, the DSMC will review the safety data seven days and thirty days post administration of the last dose. Numbers entered: The trial will rapidly enrol and individually randomize large numbers of adult participants. The trial is endpoint driven, as the main analysis for each vaccine arm versus the concurrent shared placebo/control arm is triggered by occurrence of a total of 150 cases of COVID-19 across these two arms, at which point the results will be reported but blinded follow-up will continue. This fixed number of 150 endpoints is set to provide sufficient power to detect a predefined target level of VE, rejecting the initially specified null hypothesis that VE is < 30%. Adaptive design: A global Data Monitoring Committee will keep the accumulating safety results and major outcome results under regular review. Different candidate vaccines may be available or suitable to enter the trial at different times; for each candidate vaccine, the primary efficacy results are expected within 3-6 months of the vaccine entering the trial. By using a shared placebo/control group and a common Core protocol to evaluate multiple candidate vaccines in the trial, resources allocated to the evaluation of each candidate vaccine are judiciously saved while a high standard of scientific rigor and efficiency is ensured. Add-on studies: Particular countries, or particular groups of sites, may want to collaborate in making further measurements or observations. These could be thought of as Phase 2b trials that are being conducted concurrently with the Phase 3 trial. However, while well-organised additional research studies of additional secondary and supportive endpoints, for which monitoring is valuable but optional at each study site include infection with SARS-CoV-2, trans-mission of SARS-CoV-2, and possible immunological markers as correlates of risk could well be valuable, they are not core requirements in every site. Data security: Patient information will be encrypted and held securely by the WHO. Those analysing it will use only anonymised data, and no identifiable patient details will appear in publications. Publication: This international collaboration is co-ordinated through the World Health Organisation. Major findings will be disseminated by the WHO and published in the names of the collaborators</p>\n
      • study_title<p>\n Solidarity Trial Vaccines: An international randomised trial of candidate vaccines against COVID-19</p>\n
      • laymans_summary<p>\n The disease is called COVID-19 because it was first discovered in 2019, but I’ll just call it COVID. It’s caused by a new virus that can be passed between people touching or passed through the air when an infected person coughs or sneezes, so the hospital staff wear protective clothing. Most people with COVID get better without coming to the hospital, and most who come to the hospital also get better, although they may get worse before they get better. But, a few of those in the hospital die from the illness. The World Health Organisation is organising a trial in many countries in which various potential vaccines are studied, to see whether they are of any use to prevent COVID</p>\n
      • short_titleSolidarity Trial Vaccines
      • protocol_noECCT/22/03/10
      • version_no4.0
      • date_of_protocol08-03-2022
      • study_drugCOVI-VAC,INO-4800,MVC-COV1901and PTX-COVID19-B Vaccine
      • disease_conditionCovid-19
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjnyange@kaviuon.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
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      • declaration_applicantProf Omu Anzala
      • declaration_date130-03-2022
      • declaration_principal_investigatorProf Omu Anzala
      • declaration_date230-03-2022
      • placebo_presentYes
      • study_objectives<p>\n Primary objective: The primary objective is to evaluate the effect of each vaccine on the rate of virologically confirmed COVID-19 disease, regardless of severity.</p>\n<p>\n Secondary and exploratory objectives. Although the study may lack power for formal sta-tistical inference about vaccine efficacy against severe disease and death due to COVID-19, this secondary endpoint will be calculated and reported for each vaccine. For vaccines that are shown to be effective, their duration of efficacy also will be formally evaluated as a pre-specified secondary endpoint. Additional exploratory endpoints will include VE between the first and second dose, for two-dose vaccine. In addition, VE against specific SARS-CoV-2 variants of concern (as defined by WHO) will be evaluated as a high priority supportive end-point. This will also include a VE analysis in terms of variant-specific mutations and/or dele-tions. Every effort will be made to collect samples for sequencing from cases that occur in the trial. These will be used for various purposes, including assessment of the effects of vac-cination on the immune response and on the secondary endpoint of rate of infection with SARS-CoV-2. For candidate vaccines for which both the independent Working Group on Vaccine Prioritiza-tion and Trial Steering Committee makes the recommendation on the need for additional safety information before a large number of volunteers is recruited, the following procedures apply. Before proceeding to the recruitment of a larger number of volunteers, the DSMC will review the safety data seven days and thirty days post administration of the last dose.</p>\n
      • principal_inclusion_criteria<p>\n Inclusion criteria o Male or female participants between the ages of 16 and above at randomization o Living in the area and planning to reside in the area for at least 6 months. o Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent as described in SOP-03 o Healthy participants who are determined by clinical judgment of the investigator to be eligible for inclusion in the study. o Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests (if randomised and consent given, lifestyle considerations, and other study procedures.</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria o Previous laboratory confirmed diagnosis of COVID 19. o Previous vaccination with any COVID-19 vaccine. o Receipt of medications intended to prevent COVID 19. o Participation in other studies involving a study intervention within 28 days prior to study entry and/or during study participation. o History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s). o Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. o Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. o Women who are pregnant or breastfeeding will be informed that there is no data on the safety of these vaccines among these groups and will be given the opportunity to decide if they are willing to participate in the trial.</p>\n
      • primary_end_points<p>\n The primary objective is to evaluate the effect of each vaccine on the rate of virologically confirmed COVID-19 disease, regardless of severity. The primary endpoint is selected for its clinical relevance and because it makes feasible the accrual of sufficient numbers of primary endpoint events to provide adequate power for the trial. Laboratory confirmed COVID-19 disease rates for each vaccine will be compared with COVID-19 rates for the shared concurrently randomized placebo/control group</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • 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_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Sites Study staff ,Pharmacy, Lab ,Data, Community, Clinic space</p>\n<p>\n KAVI-ICR KNH site Number of Staff: 1 physician, I pharmacist, 5 pharmacy staff, 4 trial clinicians, 6 nurse counselors, 2 community staff, 1 data IT/Data manager, 1 Data staff and 8 lab staff, I labaratory Manager Site Facilities: Clinic, Labaratory, data and Pharmacy space available on site Emergency Facilities: Well equipped Emergency room in the clinic</p>\n<p>\n KAVI-ICR Kangemi site Number of Staff: 1 physician, I pharmacist, 2 pharmacy staff, 2 trial clinicians, 3 nurse counselors, 2 community staff, 1 data IT/Data manager, 3 Data staff and 8 lab staff, I labaratory Manager Site Facities: Clinic, Labaratory, data and Pharmacy space available on site Emergency Facities: Well equiped Emergecy room in the clinic</p>\n<p>\n SWOP University of Nairobi, Number of Staff: 1 physician, I pharmacist, 5 pharmacy staff, 4 trial clinicians, 6 nurse counselors, 2 community staff, 1 data IT/Data manager, 1 Data staff and 8 lab staff, I labaratory Manager Site Facilities: Clinic, Labaratory and data space available Site Emergency Facilities: Well equipped Emergency room in the clinic</p>\n<p>\n KEMRI Centre for microbiology research (CMR) Lumumba –Kisumu Co-Investigators 2 ,Co-I & Pharmacist of Record 1 ,Study Medical Doctors 2 ,Study Clinicians 2 ,Study Coordinator 1 