Request History

• Restore to current request
• applications/index/page:70/sort:study_title/direction:asc
• applications/view/379
• applications/index/page:86/sort:protocol_no/direction:asc/approved:2
• applications/index/page:74/sort:protocol_no/direction:desc

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1746134289
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • page87
  • sortprotocol_no
  • directiondesc
  • approved2
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page87
    • current5
    • count502
    • prevPage(true)
    • nextPage(true)
    • pageCount101
    • order(array)
      • Application.protocol_nodesc
    • limit5
    • options(array)
      • page87
      • order(array)
        • Application.protocol_nodesc
      • sortprotocol_no
      • directiondesc
    • paramTypenamed

Post data

• Application(array)
  • approved2

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route

• keys(array)
  • 0controller
  • 1action
• options(empty)
• defaults(array)
  • plugin(null)
• template/:controller/:action/*

Sql Logs

Logs

View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id296
      • user_id38
      • trial_status_id7
      • abstract_of_study<p>\n Less than a year after Artemisinin-based combination therapies (ACTs) were recommended for the treatment of falciparum malaria, concerns about artemisinin resistance development along the Cambodian-Thai border were voiced. Artemisinin resistance has been poorly characterized, and is difficult to detect by classical laboratory approaches.  In-vitro tests have not consistently detected reduced pharmacodynamic responses to artemisinin drugs, and molecular markers conferring artemisinin resistance have not yet been determined.  This study aims to assess the degree of artemisinin resistance in adult and pediatric subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study treatments will be Artemether Lumefantrine (AL) and Dihydroartemisinin Piperaquin (DHA PPQ). In-vivo and in-vitro methodologies, including pharmacokinetic methods, will be employed. Data generated from this studywill potentially enable the identification of key markers that may assist in the early detection of resistance, and also to better understand the development of resistance to ACTs, and thus inform both local and international policy regarding ACT use.</p>\n
      • study_title<p>\n Therapeutic efficacy of dihydroartemisinin piperaquine and artemether lumefantrine for the treatment of uncomplicated malaria  in Kisumu County, Western Kenya</p>\n<p>\n Therapeutic efficacy of dihydroartemisinin piperaquine and artemether lumefantrine for the treatment of uncomplicated malaria  in Kisumu County, Western Kenya</p>\n
      • laymans_summary(null)
      • short_titleInvivo II study
      • protocol_noECCT/14/05/03
      • version_no3.3
      • date_of_protocol24-03-2014
      • study_drugArtemether Lumefantrine and Dihydroartemisinin Piperaquin
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameArtemether Lumefantrine and Dihydroartemisinin Piperaquin
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • 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_applicantVictorine Owira
      • declaration_date115-05-2014
      • declaration_principal_investigatorDr Ben Andagalu
      • declaration_date215-05-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Adult/child aged between 6 months and 65 years inclusive (minimum weight 11kg), presenting with a measured temperature of ≥37.5⁰C, or history of fever within 24 hours prior to presentation</li>\n <li>\n Mono-infection with <em>Plasmodium falciparum</em> (refer to section 7.6.11.2.1 below)</li>\n <li>\n Baseline parasitemia of 2000 - 200,000 asexual parasites/µl</li>\n <li>\n Ability to provide informed consent</li>\n <li>\n Willingness and ability to comply with the study protocol for the duration of the study</li>\n <li>\n Willingness to remain in the hospital for 3 days</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Presence of signs of severe malaria as defined in section 7.3.2.1 below</li>\n <li>\n Presence of severe anemia, defined as hemoglobin level below 6 g/dl</li>\n <li>\n Presence of mixed Plasmodium infection, or mono-infection of non-falciparum Plasmodium</li>\n <li>\n Inability to take oral medication</li>\n <li>\n History of allergy or contraindications to the study treatments</li>\n <li>\n Lactating or pregnant females</li>\n <li>\n Any condition that the investigator feels will result in an unfavorable outcome should the potential subject participate in the study</li>\n</ul>\n
      • primary_end_points<p>\n The primary study endpoint is the time to parasitaemia clearance from day 0 after treatment initiation. Parasitaemia clearance is defined as the parasitaemia disappearance at day 1, day 2 and up to day 28 after treatment</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The kombewa clinical research is well equiped to run phase I to phase IV clinical trials. It has fully equiped clinical laboratory with hematology, biochemestry, microbiology and microcopy departments. The center also has a fully equiped clinical research pharmacy with an emergency room and upto date emergency kits, consultation rooms, nursing station, document storage area, consenting rooms and briefing hall.</p>\n<p>\n The study has 7 investigators, 1 clinical research coordinator, 7 nurses, 5 laboratory personnel, 1 internal quality control personnel, 5 clinical officers, 1 pharmacyst and 3 pharm techs</p>\n
