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  • 1Recruiting
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  • 8Writing-up
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• applications(array)
  • 0(array)
    • Application(array)
      • id1131
      • user_id71
      • trial_status_id7
      • 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)
      • 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_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
  • 1(array)
    • Application(array)
      • id201
      • user_id89
      • trial_status_id(null)
      • abstract_of_study<div>\n Visceral leishmaniasis is a systemic disease that is fatal if left untreated and worldwide</div>\n<div>\n causes an estimated 50,000 deaths annually. In East Africa Visceral leishmaniasis</div>\n<div>\n frequently causes large-scale tenacious epidemics with high case-fatality rates (CFRs).</div>\n<div>\n For most of the past 70 years, the therapeutic armoury for treatment of leishmaniasis has</div>\n<div>\n been extremely limited. Pentavalent antimonials were introduced in the 1940s. Use of</div>\n<div>\n amphotericin B followed after a few decades, and was later joined by paromomycin, a</div>\n<div>\n cheap and effective parenteral drug with an acceptable toxicity profile that can easily be</div>\n<div>\n given by intramuscular injection. Finally, different lipid formulations of amphotericin B</div>\n<div>\n (i.e. liposomal amphotericin B , Ambisome ) have been developed, which are similar to</div>\n<div>\n amphotericin B in efficacy but with fewer toxic effects.</div>\n<div>\n The development of miltefosine, the only drug at present that can be given orally for the</div>\n<div>\n treatment of visceral leishmaniasis, has been a major breakthrough. Dafra Pharma</div>\n<div>\n Research and Development intends to develop and commercialize a new and promising</div>\n<div>\n alkylphosphocholine, oleylphosphocholine (OlPC), which is a derivative of miltefosine as</div>\n<div>\n a new oral drug for the treatment of leishmaniasis.</div>\n<div>\n The chemical structures of two alkylphosphocholines, oleylphosphocholine and</div>\n<div>\n miltefosine are as shown below. The key difference between the two</div>\n<div>\n alkylphosphocholines is that OLPC has a double bond in the alkyl chain that miltefosine</div>\n<div>\n does not have.</div>\n<div>\n  </div>\n<div>\n <div>\n Oleylphosphocholine presents an efficacy profile similar or superior to the one of</div>\n <div>\n miltefosine in various experimental models, but has the advantage of showing a wider</div>\n <div>\n therapeutic window compared to miltefosine translating into a better tolerance and</div>\n <div>\n possible increased compliance to treatment, but it has not been administered to human in a</div>\n <div>\n controlled clinical study.</div>\n</div>\n<div>\n Objectives</div>\n<div>\n The primary objective is to estimate initial safety and tolerability of oleylphosphocholine</div>\n<div>\n in healthy male volunteers.</div>\n<div>\n The secondary objective is to obtain data on pharmacokinetics following oral</div>\n<div>\n administration of oleylphosphocholine in human.</div>\n<div>\n Methods</div>\n<div>\n This protocol is intended to evaluate whether a rising dose of oleylphosphocholine,</div>\n<div>\n administered orally in fasting condition, is well tolerated and safe in man. The protocol</div>\n<div>\n uses 3 cohorts of 10 volunteers receiving a dose of 50, 100 or 150mg (on Day 0) of</div>\n<div>\n oleylphosphocholine randomly allocated to the participants. The volunteers will also be</div>\n<div>\n sampled for pharmacokinetic purposes.</div>\n<div>\n Utility of results</div>\n<div>\n This protocol is made for a first in man study of the compound oleylphosphocholine.</div>\n<div>\n Single dose escalating, open Phase 1 trial in healthy male volunteers to evaluate the</div>\n<div>\n safety, tolerability and the pharmacokinetics of oleylphosphocholine. The drug is</div>\n<div>\n developed to become a treatment for Leishmaniasis in Africa. The results are intended to</div>\n<div>\n be used to develop a phase-II study on the study.</div>\n<div>\n In case the criteria for halting the study are not met at the end of the study, i.e. after all 30</div>\n<div>\n volunteers have received their allocated study dose, tolerability beyond the intended</div>\n<div>\n therapeutic dose might be explored to gain experience regarding target organs of toxicity</div>\n<div>\n in case of intoxication during clinical use, or to allow higher doses for Phase II studies, if necessary.</div>\n<div>\n  </div>\n
      • study_title<p>\n Single Dose Escalating, Single-blind Phase 1 Trial in Healthy Male Volunteers to Evalute the Safety, Tolerability and the Pharmacokinetics of Oleylphosphocholine.</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/07/05
      • version_no12
      • date_of_protocol24-06-2013
      • study_drugOleyphosphocholine
      • disease_conditionNA
      • 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_nameOleyphosphocholine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssnjoroge@kemri.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Njenga S. Njoroge