Laboratory Manager 1 ,Laboratory Technologists 4 ,Community Liaison/Retention officer 1 , Research Ethics & Regulatory officers 3 ,Study Nurses 8 ,Data Manager 1 ,Data Analyst 1 ,Data Clerks 4 ,Community Trackers 10 ,Receptionists 2 ,Research Scientist 1 ,Administrators 2 ,Finance Manager 1 Site Facilities: Clinic, Labaratory and data space available Site Emergency Facilities: Well equipped Emergency room in the clinic</p>\n<p>\n KEMRI /Walter Reed (WRP) –Kericho Site Principal Investigator (PI),Associate Investigator (AI),Research Study Pharmacist,Clinical Research Staff Site Facities: Clinic, Labaratory, data and Pharmacy space available site Emergency Facities: Well equiped Emergecy room in the clinic</p>\n<p>\n KEMRI –Centre for Clinical Research Butere (CCR) Clinical Officers – 6; Study Nurses – 6, Laboratory Manager – 1,Laboratory Technologist-5, ICT and Data Manager/Administrative staff– 1,6. Data Clerks – 4,7. Regulatory Affairs-1,8. Community Field Personnel-7 Site Facities: Clinic, Labaratory, data and Pharmacy space available site Emergency Facities: Well equiped Emergecy room in the clinic</p>\n<p>\n KIRDO- Kenya Impact Research and Development Organisation Clinical Research Site Principal Investigator and Site Leader, Co-Principal Investigator and Clinical Lead, Pharmacist of Records (PoR), Study Coordinator, Assistant Study Coordinator, Associate Pharmacist,Laboratory Manager, Community Liaison Manager, Regulatory Affairs Officer, Study Clinician, Study Collaborator, Site Facities: Clinic, Labaratory, data and Pharmacy space available site Emergency Facities: Well equiped Emergecy room in the clinic</p>\n<p>\n VIBRI- Victoria Biomedical Research Institute –Kisumu Site Principal Investigator (PI),Sub-Investigator (AI),Clinical Research Coordinator, Clinicians, Study Nurses, Community Relations and Field Team Site Facities: Clinic, Labaratory, data and Pharmacy space available site Emergency Facities: Well equiped Emergecy room in the clinic</p>\n
      • other_details_explanation<p>\n No</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationEach study participant will followed up for 365 days
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_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_countriesNo
      • multiple_member_states
      • number_of_sites8
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site2000
      • total_participants_worldwide40000
      • 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_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyAdolescents
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProf Omu Anzala
      • investigator1_middle_name
      • investigator1_family_nameAnzala
      • investigator1_qualificationMBChB, PhD
      • investigator1_professional_addressP.O box 19676
      • investigator1_telephone+254 727 555279
      • investigator1_emailoanzala@kaviuon.org
      • organisations_transferred_No
      • number_participants20000
      • notification
      • approval_date23-05-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted30-03-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe queries from the reviewers have been answered
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-09-19 15:48:19
      • created2022-03-14 11:07:30
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id802
        • application_id1131
        • given_nameAyallo, John Mark O,
        • middle_name
        • family_nameAYALLO
        • qualificationMB,ChB; MPH; PGCs
        • professional_addressImpact Research & Development Organization K-IRDO –KISUMU
        • telephone +254 722847249
        • emailayallo@impact-rdo.org
        • created2022-03-14 11:15:16
        • modified2022-03-30 09:50:40
      • 1(array)
        • id804
        • application_id1131
        • given_nameProf KAWANGO AGOT
        • middle_name
        • family_nameAGOT
        • qualificationPh.D., MPH, MPhil
        • professional_addressImpact Research & Development Organization P.O. Box 9171, Kisumu, Kenya
        • telephone254-(0)736-505046 / (0)723-511113 / (0)57-2020132
        • emailE-mail address: kawango@impact- rdo.org / mamagift
        • created2022-03-14 12:03:24
        • modified2022-03-30 09:50:40
      • 2(array)
        • id805
        • application_id1131
        • given_nameDR. LUCAS TINA OTIENO
        • middle_name
        • family_nameOTIENO
        • qualificationMBChB MPH
        • professional_addressVIBRI- VICTORIA BIOMEDICAL RESEARCH INSTITUTE –KISUMU
        • telephone+254 720597654
        • emailltina@vibriafrica.org
        • created2022-03-14 12:03:24
        • modified2022-03-30 09:50:40
      • 3(array)
        • id806
        • application_id1131
        • given_nameDR.MARICIANA ONONO
        • middle_name
        • family_nameONONO
        • qualificationMBChB; MSc,PhD
        • professional_addressKEMRI-CENTRE FOR MICROBIOLOGY RESEARCH (CMR) LUMUMBA –KISUMU
        • telephone +254 732390992
        • emailmaricianah@gmail.com
        • created2022-03-14 12:03:24
        • modified2022-03-30 09:50:40
      • 4(array)
        • id807
        • application_id1131
        • given_nameDR.JANET OYIEKO
        • middle_name
        • family_nameOYIEKO
        • qualificationMD; MMed
        • professional_addressKEMRI –CENTRE FOR CLINICAL RESEARCH BUTERE (CCR)
        • telephone+254 721996988
        • emailjanet.oyieko@gmail.com
        • created2022-03-14 12:03:24
        • modified2022-03-30 09:50:40
      • 5(array)
        • id809
        • application_id1131
        • given_nameDR.Fredrick Kipyego Sawe
        • middle_name
        • family_nameSAWE
        • qualificationMBChB, MMed
        • professional_addressKEMRI/WALTER REED –KERICHO
        • telephone +254 703247902
        • emailFredrick.Sawe@usamru-k.org
        • created2022-03-14 12:03:24
        • modified2022-03-30 09:50:40
      • 6(array)
        • id810
        • application_id1131
        • given_nameDR. MICHAEL M MUTUA
        • middle_name
        • family_nameMutua
        • qualificationMBChB
        • professional_addressKAVI-Institute of Clinical Research KNH Site University of Nairobi, P.O Box 19676 Nairobi-00202
        • telephone+254 0724653138
        • emailMMutua@kaviuon.org
        • created2022-03-14 12:03:24
        • modified2022-03-30 09:50:40
      • 7(array)
        • id811
        • application_id1131
        • given_nameDr Joshua Kimani
        • middle_name
        • family_nameKIMANI
        • qualificationMBChB MPH Diploma
        • professional_addressSWOP University of Nairobi, P.O Box 19676 Nairobi-00202
        • telephone +254 715684509
        • emailJkimani@csrtkenya.org
        • created2022-03-14 12:03:24
        • modified2022-03-30 09:50:40
      • 8(array)
        • id812
        • application_id1131
        • given_nameDR. IRENE A. MUGENYA
        • middle_name
        • family_nameMUGENYA
        • qualificationMBChB
        • professional_addressKAVI-Institute of Clinical Research KANGEMI Site University of Nairobi, P.O Box 19676 Nairobi-00202
        • telephone+254 715474373
        • emailImugenya@kaviuon.org
        • created2022-03-14 12:03:24
        • modified2022-03-30 09:50:40
    • SiteDetail(array)
      • 0(array)
        • id1257
        • application_id1131
        • county_id47
        • site_nameSWOP
        • physical_addressUNIVERSITY OF NAIROBI
        • contact_detailsP.O Box 19676 Nairobi-00202
        • contact_personDR JOSHUA KIMANI
        • site_capacity(null)
        • misc(null)
        • created2022-03-14 11:15:16
        • modified2022-03-30 09:50:40
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1259
        • application_id1131
        • county_id42
        • site_name K-IRDO –KISUMU
        • physical_addressKenya-Impact Research and Development Organization, Tuungane Hospital, Mito Jura Road, next to Kibuye Catholic Church, Kisumu, Kenya
        • contact_detailsKenya-Impact Research and Development Organization, P.O. Box 7738-40100, Kisumu, Kenya
        • contact_personDR. MARK AYALLO & PROF.KAWANGO
        • site_capacity(null)
        • misc(null)
        • created2022-03-14 20:40:54
        • modified2022-03-30 09:50:40
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1260
        • application_id1131
        • county_id42
        • site_nameVIBRI- VICTORIA BIOMEDICAL RESEARCH INSTITUTE –KISUMU
        • physical_addressVIBRI- VICTORIA BIOMEDICAL RESEARCH INSTITUTE –KISUMU SUB COUNTY HOSPITAL
        • contact_details0720597654
        • contact_personDR. LUCAS TINA
        • site_capacity(null)
        • misc(null)
        • created2022-03-14 20:43:16
        • modified2022-03-30 09:50:40
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 3(array)
        • id1261
        • application_id1131
        • county_id42
        • site_nameKEMRI-CENTRE FOR MICROBIOLOGY RESEARCH (CMR) LUMUMBA –KISUMU