      • other_details_explanation<p>\n The study is an investigator initiated efficacy study.</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 Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration42 days per partcipant
      • 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_areaKombewa Clinical Research Center
      • single_site_physical_addressOff Kisumu Bondo road opposite Kombewa District Hospital
      • single_site_contact_personDr Ben Andagalu
      • single_site_telephone+254716004851
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site118
      • total_participants_worldwide118
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBen
      • investigator1_middle_name
      • investigator1_family_nameAndagalu
      • investigator1_qualificationMD,MSc
      • investigator1_professional_address54-40100 Kisumu, Kenya
      • investigator1_telephone+254716004851
      • investigator1_emailBen.Andagalu@usamru-k.org
      • organisations_transferred_No
      • number_participants118
      • notification
      • approval_date14-07-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-05-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-04-05 23:05:22
      • created2014-05-14 18:44:21
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id206
        • application_id296
        • given_nameBen
        • middle_name
        • family_nameAndagalu
        • qualificationMD, MSc
        • professional_address54-40100 Kisumu, Kenya
        • telephone+254716004851
        • emailBen.Andagalu@usamru-k.org
        • created2014-05-15 09:34:01
        • modified2014-05-15 13:10:42
    • SiteDetail(array)
      • 0(array)
        • id255
        • application_id296
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-05-15 09:34:01
        • modified2014-05-15 13:10:42
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id165
        • application_id296
        • sponsorDepartment of Emerging Infectious Diseases of the United States Army Medical Research Unit
        • sponsor_type(null)
        • contact_personCOL Roddney Coldren
        • address54-40100 Kisumu
        • telephone_number+254-20-272-9303
        • fax_number+254-20-271-4592
        • cell_number+254 (0)700 881955
        • email_addressrodney.coldren@usamru-k.org
        • created2014-05-15 09:34:01
        • modified2014-05-15 13:10:42
  • 1(array)
    • Application(array)
      • id294
      • user_id38
      • trial_status_id7
      • abstract_of_study<p>\n Less than a year after Artemisinin-based combination therapies (ACTs) were recommended for the treatment of falciparum malaria, concerns about artemisinin resistance development along the Cambodian-Thai border were voiced. Artemisinin resistance has been poorly characterized, and is difficult to detect by classical laboratory approaches.  In-vitro tests have not consistently detected reduced pharmacodynamic responses to artemisinin drugs, and molecular markers conferring artemisinin resistance have not yet been determined.  This study aims to assess the degree of artemisinin resistance in adult and pediatric subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study treatments will be Artemether Lumefantrine (AL) and Artesunate Mefloquine (ASMQ). In order to accurately evaluate the artemisinin derivative without the confounding influence of the partner drug, ASMQ will be sequentially administered. In-vivo and in-vitro methodologies, including pharmacokinetic methods, will be employed. Data generated from this study, both on its own and when compared to and pooled with data from similar studies that will be conducted in Ghana, Peru and Thailand, will potentially enable the identification of key markers that may assist in the early detection of resistance, and also to better understand the development of resistance to ACTs, and thus inform both local and international policy regarding ACT use.</p>\n
      • study_title<p>\n In vivo and in vitro efficacy of artemisinin combination therapy in Kisumu County, Western Kenya.</p>\n
      • laymans_summary(null)
      • short_titleInvivo I study
      • protocol_noECCT/14/05/02
      • version_no3.5
      • date_of_protocol10-02-2014
      • study_drugArtemether Lumefantrine and Artesunate Mefloquine
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameArtemether Lumefantrin and Artesunate Mefloquine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • 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_applicantVictorine Owira
      • declaration_date114-05-2014
      • declaration_principal_investigatorDr Ben Andagalu