      • declaration_date105-08-2013
      • declaration_principal_investigatorDr. Rashid Juma
      • declaration_date205-08-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Healthy male, adults aged 18-45 years inclusive at the time of screening</li>\n <li>\n Weight between 45-80 Kg inclusive</li>\n <li>\n Written informed consent obtained from the participants before study start</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n HIV positive or other immunosuppresive status</li>\n <li>\n Symptomatic infection</li>\n <li>\n concomitant exposure to other investigational medicinal products</li>\n <li>\n History of alcohol or drug abuse</li>\n <li>\n Known hypersensitivity to miltefosine</li>\n <li>\n Lipid disorders, including abnormal blood levels of total cholesterol, HDL,LDL and triglycerides</li>\n <li>\n Laboratory result abnormalities including abnormal ECG, liver function tests more than three times upper limit of normal, creatinine outside normal range</li>\n <li>\n Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition or any other finding that in the opinion of the PI may increase the risk to the participant from participating in the study</li>\n <li>\n Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.</li>\n</ol>\n
      • primary_end_points<ol>\n <li>\n Identify potential dose limiting toxicity of OIPC</li>\n <li>\n Documentation of solicited symptoms after administration during a 29 day follow-up period, i.e from day 0 (day of administration) to day 28 post-administration</li>\n <li>\n Documentation of unsolicited symptoms after administration during a 29-day follow up period i.e from day 0 (day of administration) to day 28 post administration</li>\n <li>\n Documentation of the occurance of serious adverse events (SAE) throughout the study period</li>\n <li>\n Determination of the serum levels of oleylphosphocholine following oral administration.</li>\n</ol>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<div>\n The Centre for Clinical Research (CCR) at KEMRI was established in 1983 and has since grown to</div>\n<div>\n an international centre for clinical research. The facilities consist of 30 clinical beds, 10 of which are</div>\n<div>\n dedicated to Phase 1 clinical trials.</div>\n<div>\n CCR has clinical laboratories for haematology, clinical biochemistry and parasitology. The centre</div>\n<div>\n also has a full-fledged radiology Unit as well as a facility for upper-GI and lower-GI endoscopy. The</div>\n<div>\n laboratory equipments are regularly maintained and serviced. All laboratories have SOPs for</div>\n<div>\n maintenance and for running the different tests.</div>\n<div>\n In terms of personnel the centre has 6 highly qualified doctors and a clinical officer. The laboratory</div>\n<div>\n has 10 highly qualified technical employees. There is also 1 radiologist, 3 radiographers and 17</div>\n<div>\n research nurses. A pharmacy and a qualified pharmacist are also present on site.</div>\n<div>\n This study team is highly experienced in conducting complex studies and complying with ICH/GCP</div>\n<div>\n requirements. All CCR scientific, nursing and laboratory staffs are GCP/GcLP trained, and biannually undergo GCP/GcLP refresher courses.</div>\n<div>\n The team of CCR has conducted several clinical trials including Phase 1 studies.</div>\n
      • other_details_explanation<div>\n Dafra Pharma distributes its products exclusively on the African market and has always</div>\n<div>\n focused on making drugs available for the African population, where the need is high and</div>\n<div>\n drugs need to be affordable. Therefore it is ethically fair that the African population and</div>\n<div>\n scientific community, who are likely to use the medicine in clinical practice, participate in</div>\n<div>\n the clinical development. This will allow reliable and accurate data about tolerance and</div>\n<div>\n pharmacokinetics to be compiled in the target population.</div>\n<div>\n Dafra Pharma is developing the investigational drug oleylphosphocholine (OlPC) as a</div>\n<div>\n new therapeutic treatment option for visceral leishmaniasis. This neglected parasitic</div>\n<div>\n disease does not occur in the country of the sponsor (Belgium), whereas it is endemic to</div>\n<div>\n Kenya. The goal of the current Phase I study is to assess the safety and pharmacokinetic</div>\n<div>\n profile of OlPC in healthy Kenyan volunteers.</div>\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 NA</p>\n
      • estimated_durationSeven months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Centre for Clinical Research
      • single_site_physical_addressMbagathi way
      • single_site_contact_personDr. Njenga S Njoroge
      • single_site_telephone254 722 733 213
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site30
      • total_participants_worldwide30
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. Rashid
      • investigator1_middle_nameRavasco
      • investigator1_family_nameJuma
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKEMRI Centre for Clinical Research
      • investigator1_telephone254 20 2726781