        • physical_addressLUMUMBA SUB COUNTY HOSPITAL
        • contact_details0732390992
        • contact_personDR.M.ONONO
        • site_capacity(null)
        • misc(null)
        • created2022-03-14 20:50:04
        • modified2022-03-30 09:50:40
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 4(array)
        • id1262
        • application_id1131
        • county_id37
        • site_nameKEMRI –CENTRE FOR CLINICAL RESEARCH BUTERE(CCR)
        • physical_addressKEMRI CCR - BUTERE COUNTY HOSPITAL
        • contact_details0721996988
        • contact_personDR.JANET OYIEKO
        • site_capacity(null)
        • misc(null)
        • created2022-03-14 20:51:14
        • modified2022-03-30 09:50:40
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
      • 5(array)
        • id1263
        • application_id1131
        • county_id35
        • site_nameKenya Medical Research Institute/Walter Reed Project (KEMRI/WRP)
        • physical_addressHospital Road PO Box 1357-20200 Kericho, KENYA
        • contact_detailsTel Office: (+254 5220) 36000/100 Fax (+254 5220) 30546 / 30662
        • contact_personDR.FREDRICK SAWE
        • site_capacity(null)
        • misc(null)
        • created2022-03-14 20:58:02
        • modified2022-03-30 09:50:40
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 6(array)
        • id1266
        • application_id1131
        • county_id47
        • site_nameUNIVERSITY OF NAIROBI- KAVI- KANGEMI
        • physical_addressKAVI-Institute of Clinical Research KANGEMI Site University of Nairobi,
        • contact_detailsP.O Box 19676 Nairobi-00202
        • contact_personDR. IRENE A. MUGENYA
        • site_capacity(null)
        • misc(null)
        • created2022-03-14 20:58:02
        • modified2022-03-30 09:50:40
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 7(array)
        • id1267
        • application_id1131
        • county_id47
        • site_nameUNIVERSITY OF NAIROBI- KAVI- KNH
        • physical_addressKAVI-Institute of Clinical Research KNH Site University of Nairobi,
        • contact_detailsP.O Box 19676 Nairobi-00202
        • contact_personDR. MACHAEL MUTUA
        • site_capacity(null)
        • misc(null)
        • created2022-03-14 21:09:37
        • modified2022-03-30 09:50:40
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id584
        • application_id1131
        • sponsorWorld Health Organisation (WHO )and the Ministry of Health
        • sponsor_typeOthers
        • contact_personDr Ana Maria Henao Restrepo
        • addressWorld Health Organization 20 Avenue Appia 1211 Geneva 27 Switzerland
        • telephone_number+41 22 791 3402
        • fax_number
        • cell_number+41795130039
        • email_addresshenaorestrepoa@who.int
        • created2022-03-14 11:15:16
        • modified2022-03-30 09:50:40
  • 2(array)
    • Application(array)
      • id764
      • user_id81
      • trial_status_id7
      • abstract_of_study<p>\n  </p>\n<p style=\"margin: 0px 0px 8px; text-align: justify; line-height: 115%;\">\n <span lang=\"EN-US\" style=\"margin: 0px; line-height: 115%; font-size: 12pt;\"><font color=\"#000000\" face=\"Times New Roman\">Pneumonia is the leading infectious cause of death among children. Inpatient mortality among children with severe pneumonia often exceeds 10%. For more than 30 years, World Health Organization (WHO) guidelines have recommended empirical treatment with a combination of injectable benzylpenicillin or ampicillin plus gentamicin for children at the highest risk of mortality (severe pneumonia). There is growing debate over the appropriateness of the current recommendations for empirical treatment. The first key question this trial seeks to address is whether either injectable amoxicillin-clavulanic acid or ceftriaxone is superior to benzylpenicillin or ampicillin plus gentamicin (standard care) for the treatment of children hospitalised with severe pneumonia. </font></span></p>\n<p style=\"margin: 0px 0px 8px; text-align: justify; line-height: 115%;\">\n <span lang=\"EN-US\" style=\"margin: 0px; line-height: 115%; font-size: 12pt;\"><font color=\"#000000\" face=\"Times New Roman\">Some authorities advise against enteral nutrition in severely ill patients, citing concerns of compromised respiratory status and increased risk of aspiration with nasogastric feeding. Evidence to support these concerns is lacking. Further, administration of intravenous fluids demands careful monitoring - a common challenge in many low resource settings. Intravenous fluids are also deficient in nutritive value to match the raised metabolic demands associated with acute illness. The second key question is therefore whether nasogastric feeding is superior to intravenous fluid therapy for supportive management of children with severe pneumonia.</font></span></p>\n<p style=\"margin: 0px 0px 8px; text-align: justify; line-height: 115%;\">\n <span lang=\"EN-US\" style=\"margin: 0px; line-height: 115%; font-size: 12pt;\"><font color=\"#000000\" face=\"Times New Roman\">This 3x2 factorial pragmatic randomised controlled trial will aim to recruit 4392 children aged 2-59 months at up to ten hospitals in Kenya, two in Tanzania, and one in Uganda by competitive enrolment. The primary endpoint will be mortality at Day 5 post-enrolment. Secondary outcomes will be length of hospitalisation, time taken to be able to drink, adverse effects related to the antibiotic treatments, and mortality at Day 30. </font></span></p>\n<p style=\"margin: 0px 0px 8px; text-align: justify; line-height: 115%;\">\n <span lang=\"EN-US\" style=\"margin: 0px; line-height: 115%; font-size: 12pt;\"><font color=\"#000000\" face=\"Times New Roman\">A more detailed analysis of aetiology and outcomes will be performed on a sub-population of 500 children randomly selected from sites in Kenya representing high and low malaria transmission regions. This sub-study will involve obtaining chest radiographs, collection of nasopharyngeal samples to test for viral pathogens (Respiratory syncytial virus subtypes A and B and Adenovirus), and clinical assessment three months after recruitment. </font></span></p>\n<p style=\"margin: 0px 0px 8px; text-align: justify; line-height: 115%;\">\n <span lang=\"EN-US\" style=\"margin: 0px; line-height: 115%; font-size: 12pt;\"><font color=\"#000000\" face=\"Times New Roman\">The study questions being tackled have been identified as research priorities by policy makers at the Ministry of Health in Kenya, WHO and UNICEF. We therefore anticipate the rapid translation of the findings to policy and clinical practice in settings where the burden of pneumonia is highest.</font></span></p>\n<p>\n  </p>\n
      • study_title<p>\n Supportive Care and Antibiotics for Severe Pneumonia among Hospitalised Children </p>\n
      • laymans_summary<h4>\n Study Title</h4>\n<p>\n A study to compare different injectable antibiotic treatments and different modes of fluid treatment for children with severe pneumonia.</p>\n<h4>\n What is the problem?</h4>\n<p>\n Pneumonia, an infection of the lungs, is one of the leading causes of death among young children. World Health Organization (WHO) has recommendations for the diagnosis and treatment of pneumonia in low- and middle-income countries using simple clinical features and low cost, widely available antibiotics. The recommend treatment for children at the highest risk of death (severe pneumonia) is injectable benzyl penicillin or ampicillin and gentamicin. Following the introduction of vaccines against the main causes of pneumonia to national immunisation programmes in many low-income countries, there has been growing debate over the appropriateness of the currently recommended treatments. Many clinicians already believe that the recommended treatment is ineffective and frequently opt to use other antibiotics such as amoxicillin-clavulanic acid and ceftriaxone instead. We need a study to determine which antibiotics are best.</p>\n<p>\n  </p>\n<p>\n Children with severe pneumonia are typically not able to eat food and so standard practice is to try and continue some form of fluid and energy intake during the serious illness. Some authorities advise against feeding through a tube inserted into the stomach through the nose in severely ill children. The main reason for this is are the potential for affecting the ability to breath in a patient already experiencing difficulty breathing and an increased risk of choking on feeds given through the tube. However, the alternative, providing fluids through an intravenous drip, requires careful monitoring by a nurse to ensure the fluid is given at a safe rate over the desired duration. If fluids drip in too fast this may itself cause breathing problems. This a common challenge in many low resource settings where a limited number of nursing staff are required to attend to several duties. Fluids provided through a drip also lack the necessary nutrients to match the increased demands of the body during a serious illness. We plan to carry out a study comparing the different antibiotics and approaches to feeding/fluid management described above.