      • declaration_date214-05-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Adult/child aged between 6 months and 65 years inclusive (minimum weight 11kg), presenting with a measured temperature of ≥37.5⁰C, or history of fever within 24 hours prior to presentation</li>\n <li>\n Mono-infection with Plasmodium falciparum (refer to section 7.6.10.2.1 below)</li>\n <li>\n Baseline parasitemia of 2000 - 200,000 asexual parasites/µl</li>\n <li>\n Ability to provide informed consent</li>\n <li>\n Willingness and ability to comply with the study protocol for the duration of the study</li>\n <li>\n Willingness to remain in the hospital for 3 days</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Presence of signs of severe malaria as defined in section 7.3.2.1 below</li>\n <li>\n Presence of severe anemia, defined as hemoglobin level below 6 g/dl</li>\n <li>\n Presence of mixed Plasmodium infection, or mono-infection of non-falciparum Plasmodium</li>\n <li>\n Inability to take oral medication</li>\n <li>\n History of allergy or contraindications to the study treatments</li>\n <li>\n Lactating or pregnant females</li>\n <li>\n Any condition that the investigator feels will result in an unfavorable outcome should the potential subject participate in the study</li>\n</ul>\n
      • primary_end_points<p>\n The primary study endpoint is the time to parasitaemia clearance from day 0 after treatment initiation. Parasitaemia clearance is defined as the parasitaemia disappearance at day 1, day 2 and up to day 28 after treatment.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The study site is well equiped to handle phase I to phase IV clinical trials. It has fully equiped clinical laboratory with functional hematology, biochemistry, microbiology and microscopy department. The site also has access to a level 2 basic science laboratory situated in the town office which is about 40 km from the research site. There is clinical pharmacy, consultation rooms, nursing station, emergency room equiped with emergency kits.</p>\n<p>\n The study has 7 investigators, 1 clinical research coordinator, 1 internal quality control personnel, 5 laboratory technologists, 1 pharmacyst, 3 pharm techs, 5 clinical officers, 7 nurses and numerous field workers</p>\n
      • other_details_explanation<p>\n The study is local investigator initiated</p>\n
      • other_details_regulatory_notapproved<p>\n Not Applicable</p>\n
      • other_details_regulatory_approved<p>\n Not Applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration42 days per partcipant
      • 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_areaKombewa Clinical Research Center
      • single_site_physical_addressOff Kisumu Bondo road opposite Kombewa District Hospital
      • single_site_contact_personDr Ben Andagalu
      • single_site_telephone+254716004851
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site118
      • total_participants_worldwide118
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBen
      • investigator1_middle_name
      • investigator1_family_nameAndagalu
      • investigator1_qualificationMD,MSc
      • investigator1_professional_address54-40100 Kisumu, Kenya
      • investigator1_telephone+254716004851
      • investigator1_emailBen.Andagalu@usamru-k.org
      • organisations_transferred_No
      • number_participants118
      • notification
      • approval_date14-07-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted14-05-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-04-03 05:48:21
      • created2014-05-14 08:50:04
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id203
        • application_id294
        • given_nameBen
        • middle_name
        • family_nameAndagalu
        • qualificationMD, MSc
        • professional_address54-40100 Kisumu, Kenya
        • telephone+254716004851
        • emailBen.Andagalu@usamru-k.org
        • created2014-05-14 08:56:10
        • modified2014-05-14 18:40:59
    • SiteDetail(array)
      • 0(array)
        • id252
        • application_id294
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-05-14 08:56:10
        • modified2014-05-14 18:40:59
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id162
        • application_id294
        • sponsorDepartment of Emerging Infectious Diseases of the United States Army Medical Research Unit
        • sponsor_type(null)
        • contact_personCOL Roddney Coldren
        • address54-40100 Kisumu
        • telephone_number+254-20-272-9303
        • fax_number+254-20-271-4592
        • cell_number+254 (0)700 881955
        • email_addressrodney.coldren@usamru-k.org
        • created2014-05-14 08:56:10
        • modified2014-05-14 18:40:59
  • 2(array)
    • Application(array)
      • id282
      • user_id81
      • trial_status_id6
      • abstract_of_study<p>\n The inherited disease sickle cell anaemia is common in Kenya where more than 4000 children are born with the condition each year. On the basis of positive data from clinical trials, an increasing number of patients with sickle cell anaemia in the North are now being treated with hydroxyurea.  No trials of hydroxyurea have been conducted in Africa where the safety and effectiveness of the drug are therefore unknown. We aim to conduct a multi-center phase I/II clinical trial to investigate the safety of hydroxyurea as a supportive treatment in children with sickle cell disease in Kenya, Angola and the DRC. In total, 450 children aged 12 months - 10 years (150 in each site) will be enrolled into the study. All will be placed on hydroxyurea and monitored closely to investigate both safety and efficacy of the drug over a 48 month period. If successful, we hope that this study will lead to a larger trial that will shape national management policies for all children born with sickle cell anaemia in Africa.</p>\n