      • investigator1_emailjrashid@kemri.org
      • organisations_transferred_No
      • number_participants30
      • notification
      • approval_date25-06-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted06-08-2013
      • 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)
      • modified2013-08-14 16:45:05
      • created2013-08-05 15:07:05
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id132
        • application_id201
        • given_nameRashid
        • middle_nameRavasco
        • family_nameJuma
        • qualificationMBCHB
        • professional_addressKEMRI Centre for Clinical Research
        • telephone254 20 2726781
        • emailjrashid@kemri.org
        • created2013-08-05 15:16:05
        • modified2013-08-06 13:31:23
    • SiteDetail(array)
      • 0(array)
        • id162
        • application_id201
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-08-05 15:16:05
        • modified2013-08-06 13:31:23
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id106
        • application_id201
        • sponsorDafra Pharma Research and Development
        • sponsor_type(null)
        • contact_personBruno Jansen
        • addressSlachthuisstraat 30/7, 2300 Turnhout, Belgium
        • telephone_number+32 14 47 29 98
        • fax_number
        • cell_number+32 475 422 920
        • email_addressbruno.jansen@dafra.be
        • created2013-08-05 15:16:05
        • modified2013-08-06 13:31:23
  • 2(array)
    • Application(array)
      • id1073
      • user_id336
      • trial_status_id1
      • 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
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • 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_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
      • 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 <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
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer queries have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-06-07 16:43:29
      • created2021-10-12 06:47:01
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id737
        • application_id1073
        • given_nameZahida
        • middle_name
        • family_nameQureshi
        • qualificationAssociate Professor
        • 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
    • SiteDetail(array)
      • 0(array)
        • id1137
        • application_id1073
        • county_id32
        • site_nameNakuru Level V Hospital
        • physical_addressshow ground road
        • contact_detailsP.O. Box 71-20100
        • contact_personDr. Barassa
        • site_capacity(null)
        • misc(null)
        • created2021-10-12 06:57:00
        • modified2022-02-22 07:47:28
        • County(array)
          • id32
          • county_nameNakuru
          • created2012-06-15 10:25:52
          • modified2012-06-15 10:25:52
      • 1(array)
        • 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)
        • misc(null)
        • created2021-10-12 07:10:44
        • modified2022-02-22 07:47:28
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id1139
        • application_id1073
        • county_id32
        • site_nameNaivasha Level IV Hospital
        • physical_addressNaivasha
        • contact_detailsP.O.B ox 141 Naivasha
        • contact_personDr. Chege
        • site_capacity(null)
        • misc(null)
        • created2021-10-12 07:10:44
        • modified2022-02-22 07:47:28
        • County(array)
          • id32
          • county_nameNakuru
          • created2012-06-15 10:25:52
          • modified2012-06-15 10:25:52
    • Sponsor(array)
      • 0(array)
        • 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
  • 3(array)
    • Application(array)
      • id904
      • user_id81
      • trial_status_id7
      • abstract_of_study<p>\n Severe Malaria In African Children: A Research and Trials Consortium (SMAART) was funded in 2018 by a collaboration award in science from the Wellcome Trust. Owing the continued high burden of malaria and poor outcomes of severe malaria, even on the best antimalarial, artesunate, the major objective of SMAART is to conduct better research faster across a collaborative platform to identify interventions to optimise the whole treatment pathway for children with severe malaria, and thus to achieve a step-change in improving their outcomes in the current era.</p>\n<p>\n  </p>\n<p>\n A novel new drug candidate for adjunctive treatment of severe malaria, sevuparin, has been identified that can blocks merozoite invasion, prevent cytoadherence and transiently de-sequesters infected erythrocytes in humans with uncomplicated <em>P. falciparum</em> malaria. If given, in addition to antimalarial treatment, early in the course of admission (<24 hours) this could result in improvements in outcomes from severe malaria for the subgroups at greatest risk and during the period of greatest risk (first day of hospitalisation). Sevuparin has been shown to be safe and well tolerated in adults with only some mild effects on activated partial thromboplastin time (APTT) at higher doses given over longer periods of time (3 days), which are not clinically relevant to the time of greatest risk.