</p>\n<h4>\n What questions are we trying to answer?</h4>\n<p>\n Current data suggest that more than 10% of children with severe pneumonia die and we are trying to find better ways of treating them to reduce this. We want to find out (1) which antibiotics are the most effective for the treatment of children admitted to hospital with severe pneumonia, and (2) whether feeding through a tube inserted into the stomach through the nose is more effective than providing fluids through a drip inserted in a vein for the management of children with severe pneumonia.</p>\n<h4>\n Where is the study taking place, how many people does it involve and how are they selected?</h4>\n<p>\n The study will take place at up to 10 hospitals in Kenya, one in Uganda and one in Tanzania. A total of 4392 children aged 2 – 59 months will be allocated to the study treatment groups through a balanced process that ensures each child has a fair chance of receiving any given study treatments. Each of the two questions will be studied in the same set of patients. Thus, a child recruited in the study will receive any one of the three antibiotic treatments and either an intravenous drip for fluids or tube feeding into the stomach. For each of the study questions, we will compare the percentage of children who die within the first five days of recruitment in the alternative treatment groups. We will also compare the length of hospitalisation, time taken to be able to drink, any adverse effects that may be related to the antibiotic treatments, and the percentage of children who die within 30 days of recruitment in the different treatment groups. In a smaller group of children at selected sites, we will also study the causes of pneumonia by performing chest X-rays and studying samples collected from the nose, and the long-term outcomes of the illness by assessing the same group of children 3 months after recruitment.</p>\n<h4>\n What does the study involve for those who are in it?</h4>\n<p>\n A member of the study team will seek initial permission from the caregiver to include their child in the study. This initial permission will allow children to be provisionally enrolled into the study without delaying the initiation of emergency treatment. The study clinician will interview the caregiver and examine each child after which he/she will prescribe one of the three antibiotic treatments and either an intravenous fluid drip or tube feeding, allocated through a random process. Children will be reviewed daily by the study team, working together with the hospital staff to provide the best care available in the hospital. Further detailed written permission will be sought by the study clinician once the child has stabilised during which additional information on the study will be provided. Children will be followed up during the hospital stay and for 30 days after enrolment through a phone call or a face-to-face visit at the hospital, depending on the alternative that is more convenient and feasible for the caregiver. We will perform a chest X-ray and collect a sample from the nose in a small group of patients who will be followed up for three months after enrolment to better understand the causes and long-term effects of severe pneumonia.</p>\n<h4>\n What are the benefits and risks/costs of the study for those involved? </h4>\n<address>\n The antibiotics that will be given in the study are already regularly used routinely in hospitals and the doctor in charge of the care for children in the hospital (not the study doctor) will be able to alter the treatment they receive if they feel it is in the child’s best interest. Some of the side effects that have been associated with them include: loss of appetite, stomach discomfort, diarrhoea, vomiting, skin rash and very rarely an allergic reaction. Some pain and discomfort will be experienced from the initial injection used to insert the drip that will then be used to give the antibiotics and intravenous fluids but this is a common part of existing practice. There is also a small risk of bruising, infection or leakage of the drip at the site of injection. Children who are assigned to receive feeds through a tube in the nose may experience discomfort during insertion of the tube but this is also a common part of existing practice. There is a small risk of the tube being placed in the wrong location or displaced resulting in choking. Children who are selected for collection of samples from the nose may experience brief discomfort during the procedure. The injection/drip insertion and administration of intravenous treatments, feeding tube insertion and checking for position before each use and collection of samples from the nose will all be done by experienced healthcare professionals, following the study protocols for these procedures. Parents/guardians of patients who we are unable to contact via telephone will be requested to return to the hospital on a specified date at least 30 days after enrolment with their children. Reimbursement for out-of-pocket costs associated with taking part will be provided at each scheduled visit, based on KEMRI Wellcome Trust Research Programme guidelines.</address>\n<h4>\n How will the study benefit society? </h4>\n<p>\n Since pneumonia is the leading cause of hospitalisation in Kenya, Uganda, Tanzania, and other countries in the region, the findings from this research will directly inform policy on the appropriate care of a substantial number of sick children with the hope of reducing child mortality.</p>\n<h4>\n When does the study start and finish?</h4>\n<address>\n The study aims to start as soon as ethical approval is obtained. Recruitment of participants is expected to continue for about two years. We expect to report the final results within one year of competing follow up of the final study participant.</address>\n<p>\n  </p>\n<p>\n  </p>\n
      • short_titleSEARCH
      • protocol_noECCT/19/05/03
      • version_no1.1
      • date_of_protocol20-01-2019
      • study_drugBenzylpenicillin, Ampicillin, Gentamicin, Ceftriaxone, Amoxicillin-clavulanic acid
      • disease_conditionSevere Pneumonia
      • 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_nameBenzylpenicillin, Ampicillin, Gentamicin, Ceftriaxone, Amoxicillin-clavulanic acid, Intravenous Fluids (Ringer\'s Lactate with 5% Dextrose and Normal (0.9%)Saline with 5% Dextrose)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • 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_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Ambrose Agweyu
      • declaration_date131-03-2019
      • declaration_principal_investigatorDr Ambrose Agweyu
      • declaration_date231-03-2019
      • placebo_presentNo
      • study_objectives<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Primary Objectives: </span></span></p>\n<p>\n <span style=\"font-family: arial, helvetica, sans-serif;\">The SEARCH trial aims to determine whether: </span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">(i) Mortality is reduced within five days when treated with either ceftriaxone or intravenous amoxicillin/clavulanic acid, compared to currently recommended benzyl penicillin or ampicillin and gentamicin.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">(ii) Mortality is reduced within five days when enteral nutrition is administered via the nasogastric route as immediate supportive therapy, compared to intravenous maintenance fluids.</span></span></p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Inclusion Criteria </p>\n<p style=\"margin: 4px 0px 0px 60px; text-align: justify; text-indent: -18pt;\">\n Age 2 to 59 months </p>\n<p style=\"margin: 4px 0px 0px 60px; text-align: justify; text-indent: -18pt;\">\n History of cough or difficulty breathing and signs of pneumonia based on WHO criteria</p>\n<p style=\"margin: 4px 0px 0px 60px; text-align: justify; text-indent: -18pt;\">\n Admitted to any one of the study hospitals</p>\n<p style=\"margin: 4px 0px 0px 60px; text-align: justify; text-indent: -18pt;\">\n Informed consent provided by the parents/guardian  </p>\n<p style=\"margin: 4px 0px 0px 60px; text-align: justify; text-indent: -18pt;\">\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n Exclusion Criteria</p>\n<p>\n  </p>\n<p style=\"margin: 4px 0px 0px 48px; text-align: justify; text-indent: -18pt;\">\n <font color=\"#000000\"><span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">Children presenting in cardiorespiratory arrest requiring emergency basic life support (bag-valve-mask ventilation and/or chest compressions).