      • study_title<p>\n REALIZING EFFECTIVENESS ACROSS CONTINENTS WITH HYDROXYUREA (REACH):  A PHASE I/II PILOT STUDY OF HYDROXYUREA FOR CHILDREN WITH SICKLE CELL ANAEMIA.</p>\n
      • laymans_summary<p>\n The inherited disease sickle cell anaemia is common in Kenya where more than 4000 children are born with the condition each year. On the basis of positive data from clinical trials, an increasing number of patients with sickle cell anaemia in the North are now being treated with hydroxyurea.  No trials of hydroxyurea have been conducted in Africa where the safety and effectiveness of the drug are therefore unknown. We aim to conduct a multi-center phase I/II clinical trial to investigate the safety of hydroxyurea as a supportive treatment in children with sickle cell disease in Kenya, Angola and the DRC. In total, 450 children aged 12 months - 10 years (150 in each site) will be enrolled into the study. All will be placed on hydroxyurea and monitored closely to investigate both safety and efficacy of the drug over a 48 month period. If successful, we hope that this study will lead to a larger trial that will shape national management policies for all children born with sickle cell anaemia in Africa.</p>\n
      • short_titleREACH Trial
      • protocol_noECCT/14/04/01
      • version_noversion 1.1
      • date_of_protocol11-03-2014
      • study_drugHydroxyurea
      • disease_conditionSickle Cell Disease
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameHydroxyurea
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantProf Thomas Williams
      • declaration_date108-04-2014
      • declaration_principal_investigatorProf Thomas Williams
      • declaration_date208-04-2014
      • placebo_presentNo
      • study_objectives<p>\n a) General objectives<br />\n To conduct an early phase clinical trial to establish whether or not hydroxyurea could potentially provide both a safe and effective option for the management of children living with SCA in the African context. If no major safety concerns are revealed in this early phase trial it is anticipated that this trial will be followed with a larger, definitive, late-phase trial investigating safety and efficacy in a broad range of hospital settings in Africa.<br />\n b) Specific objectives<br />\n i) To monitor the safety of hydroxyurea therapy, specifically documenting significant haematological toxicities (cytopaenias) and infections.<br />\n ii) To evaluate the benefits of hydroxyurea therapy, using both laboratory (i.e. fetal haemoglobin and haemoglobin concentrations and white blood cell counts) and clinical parameters (such as pain, hospitalization and growth parameters).<br />\n iii) To investigate the feasibility of hydroxyurea dose-escalation on laboratory and clinical parameters.<br />\n iv) To explore the pharmacokinetic and genetic basis for any observed inter-patient variability in the clinical or laboratory response to hydroxyurea<br />\n vi) To evaluate the economic cost of providing hydroxyurea therapy in the REACH study sites.</p>\n
      • principal_inclusion_criteria<ol>\n <li>\n Children 2-10 years of age who attend the children's Sickle Cell Disease Clinics (with a diagnosis confirmed by haemoglobin electrophoresis) at trial sites and who volunteer to participate in the trial</li>\n <li>\n Weight at least 10kg at the time of enrolment</li>\n <li>\n A stated willingness to comply with all study-related treatments, evaluations and follow-up</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Parent, guardian, or child unable or unwilling to provide written informed consent or verbal assent</li>\n <li>\n The presence of one or more of the known medical conditions:\n <ul>\n <li>\n acute or chronic infectious disease,</li>\n <li>\n HIV, or</li>\n <li>\n malignancy</li>\n </ul>\n </li>\n <li>\n Acute or chronic severe malnutrition based on WHO standards</li>\n <li>\n Haematological criteria at screening:\n <ul>\n <li>\n Hb<4.0g/dl</li>\n <li>\n Hb<6.0g/dl plus absolute reticulocyte count (ARC)<100x10^⁹/l</li>\n <li>\n reticulocytopaenia (ARC<80+Hb<7.0g/dl)</li>\n <li>\n thrombocytopaenia (platelets<80x10^⁹/l</li>\n <li>\n neutropaenia (<1.0x10^⁹/l)</li>\n </ul>\n </li>\n <li>\n Hydroxyurea treatment within the previous 6 months</li>\n</ol>\n
      • primary_end_points<p>\n This is primarily a safety study and the primary end points will therefore be the development of a range of toxicities measured both clinically and haematologically.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifytherapeutic exploratory