</p>\n<p>\n  </p>\n<p>\n In this Phase I trial dose-finding paediatric study, we aim to use only 3 doses given at admission (0 hours), and 8 and 16 hours later, and measure APTT 1 hour after each dose (to assess maximum toxicity based on adult data). The Phase I trial is designed to obtain data on safety, dosing, feasibility and potentially lactate clearance of sevuparin given as an adjuvant therapy in severe malaria in children. We aim to study 20 children admitted to hospital with severe malaria which will allow sufficient data on safety to be generated across a range of doses to identify the maximum tolerated dose (MTD) using the Continual Reassessment Method (CRM), which adapts or informs subsequent doses for each child entering the trial based on the data from previously enrolled children. The maximum tolerated dose (MTD) will be identified based on the dose-toxicity model being updated by each previous patient’s APTT results using standard methods.</p>\n<p>\n  </p>\n<p>\n The results of the Phase I trial will identify the final dosage to be tested in a Phase II trial in terms of both efficacy and safety outcomes. The primary endpoint for the future Phase II trial (lactate clearance) reflects the primary hypothesis that sevuparin improves microcirculatory flow by reversing and preventing parasite sequestration. The Phase I trial will also assess whether this endpoint, lactate clearance, is realistic; thus lactate will be collected along with other test results at baseline 4 hours and 8 hours, as well as other time points.</p>\n<p>\n  </p>\n
      • study_title<p>\n SEVUSMART TRIAL</p>\n<p>\n Sevuparin as a potential adjunctive therapy in children with severe malaria</p>\n
      • laymans_summary<p>\n  </p>\n<p>\n <strong>What is the problem/background? </strong></p>\n<p>\n Even on the best antimalarial treatments (injectable artesunate) many African children with severe malaria have poor outcomes with most deaths occurring early in the course of hospital admission (<24hours). One of the bad things that happen in severe malaria is that red blood cells that are infected with malaria parasites that stick to the very deep parts of our blood vessels. This occurs throughout the body and therefore the blood flow is poor tissues which leads to a build-up of body acids (called lactate). Up to the present there have been no treatments available to prevent or reverse stop red cells sticking to the blood vessels when they have malaria parasites in them.</p>\n<p>\n  </p>\n<p>\n The SMAART: Severe Malaria in African children: A Research and Trials consortium have identified one key innovation which could improve this. A novel new drug candidate called sevuparin, has been identified and safely tested in adults with malaria in Thailand. Sevuparin acts by preventing malaria parasites getting into red cells in the first place (this means that the malaria parasite cannot survive); it also prevents red cells with infected with malaria parasites from sticking to the blood vessels and also able to ‘unstick’ red cells with infected with malaria parasites that are already sticking to the blood vessel and causing poor blood flow.</p>\n<p>\n  </p>\n<p>\n Given its potential to be transformative in improving current outcomes from severe malaria, a large group of specialist doctors in severe malaria research and clinical trials suggested that sevuparin should be tested in children with severe malaria. They have all helped to design this clinical trial, which will be conducted on the high dependency ward in Kilifi, Kenya.</p>\n<p>\n  </p>\n<p>\n <strong>What questions are we trying to answer?</strong></p>\n<p>\n <strong>Study design</strong>: Phase I Safety and Dose Finding to assess the optimal dose of sevuparin given as a supportive therapy in severe malaria alongside of the usual antimalarial treatments to determine toxic level, adverse events and to identify the highest dose with an acceptable safety profile</p>\n<p>\n <strong>Study Population:</strong> 20 children hospitalised with severe malaria.</p>\n<p>\n  </p>\n<p>\n <strong>Sample Size:</strong> This is a Phase I trial designed to test safety and Dose Finding Trial of sevuparin as a supportive therapy in severe malaria; there is therefore no formal sample size calculation.</p>\n<p>\n  </p>\n<p>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></p>\n<p>\n The study will be carried out at Kilifi County Hospital, Kenya and plans to enroll 20 children. Children enrolled in the study will be aged 3 months to 12 years, and presenting to Kilifi County Hospital with severe malaria evidence of malaria (rapid diagnostic test positive or positive malaria slide). The carers of these children will be approached for consent and enrolment in the study. The study drug will be given on the first day of admission only alongside of usual treatments given for children with malaria.</p>\n<p>\n  </p>\n<p>\n <strong>What does the study involve for those who are in it?</strong></p>\n<ul>\n <li>\n Parental information and consent/parental assent (for emergencies when the child is too sick for full consent).</li>\n <li>\n Admission to the high dependency ward at Kilifi County Hospital.