</span></font></p>\n<p style=\"margin: 0px 0px 0px 48px; text-align: justify; text-indent: -18pt;\">\n <font color=\"#000000\"><span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">Children for whom concurrent condition precludes the use of the first-line antibiotics for severe pneumonia such as readmission or meningitis</span></font></p>\n<p style=\"margin: 0px 0px 0px 48px; text-align: justify; text-indent: -18pt;\">\n <font color=\"#000000\"><span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">Shock due to dehydration or severe dehydration (based on WHO definitions </span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\"><span style=\"margin: 0px;\">(5)</span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">) requiring emergency fluid resuscitation </span></font></p>\n<p style=\"margin: 0px 0px 0px 48px; text-align: justify; text-indent: -18pt;\">\n <font color=\"#000000\"><span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or amoxicillin-clavulanic acid.</span></font></p>\n<p style=\"margin: 0px 0px 0px 48px; text-align: justify; text-indent: -18pt;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\"><font color=\"#000000\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></font></span></span><span lang=\"EN-US\" new=\"\" style=\"margin: 0px; color: black; line-height: 115%; font-family: \" times=\"\">Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the first-line regimen is considered to have failed </span></p>\n<p style=\"margin: 0px 0px 0px 48px; text-align: justify; text-indent: -18pt;\">\n <font color=\"#000000\"><span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">Previously enrolled in the study.</span></font></p>\n<p style=\"margin: 0px 0px 0px 48px; text-align: justify; text-indent: -18pt;\">\n <font color=\"#000000\"><span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">For Randomisation 2 (IV fluid versus nasogastric feeds): children with absent gag reflex.</span></font></p>\n<p style=\"margin: 0px 0px 0px 48px; text-align: justify; text-indent: -18pt;\">\n <font color=\"#000000\"><span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">For Randomisation 2 (IV fluid versus nasogastric feeds): children unable to maintain oxygen saturations </span><span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\">³</span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">90% on pulse oximetry while receiving supplemental oxygen.</span></font></p>\n<p style=\"margin: 0px 0px 0px 48px; text-align: justify; text-indent: -18pt;\">\n <font color=\"#000000\"><span style=\"margin: 0px; line-height: 115%; font-family: Symbol; font-size: 12pt;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span new=\"\" style=\"margin: 0px; line-height: 115%; font-family: \" times=\"\">For Randomisation 2 (IV fluid versus nasogastric feeds): children with severe acute malnutrition</span></font></p>\n<p>\n  </p>\n
      • primary_end_points<p>\n  </p>\n<p style=\"margin: 0px; text-align: justify; line-height: 115%;\">\n <span lang=\"EN-US\" style=\"margin: 0px; line-height: 115%; font-size: 12pt;\"><font color=\"#000000\" face=\"Times New Roman\">(i) Mortality  five days post-enrollment when treated with either ceftriaxone or intravenous amoxicillin/clavulanic acid, compared to currently recommended benzyl penicillin or ampicillin and gentamicin.</font></span></p>\n<p style=\"margin: 0px; text-align: justify; line-height: 115%;\">\n <span lang=\"EN-US\" style=\"margin: 0px; line-height: 115%; font-size: 12pt;\"><font color=\"#000000\" face=\"Times New Roman\">(ii) Mortality five days post-enrollment when enteral nutrition is administered via the nasogastric route as immediate supportive therapy, compared to intravenous maintenance fluids.</font></span></p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:150px;\">\n <p>\n <strong>Site </strong></p>\n </td>\n <td style=\"width:150px;\">\n <p>\n <strong>Name </strong></p>\n </td>\n <td style=\"width:150px;\">\n <p>\n <strong>Qualification(s)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Kiambu County Referral Hospital, Kenya l</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Lydia Thuranira</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB</p>\n <p>\n MMed Paediatrics and Child Health.</p>\n <p>\n Certificate in Protection of Human Subjects in Research </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Machakos County Referral Hospital, Kenya</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Charles Nzioki.</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB</p>\n <p>\n MMed Paediatrics and Child Health.</p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Embu County Referral Hospital, Kenya</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Esther Njiru</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB</p>\n <p>\n MMed Paediatrics and Child Health.</p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Naivasha District Hospital, Kenya</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Angeline Ithondeka</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB</p>\n <p>\n MMed Paediatrics and Child Health.  </p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Bungoma County Referral Hospital, Kenya</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Felicitas Makokha</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB</p>\n <p>\n MMed Paediatrics and Child Health.</p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Kitale County Referral Hospital, Kenya</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Rachel Inginia</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB</p>\n <p>\n MMed Paediatrics and Child Health.</p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Kisumu East Hospital, Kenya</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Magdaline Kuria</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB</p>\n <p>\n MMed Paediatrics and Child Health.  </p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Kakamega County Referral Hospital, Kenya</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Peter Aduro</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB</p>\n <p>\n MMed Paediatrics and Child Health.</p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Busia County Referral Hospital, Kenya</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Emma Namulala</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB</p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Mama Lucy Kibaki Hospital.</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Celia Muturi</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MBChB.</p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Jinja Regional Referral Hospital, Uganda</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Emmanuel Tenywa           </p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MD, MPH</p>\n <p>\n <span style=\"display: inline !important; float: none; background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">Certificate in Protection of Human Subjects in Research </span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Bugando Medical Centre, Tanzania</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n Dr Adolfine Hokororo</p>\n </td>\n <td style=\"width:150px;\">\n <p>\n MD</p>\n <p>\n MMed Paediatrics and Child Health</p>\n <p>\n MSc Clinical Epidemiology and Health Systems Research.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n The study sites are “District” and/or “County level” hospitals with basic emergency facilities and the capability to provide primary and referral services.</p>\n<p>\n the proposed trial is based on a pragmatic design. The study will hire one Clinical Officer (CO) and one data clerk at each site who will both receive direct supervison from the hospital paediatrician (site PI) and the central trial management team led by the study PI. </p>\n<p>\n All hospital staff attending to study participants will undergo training in WHO inpatient case management guidelines for Severe pneumonia. Further training will also be provided on consenting procedures, data collection and SOP for direct clinical care.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n Tanzania Food and Drugs Authority, Tanzania (submission pending)</p>\n<p>\n  </p>\n<p>\n National Drugs Authority, Uganda (submission pending)</p>\n
      • other_details_regulatory_approved<p>\n Tanzania Food and Drugs Authority, Tanzania - one site (submission pending)</p>\n<p>\n  </p>\n<p>\n National Drugs Authority, Uganda - one site (submission pending)</p>\n
      • other_details_regulatory_rejected<p>\n N/A </p>\n
      • other_details_regulatory_halted<p>\n N/A </p>\n
      • estimated_durationEnrollment and follow-up will take place over a period of 2 years. Analysis will be conducted upon completion of participant recruitment.