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Total staff: 6</p>\n<ol>\n <li>\n Professor Thomas Neil Williams MBBS PHD- Site PI</li>\n <li>\n Mr George Mochamah Clinical Officer- Patient Recruitment</li>\n <li>\n Esther KIvaya--Trial Monitor</li>\n <li>\n Dr Jimmy Shangala BPharm- Trial Pharmacist</li>\n <li>\n Mr Emmanuel Mabibo Diploma in Community Development- Clinical Assistant</li>\n <li>\n Ms Maurine Maoni Clinical Officer- Patient Recruitment & followup</li>\n</ol>\n
      • other_details_explanation<p>\n Hydroxyurea is already used as an established treatment for Sickle Cell Disease in the Unites States of America. The aim of this study is to see whether it can also be used safely and effectively in the context of Africa.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Cincinnati Children's Hospital Institutional Review Board, final approval 23rd December 2013. One site per country in four countries including Kenya. (Mbale Uganda-RECRC IN-COM 133/2014, Monkole, Congo-Nref: 001/CEFA-MOnkole/CEL/2019)</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration18 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKilifi County Hospital
      • single_site_physical_addressHospital Grounds, Off Bofa Road, Kilifi, Kenya
      • single_site_contact_personProfessor Thomas Neil Williams
      • single_site_telephone+254733411021
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listAngola\nDemocratic Republic of Congo\nKenya\nUganda
      • data_monitoring_committeeYes
      • total_enrolment_per_site150
      • total_participants_worldwide600
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren <18 years of age
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameRussell
      • investigator1_middle_name
      • investigator1_family_nameWare
      • investigator1_qualificationMD, PhD Paediatric Haematology/Oncology
      • investigator1_professional_addressDivision of Haematology, Cincinnati Children\'s Hospital, Cincinnati, Ohio, USA
      • investigator1_telephone513-636-4266
      • investigator1_emailrussell.ware@cchmc.org
      • organisations_transferred_No
      • number_participants150
      • notification<p>\n REACH uses commercially available hydroxyurea manufactured by Bristol Myers Squib.</p>\n<p>\n The study has been going on for the last 4 and a half years in all the 4 sites. </p>\n
      • approval_date07-07-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-09-25 14:20:58
      • created2014-03-10 10:01:25
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id196
        • application_id282
        • given_nameThomas
        • middle_nameNeil
        • family_nameWilliams
        • qualificationMBBS DCH DTM&H MRCP PhD Professor of Heamoglobinopathy Research, Imperial College London Honorary Consultant Paediatrician
        • professional_addressKEMRI/Wellcome Trust Research Programme PO Box 230-80108 Kilifi Kenya
        • telephone+254 41 7522063
        • emailtom.n.williams@gmail.com
        • created2014-03-10 12:36:53
        • modified2020-03-27 12:32:22
    • SiteDetail(array)
      • 0(array)
        • id242
        • application_id282
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-03-10 12:36:53
        • modified2020-03-27 12:32:22
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id155
        • application_id282
        • sponsorCincinnati Children\'s Hospital
        • sponsor_typeResearch Institution
        • contact_personProf Russell Ware
        • addressDivision of Haematology, Cincinnati Children\'s Hospital, Cincinnati, Ohio, USA
        • telephone_number513-636-4266
        • fax_number
        • cell_numberNone
        • email_addressrussell.ware@cchmc.org
        • created2014-03-10 12:36:53
        • modified2020-03-27 12:32:22
  • 3(array)
    • Application(array)
      • id258
      • user_id126
      • trial_status_id6
      • abstract_of_study<p>\n Atrial fibrillation (AF) is the most common cardiac arrhythmia of clinical significance, and is an important independent risk factor for cardiogenic thromboembolic events. Oral anticoagulant therapy is highly effective for prevention of stroke in patients with atrial fibrillation. Vitamin K antagonists (VKA) have been the standard of care over the last decades.</p>\n<p>\n Rivaroxaban is a potent and selective direct Factor Xa (FXa) inhibitor and, in contrast to VKAs, can be given as fixed oral dosing without need for routine coagulation monitoring.</p>\n<p>\n This non-interventional study is a prospective observational cohort study of patients with non-valvular atrial fibrillation who are prescribed Rivaroxaban, 15 mg and 20 mg tablets under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.</p>\n<p>\n  Inclusion criteria is Female and Male patients, who are at least 18 years of age with a diagnosis of non valvular atrial fibrillation, who consent  to participate in the study will be enrolled after the decision for a pharmacologic prophylaxis with Rivaroxaban within approved indication per country to prevent stroke or non-CNS systemic embolism has been made.</p>\n<p>\n  Patients will be followed up for 1 year or until 30 days after end of Rivaroxaban therapy in case therapy was discontinued earlier than 12 months.</p>\n<p>\n Each patient per site, treated to prevent stroke or non-CNS systemic embolism, must be consecutively screened and documented in a patient log file. No patient specific data will be documented in the patient log file.</p>\n<p>\n Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with Rivaroxaban to prevent stroke or non-CNS systemic embolism, and who consent to participate in the study. Prior anticoagulation therapy will be recorded in the CRF. All contra-indications according to the local marketing authorization should be considered. The main goal of this non-interventional study is to confirm the known safety profile of Rivaroxaban in clinical practice use.</p>\n<p>\n The end of the study will be reached 12 months after enrolment has ended.</p>\n