</li>\n <li>\n The sevuparin will be given as 3 infusions on the first day at study enrolment (0 hours), 8 and 16 hours following this. All other treatments for severe malaria will follow the usual guidelines</li>\n <li>\n Two groups of 2 participants will receive a dose of 1.5 mg/kg/dose with the plan to escalate to a cohort of 2 participants receiving 3mg/kg/dose and a cohort of 2 participants receiving 6.0 mg/kg/dose. The model will then inform each subsequent patient what dose they would then be assigned (between 1.5 and the maximum dose of 6.0 mg/kg/dose)</li>\n <li>\n All children will have regular (4 hourly clinical and vital sign) monitoring during the period of admission to the high dependency ward and twice daily thereafter until discharge and will be followed up to day 28. Routine blood tests will be done at admission, 8 and 24 hours and at follow up.  Additional samples will be taken to check clotting at 0, 1-hour post sevuparin infusion (i.e. 1, 9 and 17 hours) and lactate (the body acid that builds up in severe malaria) will be check regularly at admission, 4, 8 16 and 24 hours.</li>\n <li>\n The microcirculation, using a small soft probe placed on the gum of a children will be checked three times during admission.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>What are the benefits and risks/costs of the study for those involved?</strong></p>\n<p>\n <strong>Benefits:  </strong>Close monitoring of all children on the high dependency unit during admission and follow up to day 28 after discharge. Hospital bills for participants older than 5 years will be covered by the study (covering the costs for standard treatment for severe malaria and related complications).</p>\n<p>\n <strong>Risks: </strong>One potential risk of sevuparin, as it is heparin-like drug is that it increases one of the blood clotting markers. This was seen in the study in Thailand but was short lived (ie only happened for a few hours only) and did not cause any side effects. We are monitoring carefully this blood clotting marker and this will help us make decisions about whether the child receives the next dose and as we are using a continuous reassessment method to monitor toxicity this will inform the dosages for the children enrolled in the trial. </p>\n<p>\n  </p>\n<p>\n <strong>How will the study benefit society?</strong></p>\n<p>\n The study aims to improve the outcome from severe malaria. It will generate robust feasibility and safety data to support a future larger phase II trial with the aim of improving management of a vulnerable population of children and improving outcomes.</p>\n<p>\n  </p>\n<p>\n <strong>When does the study start and finish?   </strong>Once we have received ethical approval.</p>\n<p>\n Enrolment will be over 12-15 months and study will end after 2 years.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • short_titleSEVUSMART Trial
      • protocol_noECCT/20/06/05
      • version_no1.2
      • date_of_protocol08-02-2019
      • study_drugSevuparin
      • disease_conditionMalaria
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • 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_addressregulatory@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_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • 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_applicantKathryn Maitland
      • declaration_date123-06-2020
      • declaration_principal_investigatorKathryn Maitland
      • declaration_date223-06-2020
      • placebo_presentNo
      • study_objectives<p>\n The primary objective of this trial is to conduct a dose-finding study of intravenous sevuparin given in 3 doses over the first 18 hours from enrolment (within 24h of hospital admission), defining toxicity events as any APTT >2.5 upper limit of normal (ULN) (grade 3 toxicity) 1 hour after each dose to identify the maximum tolerated dose (MTD). The initial dosage (1.5 mg/kg) and the <em>a priori</em> dose-toxicity curve are based upon the results of the adult trial (where a dose of 1.5 mg/kg was associated with minimal risk of toxicity) and experimental evidence of dose-dependent efficacy i.e. inhibition of merozoite invasion and reversal of cytoadherence of infected erythrocytes [36]. Almost all adults enrolled in this trial experienced grade 2 toxicity after one or more sevuparin doses, but APTT rapidly normalized, hence the choice of grade 3 toxicity to define the MTD in this dose-finding trial.</p>\n<p>\n  </p>\n<p>\n The results of this Phase I trial will identify the final dosage selected for a subsequent Phase II that will include both efficacy and safety outcomes. The Phase II trial will be conducted by the SMAART consortium and plans to use change in lactate at 8 hours as its primary endpoint; likely secondary endpoints include neurological sequelae, day-28 and day-180 mortality, length of initial hospitalisation, re-admission to hospital, grade 3/4 and serious adverse events.</p>\n<p>\n  </p>\n<p>\n The primary endpoint for the future Phase II trial reflects the primary hypothesis that sevuparin improves microcirculatory flow by reversing and preventing parasite sequestration. Data collected in the Phase I trial will also assess whether lactate clearance at 8 hours is a realistic and feasible primary endpoint for a subsequent Phase II trial.