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specify 3x2 factorial design
      • design_controlled_comparatorEfficacy of 3 Injectable
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifySupportive care Interventions: Intravenous Fluid (Ringers Lactate with 5% dextrose or normal (0.9%) saline solution with 5% dextrose )
      • 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_sites10
      • multi_country_listUganda \nTanzania
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment. Minimum number per site- 200 Maximum number per site-800
      • total_participants_worldwide4392
      • 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_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyThe participants are children aged 2 to 59 months. They will require consent from their parent(s)/primary care-giver/guardian.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameAmbrose
      • investigator1_middle_name
      • investigator1_family_nameAgweyu
      • investigator1_qualificationPhd
      • investigator1_professional_addressHealth services Unit-KEMRI Welcome Trust Research Programme 197 Lenana Place, Lenana Road P.O Box 43640-00100 Nairobi, Kenya
      • investigator1_telephone+254722619257
      • investigator1_emailaagweyu@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants3660
      • notification<p>\n Current status of the trial: Not yet recruiting</p>\n
      • approval_date21-07-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-02-2020
      • 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)
      • modified2025-02-07 08:53:03
      • created2019-02-26 07:30:42
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id473
        • application_id764
        • given_nameAmbrose
        • middle_name
        • family_nameAgweyu
        • qualificationPhD
        • professional_addressHealth services Unit-KEMRI Welcome Trust Research Programme 197 Lenana Place, Lenana Road P.O Box 43640-00100 Nairobi, Kenya
        • telephone+254722619257
        • emailaagweyu@kemri-wellcome.org
        • created2019-02-26 07:44:19
        • modified2020-02-27 07:13:36
    • SiteDetail(array)
      • 0(array)
        • id600
        • application_id764
        • county_id47
        • site_nameMama Lucy Kibaki Hospital
        • physical_addressSpine Road, Umoja 3, Nairobi
        • contact_detailsP.O Box 34349 00100 Nairobi
        • contact_personDr Celia Muturi
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 07:44:19
        • modified2020-02-27 07:13:36
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id601
        • application_id764
        • county_id22
        • site_nameKiambu County Referral Hospital
        • physical_addressKiambu Town
        • contact_detailsP.O Box 39-00900, Kiambu
        • contact_personDr Lydia Thuranira
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 08:09:14
        • modified2020-02-27 07:13:36
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 2(array)
        • id602
        • application_id764
        • county_id16
        • site_nameMachakos County Referral Hospital
        • physical_addressMachakos Town
        • contact_detailsP.O Box 19-90100, Machakos, info@machakoshospital.org
        • contact_personDr Charles Nzioki
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 08:09:14
        • modified2020-02-27 07:13:36
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 3(array)
        • id603
        • application_id764
        • county_id14
        • site_nameEmbu County Referral Hospital
        • physical_addressEmbu township
        • contact_detailsP.O Box 33-60100, Embu, embupgh@winnet.co.ke, +254-722-406-595
        • contact_personDr Esther Njiru
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 08:09:14
        • modified2020-02-27 07:13:36
        • County(array)
          • id14
          • county_nameEmbu
          • created2012-06-15 10:23:42
          • modified2012-06-15 10:23:42
      • 4(array)
        • id604
        • application_id764
        • county_id32
        • site_nameNaivasha County Hospital
        • physical_addressGreat North Road, Naivasha
        • contact_detailsP.O Box 141-20117, Naivasha, admin@naivashahealth.or.ke, +254-770-735-546
        • contact_personDr Angeline Ithondeka
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 08:09:14
        • modified2020-02-27 07:13:36
        • County(array)
          • id32
          • county_nameNakuru
          • created2012-06-15 10:25:52
          • modified2012-06-15 10:25:52
      • 5(array)
        • id605
        • application_id764
        • county_id39
        • site_nameBungoma County Referral Hospital
        • physical_addressMoi Avenue, Bungoma, bungomahospital@yahoo.com
        • contact_detailsP.O Box 14-50200, Bungoma
        • contact_personDr Felicitas Makokha
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 08:09:14
        • modified2020-02-27 07:13:36
        • County(array)
          • id39
          • county_nameBung\'oma
          • created2012-06-15 10:26:45
          • modified2012-06-15 10:26:45
      • 6(array)
        • id606
        • application_id764
        • county_id40
        • site_nameBusia County Referral Hospital
        • physical_addressMjini sublocation, Busia Township
        • contact_detailsP.O Box 87-50400, Busia , busiahoispital@gmail.com, +254-722-429-821
        • contact_personDr Emma Namulala
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 08:09:14
        • modified2020-02-27 07:13:36
        • County(array)
          • id40
          • county_nameBusia
          • created2012-06-15 10:26:51
          • modified2012-06-15 10:26:51
      • 7(array)
        • id607
        • application_id764
        • county_id26
        • site_nameKitale County Referral Hospital
        • physical_addressNaisambu, Kitale Town
        • contact_detailsP.O Box 98, Kitale, dmoh@kitale.yahoo.com
        • contact_personDr Rachel Inginia
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 08:09:14
        • modified2020-02-27 07:13:36
        • County(array)
          • id26
          • county_nameTrans Nzoia
          • created2012-06-15 10:25:05
          • modified2012-06-15 10:25:05
      • 8(array)
        • id608
        • application_id764
        • county_id42
        • site_nameKisumu East Hospital
        • physical_addressPaul Mbuya Road (Opposite Kisumu Sports Ground), Kisumu
        • contact_detailsP.O Box 1818-40100, Kisumu
        • contact_personDr Magdaline Kuria
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 08:09:14
        • modified2020-02-27 07:13:36
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 9(array)
        • id609
        • application_id764
        • county_id37
        • site_nameKakamega County Referral Hospital, Kenya
        • physical_addressKakamega Town between Kakamega police divisional headquarters and Kakamega administrative headquarters
        • contact_detailsP.O Box 15-50100, Kakamega
        • contact_personDr Peter Aduro
        • site_capacity(null)
        • misc(null)
        • created2019-02-26 08:09:14
        • modified2020-02-27 07:13:36
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
    • Sponsor(array)
      • 0(array)
        • id369
        • application_id764
        • sponsorUniversity of Oxford
        • sponsor_typeOthers
        • contact_personDirector of Research Services
        • addressCentral Admin - Research Services University of Oxford Wellington Square Oxford OX1 2JD United Kingdom
        • telephone_number+44 1865 270000
        • fax_number
        • cell_number+44 1865 270000
        • email_addressoxtrec@admin.ox.ac.uk
        • created2019-02-26 07:44:19
        • modified2020-02-27 07:13:36
  • 3(array)
    • Application(array)
      • id1189
      • user_id60
      • trial_status_id7