</p>\n<p>\n  </p>\n<ol>\n <li value=\"1.1\">\n Specific Objectives</li>\n</ol>\n<p>\n To identify the maximum tolerated dose (MTD) of intravenous sevuparin as an adjunctive therapy in children with severe malaria given as three infusions at 0, 8 and 16 hours using the Continual Reassessment Method (CRM) to adapt or inform subsequent doses for each child entering the trial, based on a toxicity event defined as any APTT >2.5 upper limit of normal (ULN) 1 hour after each dose, and updating the dose-toxicity model using the previous patients’ APTT results.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<ol>\n <li>\n Aged between 3 months and 12 years admitted to the paediatric wards within the last 24h</li>\n <li>\n Current or recent evidence of <em>P. falciparum</em> malaria (slide or rapid diagnostic test (RDT) positive)</li>\n <li>\n Clinical evidence of severe malaria: impaired consciousness: coma (inability to localize painful stimulus) or prostration (inability to sit unsupported for those above 6 months) or deep breathing</li>\n <li>\n Lactate > 2 mmol/L</li>\n <li>\n Guardian or parent willing and able to provide consent</li>\n</ol>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li>\n Clinical evidence or a history of a bleeding/coagulation disorder</li>\n <li>\n A comorbidity which clinician believes has a significant risk of poor outcome e.g. malignancy, end-stage renal failure, major cardiac condition</li>\n <li>\n Thrombocytopenia (platelet count <25 x10⁹/L).</li>\n</ol>\n<p>\n  </p>\n<p>\n  </p>\n
      • primary_end_points<ul>\n <li>\n APTT>2.5xULN 1h post any sevuparin dose (grade 3 following the CTC)</li>\n</ul>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifySafety and dose finding trial.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Clinicians (5)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Professor Kathryn Maitland</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Dr. Mainga Hamaluba</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Dr. Nchafatso Obonyo</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Mohammed Bakari</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Emmanuel Omondi</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Nurses</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n We have a pool of 15 nurses in the KEMRI High dependency Unit but we will also have two dedicated trial nurses. All the nurses will be trained on the study protocol and procedures.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Dedicated trial nurses: Mwanamvua Boga and Floice Ombiso (Both are senior paediatric research nurses)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Trial Coordinator</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Hellen Mnjala</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The trial willbe conducted in the KEMRI high dependency unit.</p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The study will be conduected in Kenya in children with malaria as one of the studies under severe malaria consortium to improve outcomes of severe malaria owing to the continued severe malaria burden and poor outcomes.</span></p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n KEMRI - SERU (Scientific Ethics Review Unit) KEMRI/SERU/CGMR-C/127/3744 on 25th Feb 2019.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Imperial College Researcch Ethic Committee (ICREC) Reference number: P71159</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration18 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKilifi County Hospital
      • single_site_physical_addressBOX 9Kilifi
      • single_site_contact_personMs Hellen Mnjala
      • single_site_telephone+254731289430
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site20
      • total_participants_worldwide20
      • 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_specifyChildren aged below 12 years.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameKathryn Maitland
      • investigator1_middle_name
      • investigator1_family_nameMaitland
      • investigator1_qualificationProfessor of Paediatric Tropical Infectious Diseases (MBBS PhD)
      • investigator1_professional_addressBOX 230 KILIFI
      • investigator1_telephone+254733411022
      • investigator1_emailkathryn.maitland@gmail.com
      • organisations_transferred_No
      • number_participants20
      • notification
      • approval_date08-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-11-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-02-10 10:25:54
      • created2020-06-10 13:40:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id559
        • application_id904
        • given_nameKathryn Maitland
        • middle_name
        • family_nameMaitland
        • qualificationProfessor of Paediatric Tropical Infectious Diseases (MBBS PhD)
        • professional_addressBOX 230 KILIFI
        • telephone+254733411022
        • emailkathryn.maitland@gmail.com
        • created2020-06-10 13:44:31