      • abstract_of_study<p>\n <strong>Background:</strong> Yellow fever (YF) is a viral disease transmitted by a mosquito; the Aedes aegypti and Haemagogous species mosquitoes, during the rainy season. This disease is endemic in the tropical and subtropical areas in South America and Africa.  Vaccination is the most important means of preventing the infection. There are other approved vaccines for YF but the uptake has not been adequate due to vaccine shortage as a result of available vaccine stock being diverted to preventive campaigns; this has significantly affected the supply to immunization programs and the global supply for travelers too. WHO reports a total of 47 countries, including 34 from Africa and 13 from Central and South America, endemic for YF. As per WHO, the estimated number of severe cases in both continents is 84,000-170,000, with approximately 29,000-60,000 deaths annually. The outbreaks are necessitating an urgent response. In such an event, a global shortage of YF vaccine is not uncommon. This has given rise to evaluation of measures to counter this shortage such as fractional dosing of YF vaccines.</p>\n<p style=\"margin-left:-.25pt;\">\n <strong>Purpose and rationale:</strong> The vaccine supply is still a major obstruction These low YF vaccination coverages indicate the presence of an underlying susceptible population at risk of YF and a risk of continued transmission. Hence, SIIPL has developed this Yellow Fever Vaccine to address this issue of yellow fever vaccine shortage. SIIPL has developed a Yellow Fever vaccine which contains the same 17D-213 vaccine strain used in already licensed and WHO prequalified vaccines.  </p>\n<p style=\"margin-left:-.25pt;\">\n <strong>Objective:</strong> To demonstrate the non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL^® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT₅₀).</p>\n<p>\n <strong>Methodology:</strong> The study will be conducted in Kenya at the KEMRI CRDR Clinical Research Annex- Nairobi. The expected study duration is approximately 24months, individual participation will be approximately 7months. Healthy male or female volunteers aged ≥ 1 to < 60 years will be divided into three age groups of ≥ 1 to < 10 years, ≥ 10 to < 18 years and ≥ 18 to < 60 years and into the immunogenicity and reactogenicity cohort for the three age groups. They will be randomized in the ratio of 3:2 to receive the allocated IP. A total of 2280 participants will be enrolled; Nairobi site will recruit at least 1140 participants. A single dose of either SII-YFV or STAMARIL^® will be administered subcutaneously to the study participants. There will be three scheduled visits during the study.  A screening and vaccination visit (Day 0) followed by additional study visits on Day 28 and on Day 180 post-vaccination. Prior to enrolment participants will be taken through consenting and will sign assent/consent; only eligible participants will be enrolled into the study.</p>\n<p style=\"margin-left:-.25pt;\">\n <strong>Expectation: </strong>The current Phase III study is designed to demonstrate the non-inferiority in terms of the seroconversion rates achieved with SII YF vaccine versus STAMARIL. This study will support prequalification by the WHO for global application. This will improve YF vaccination coverages and reduce susceptibility of populations at risk of YF and a risk of continued transmission.</p>\n
      • study_title<p>\n YWF:03: A PHASE III, MULTICENTER, DOUBLE BLIND, RANDOMIZED STUDY OF SII YELLOW FEVER VACCINE TO COMPARE SAFETY AND IMMUNOGENICITY WITH STAMARIL^®</p>\n<p>\n  </p>\n
      • laymans_summary<p>\n Yellow fever is a viral disease spread by a mosquito during the rainy season. This disease is widespread in the tropical and subtropical areas in South America and Africa. The important prevention measure is vaccination. There are other approved vaccination for YF but the uptake is not satisfactory as a result of vaccine shortage, this is because the available vaccines stocks are sidetracked to preventive campaigns which has affected the supply of this vaccine to the immunization program and the global supply for travelers too. WHO reports a total of 47 countries, including 34 from Africa and 13 from Central and South America; YF is widespread in these regions.. As per WHO, the estimated number of serious cases in both continents is 84,000-170,000, with approximately 29,000-60,000 deaths annually. The outbreaks are necessitating an urgent response. There are a limited number of manufacturers of YF vaccine. In such an event, a global shortage of YF vaccine is not uncommon. This has given rise to evaluation of measures to counter this shortage such as fractional dosing of YF vaccines. The vaccine supply is still a major obstruction; these low YF vaccination coverages indicate the presence of populations facing the danger of YF and a danger of continued transmission. Hence, SIIPL has developed this Yellow Fever Vaccine to address this issue of   YF vaccine shortage. SIIPL has developed a YF vaccine which contains the same 17D-213 vaccine strain used in already licensed and WHO prequalified vaccines. The objective of this study is to demonstrate that the immune responses generated by SII-YFV are equal or more effective as compared to STAMARIL^® .The study will be conducted in Kenya at the KEMRI CRDR Clinical Research Annex- Nairobi. The expected study duration is approximately 24months, individual participation will be approximately 7months. Healthy male or female volunteers aged ≥ 1 to < 60 years will be divided into three age groups of ≥ 1 to < 10 years, ≥ 10 to < 18 years and ≥ 18 to < 60 years and into the immunogenicity and reactogenicity cohort for the three age groups. They will be randomized in the ratio of 3:2 to receive the allocated either SII-YFV or STAMARIL. A total of 2280 participants will be enrolled in to the study in Kenya; Nairobi site will recruit at least 1140 participants. A single dose of either SII-YFV or STAMARIL^® will be administered subcutaneously to the study participants. There will be three scheduled visits during the study.  A screening and vaccination visit (Day 0) followed by additional study visits on Day 28 and on Day 180 post-vaccination. Prior to enrolment participants will be taken through consenting and will sign assent/consent as applicable; only eligible participants will be enrolled into the study. The results of this study will support prequalification by the WHO for global application. This will improve YF vaccination coverages and reduce contact of populations at danger of YF and a risk of continued transmission.</p>\n
      • short_titleYWF:03
      • protocol_noECCT/22/11/04
      • version_no3.1
      • date_of_protocol07-10-2022
      • study_drugSII Yellow Fever Vaccine
      • disease_conditionYellow Fever
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameN/A
      • product_type_medical_device_nameN/A
      • comparatorYes
      • comparator_nameStamaril
      • comparator_registeredYes
      • comparator_countriesMost countries globally; WHO prequalified
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvnduba@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_countries(null)
      • 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_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Julius Kiuri
      • declaration_date130-11-2022
      • declaration_principal_investigatorDr. Videlis Nduba
      • declaration_date230-11-2022
      • placebo_presentNo
      • study_objectives<div>\n <strong>Primary Objective</strong></div>\n<div>\n To demonstrate the non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT50).</div>\n<div>\n  </div>\n<div>\n <strong>Secondary Objectives </strong></div>\n<div>\n •<span style=\"white-space:pre\"> </span>To compare the YF NAb geometric mean titres (GMTs) generated following SII-YFV to those generated following STAMARIL®. </div>\n<div>\n •<span style=\"white-space:pre\"> </span>To determine the impact of pre-existing flavivirus antibodies on YFV immunogenicity. </div>\n<div>\n •<span style=\"white-space:pre\"> </span>To compare the safety and tolerability of SII-YFV to STAMARIL®.  </div>\n<div>\n  </div>\n
      • principal_inclusion_criteria<ol>\n <li>\n Male or female volunteers aged ≥ 1 to < 60 years </li>\n <li>\n Healthy volunteers as determined by medical history and clinical examination </li>\n <li>\n Participants willing to adhere to the protocol requirements and to provide informed consent for participants ≥ 18 years of age. For participants < 18 years of age, parental/guardian ability and willingness to provide informed consent (as per local requirements/procedures) and additional informed assent from participants, as appropriate for participating community (i.e. participants at least 7 years of age in Kenya)</li>\n <li>\n Intend to remain residing in study area throughout the study participation</li>\n <li>\n Female participants of childbearing potential* must have practiced adequate contraception** and agree to continue adequate contraception till Day 28 post-vaccination. </li>\n</ol>\n<p style=\"margin-left:27.5pt;\">\n *Females can be considered not of childbearing potential only if they are pre-menarche and less than 12 years of age, or with current bilateral tubal ligation or occlusion, or posthysterectomy, or post-bilateral ovariectomy, or post-menopause.</p>\n<p style=\"margin-left:27.5pt;\">\n **Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label as follows:</p>\n<ul>\n <li>\n Abstinence from penile-vaginal intercourse, when this is the preferred and usual lifestyle</li>\n <li>\n Combined estrogen and progesterone oral contraceptives</li>\n <li>\n Injectable progestogen</li>\n <li>\n Implants of etonogestrel or levonorgestrel</li>\n <li>\n Contraceptive vaginal ring</li>\n <li>\n Percutaneous contraceptive patches</li>\n <li>\n Intrauterine device or intrauterine system</li>\n <li>\n Male partner (sole partner for participant) sterilized</li>\n <li>\n Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository), and/or progesterone alone oral contraceptive</li>\n</ul>\n<ol>\n <li value=\"6\">\n Female participants of childbearing potential must have a negative pregnancy test within 24 hours prior to IP administration.