        • modified2021-11-08 11:34:54
    • SiteDetail(array)
      • 0(array)
        • id781
        • application_id904
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-06-10 13:44:31
        • modified2021-11-08 11:34:54
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id434
        • application_id904
        • sponsorImperial college london
        • sponsor_typeOthers
        • contact_personJoint Research Compliance Officer
        • addressRoom 221, Medical school building, Norfolk Place, London W21PG
        • telephone_number+44 207 594 1188
        • fax_number
        • cell_number+44 207 594 1188
        • email_addressjro@ic.ac.uk
        • created2020-06-10 13:44:31
        • modified2021-11-08 11:34:54
  • 4(array)
    • Application(array)
      • id1533
      • user_id820
      • trial_status_id(null)
      • abstract_of_study<p>\n Server Migration</p>\n
      • study_title<p>\n Server Migration</p>\n
      • laymans_summary<p>\n Server Migration</p>\n
      • short_titleServer migration
      • protocol_noECCT/25/04/07
      • version_no1
      • date_of_protocol29-04-2025
      • study_drugServer Migration
      • disease_conditionServer Migration
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameServer Migration
      • product_type_medical_device_nameServer Migration
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.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_applicantserver migration
      • declaration_date129-04-2025
      • declaration_principal_investigatorserver migration
      • declaration_date229-04-2025
      • placebo_presentNo
      • study_objectives<p>\n Server Migration</p>\n
      • principal_inclusion_criteria<p>\n Server Migration</p>\n
      • principal_exclusion_criteria<p>\n Server Migration</p>\n
      • primary_end_points<p>\n Server Migration</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • 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 Server Migration</p>\n
      • other_details_explanation<p>\n Server Migration</p>\n
      • other_details_regulatory_notapproved<p>\n Server Migration</p>\n
      • other_details_regulatory_approved<p>\n Server Migration</p>\n
      • other_details_regulatory_rejected<p>\n Server Migration</p>\n
      • other_details_regulatory_halted<p>\n Server Migration</p>\n
      • estimated_duration12
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorServer Migration
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaServer Migration
      • single_site_physical_addressServer Migration
      • single_site_contact_personServer Migration
      • single_site_telephoneServer Migration
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site500
      • total_participants_worldwide10000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameServer Migration
      • investigator1_middle_name
      • investigator1_family_nameServer Migration
      • investigator1_qualificationServer Migration
      • investigator1_professional_addressServer Migration
      • investigator1_telephone0724743788
      • investigator1_emailjkiprotich@intellisoftkenya.co.ke
      • organisations_transferred_No
      • number_participants20
      • notification
      • approval_date30-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted29-04-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted29-04-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonServer Migration
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-30 14:39:51
      • created2025-04-28 20:07:09
      • total_sites2
      • ecitizen_invoice368738
    • InvestigatorContact(array)
      • 0(array)
        • id1250
        • application_id1533
        • given_nameServer Migration
        • middle_name
        • family_nameServer Migration
        • qualificationServer Migration
        • professional_addressServer Migration
        • telephone0724743788
        • emailjkiprotich@intellisoftkenya.com
        • created2025-04-29 08:11:39
        • modified2025-04-30 14:38:27
    • SiteDetail(array)
      • 0(array)
        • id1876
        • application_id1533
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2025-04-29 08:11:39
        • modified2025-04-30 14:38:27
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id824
        • application_id1533
        • sponsorServer Migration
        • sponsor_typeResearch Institution
        • contact_personjapheth kiprotich
        • addressServer Migration
        • telephone_number0724743788
        • fax_number
        • cell_number0724743788
        • email_addressjkiprotich@intellisoftkenya.com
        • created2025-04-29 08:11:39
        • modified2025-04-30 14:38:27
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $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
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      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
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    • Plugin(array)
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      • 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
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      • 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