</li>\n <li value=\"7\">\n Be willing to avoid the use of traditional/herbal local medications and treatments for the duration of the study  </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Fever (<u>></u> 37.5°C) or any clinically significant acute infection at time of vaccination [Temporary exclusion criteria – participants may be re-screened at least 48 hours after the last recorded fever]</li>\n <li>\n Use of systemic (oral or parenteral) antibiotics or antiviral agents within the past 7 days. [Temporary exclusion criteria – participants may be re-screened at least 7 days after last dose of antibiotics or antiviral agents]</li>\n <li>\n Use of traditional/herbal local medications and treatments in the past 7 days [Temporary exclusion criteria – participants may be re-screened at least 7 days after last consumption of traditional/herbal local medications and treatment]</li>\n <li>\n Previous history of laboratory confirmed infection with yellow fever and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.</li>\n <li>\n Previous vaccination against yellow fever, TBE, JE, or dengue fever.</li>\n <li>\n Receipt of any vaccine within past 28 days or planned vaccination until completion of Day 28 visit</li>\n <li>\n Known or suspected impairment of immunological function based on medical history and physical examination.</li>\n <li>\n Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant’s health or is likely to result in nonconformance to the protocol</li>\n <li>\n History of chronic administration (defined as more than 14 consecutive days) of immunosuppressant (> 0.5 mg/kg/day of prednisolone or equivalent) or other immune modifying drugs including the use of glucocorticoids. The use of topical/inhaled/per nasal glucocorticoids will be permitted.</li>\n <li>\n A known hypersensitivity to any of the vaccine components (including gelatin, eggs, egg products, or chicken protein) or history of a life-threatening reaction to any past vaccine.</li>\n <li>\n Receipt of any immunoglobulin therapy and / or blood products in the past 60 days or planned administration until completion of Day 28 visit.</li>\n <li>\n Participation in a drug research study, involving investigational products, within past 3 months or planned participation during the entire study period</li>\n <li>\n Receipt of any investigational or unlicensed medication (drug or vaccine) in the preceding 28 days, or planned use until completion of Day 28 visit</li>\n <li>\n Uncontrolled coagulopathy or blood disorder contraindicating subcutaneous injections or blood sampling</li>\n <li>\n Be an employee of, or direct descendant (child or grandchild) of any person employed by the investigator or sponsor.</li>\n <li>\n Pregnant or lactating women</li>\n <li>\n Requirement of Yellow Fever vaccination certificate for travelling purpose</li>\n <li>\n History of thymus dysfunction including myasthenia gravis, thymoma, thymectomy</li>\n <li>\n History or presence of significant alcoholism or drug abuse in the past one year</li>\n <li>\n Major congenital or genetic defect</li>\n <li>\n Any other condition which in the opinion of the investigator will jeopardize the safety of the participant or compromise the assessment of the study objectives</li>\n</ol>\n
      • primary_end_points<div>\n Percentage seroconversion* on Day 28 post-vaccination</div>\n<div>\n  </div>\n<div>\n *Seroconversion is defined as a four-fold rise in YF NAb (PRNT₅₀) titres from baseline</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • 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 KEMRI-CRDR</p>\n<p>\n Site staff include the principal investigator, 3 medical officers, 3 pharmacists, 1 pharm tech, 5 nurses, 9 lab personnel, 5 quality assurance officers, 4 clinical officers, 3 administrators and 12 community health workers.</p>\n<p>\n This facility has several clinical rooms available for consenting, nursing procedures, clinical exams and dosing. There are also additional facilities that include 3 bed male and female inpatient ward for admission when required, staff work areas, a monitoring space, a pharmacy, a conference board room, a laboratory and kitchen for preparing participant meals.</p>\n<p>\n VIBRI</p>\n<div>\n The trial site and its satellites have the capacity to conduct this trial to the highest international standards in accordance with Good Clinical Practice (GCP) and Human Subjects Protection requirements. The trial site has the human resources, pharmacy and laboratory infrastructure, clinical examination rooms, data entry rooms with good internet services, monitoring space and office space for work and meetings.</div>\n
      • other_details_explanation<ul>\n <li>\n N/A</li>\n <li>\n Study is conducted in Kenya. Due to the lower Yellow Fever incidence in India, it is not feasible for sample size reasons to conduct a Phase III Trial in this nation.</li>\n <li>\n Consequently the study will be conducted in a high incidence African nation.</li>\n</ul>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 Months
      • 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_comparatorStamaril
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyActive Comparator
      • 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_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteAt least 912 in each site
      • total_participants_worldwide1824
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyFor children (≥1 year to < 18 years of age), consent to participate in the study will be requested from parents or guardians.
      • investigator1_given_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMBChB, MPH, PhD
      • investigator1_professional_addressP.O. Box 47855-00100, Nairobi KEMRI-CRDR KNH Complex, Off Hospital Road
      • investigator1_telephone+254724522474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participants1824
      • notification
      • approval_date26-02-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted30-11-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer comments have been responded to.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-12 07:21:43
      • created2022-11-19 12:53:18
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id865
        • application_id1189
        • given_nameVidelis
        • middle_name
        • family_nameNduba
        • qualificationMBChB, MPH, PhD
        • professional_addressP.O. Box 47855-00100, Nairobi KEMRI-CRDR KNH Complex, Off Hospital Road
        • telephone+254724522474
        • emailvnduba@gmail.com
        • created2022-11-19 13:09:22
        • modified2022-11-30 19:14:48
      • 1(array)
        • id866
        • application_id1189
        • given_nameOtieno
        • middle_name
        • family_nameWalter
        • qualificationMBChB, MMed(Paed), PhD
        • professional_addressP.O. Box 47855-00100, Nairobi KEMRI-CRDR, KNH Complex, Off Hospital Road
        • telephone+254724522474
        • emailvnduba@gmail.com
        • created2022-11-24 14:19:12
        • modified2022-11-30 19:14:48
    • SiteDetail(array)
      • 0(array)
        • id1333
        • application_id1189
        • county_id47
        • site_nameKEMRI-CRDR
        • physical_addressKEMRI/CRDR Clinical Research Annex - KENYATTA NATIONAL HOSPITAL OFF HOSPITAL ROAD P.O BOX 47855-00100 NAIROBI-KENYA
        • contact_detailsP.O. Box 47855, NAIROBI 00100, Kenya, Tel: (020) 2724262/4/5
        • contact_personDr Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2022-11-19 13:09:22
        • modified2022-11-30 19:14:48
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1337
        • application_id1189
        • county_id42
        • site_nameVictoria Biomedical Research Institute (VIBRI)
        • physical_addressKisumu County Referral Hospital Off Ang’awa Road
        • contact_detailsP.O Box 7180-40100 Kisumu, Kenya Email: info@vibriafrica.org Tel: +254 (0) 720 597 654
        • contact_personDr. Lucas Otieno Tina
        • site_capacity(null)
        • misc(null)
        • created2022-11-30 18:45:48
        • modified2022-11-30 19:14:48
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id615
        • application_id1189
        • sponsorSerum Institute of India Pvt Ltd
        • sponsor_typeIndustry
        • contact_personDr Sajjad Desai
        • address212/2, Soli Poonawalla Road, Hadapsar. Pune. 411028, India
        • telephone_number +91-20-26993900
        • fax_number+ 91-20-26993945
        • cell_number +91-20-26993900
        • email_addresssajjad.desai@seruminstitute.com
        • created2022-11-19 13:09:22
        • modified2022-11-30 19:14:48
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_confirmatory1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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