      • study_title<p>\n XANTUS-EL, Xarelto on prevention of stroke and non-central nervous system systemic embolism in patients with non valvular atrial fibrillation - a non interventional study, XA 1206 (IMPACT No. 16691)</p>\n<p>\n  </p>\n
      • laymans_summary(null)
      • short_titleRivaroxaban on prevention of stroke and non-central nervous system systemic embolism in patients with non valvular atrial fibrillation
      • protocol_noECCT/14/03/02
      • version_no1.2
      • date_of_protocol16-11-2012
      • study_drugXarelto
      • disease_conditionPrevention of stroke and non-CNS systemic embolism in non-valvular atrial fibrillation
      • 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_nameRivaroxaban
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjohn.mwangi@bayer.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_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 John Mwangi
      • declaration_date104-03-2014
      • declaration_principal_investigatorDr Eva Wainaina
      • declaration_date204-03-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Female and male patients at least 18 years of age witha a diagnosis of non-vulvular atrial fibrillation who consent.</p>\n
      • principal_exclusion_criteria<p>\n Age below 18 years; anyone who does not meet inclusion criteria</p>\n
      • primary_end_points<p>\n - Major bleeding events as defined in the protocol</p>\n<p>\n - Adverse events and serious adverse events</p>\n<p>\n - All cause mortality</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Number of staff: 6</p>\n<p>\n - 4 MBChB, MMed, Cardiology; - 2 MBChB: Dr. Hussein Gin, Dr. M. Noorani, Dr. M Warshow, Dr. N. Sheikh, Dr. P. Omondi, Dr. Rajiv Patel</p>\n<p>\n 6 nurses, 3 cardiac technicians</p>\n<p>\n Cardiac Laboratory</p>\n<p>\n Hospital Lab/ facilities</p>\n
      • other_details_explanation<p>\n A similar study the Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonist for the prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study was conducted to evaluate the efficacy and safety of rivaroxaban compared to the VKA warfarin in the prevention of thromboembolic events in subjects with non-valvular AF was conducted in the host country.</p>\n<p>\n The main goal of this non-interventional study (NIS) is to confirm the known safety profile of rivaroxaban in clinical practice use in Latin America, Eastern Europe, Middle East and Africa.</p>\n
      • other_details_regulatory_notapproved<p>\n n/a</p>\n
      • other_details_regulatory_approved<p>\n EMA, Russia</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration12 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states10
      • number_of_sites3
      • multi_country_listEastern Europe, Middle East, Africa and Latin America
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide6500
      • 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_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameWarshow
      • investigator1_middle_nameMajid
      • investigator1_family_nameMbarak
      • investigator1_qualificationM.Med
      • investigator1_professional_address20708-00200 Nairobi
      • investigator1_telephone+254722412201
      • investigator1_emailchubaone@gmail.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date16-11-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-03-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-01-07 01:23:48
      • created2014-01-21 12:30:37
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id190
        • application_id258
        • given_nameWarshow
        • middle_nameMajid
        • family_nameMbarak
        • qualificationM.Med
        • professional_address20708-00200 Nairobi
        • telephone+254722412201
        • emailchubaone@gmail.com
        • created2014-01-21 12:35:01
        • modified2014-03-11 17:10:09
    • SiteDetail(array)
      • 0(array)
        • id237
        • application_id258
        • county_id47
        • site_nameMP Shah Hospital
        • physical_addressParklands
        • contact_details20708-00200, Nairobi
        • contact_personDr Majid M. Warshow
        • site_capacity(null)
        • misc(null)
        • created2014-01-21 12:35:01
        • modified2014-03-11 17:10:09
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id149
        • application_id258
        • sponsorBayer Healthcare AG Berlin
        • sponsor_type(null)
        • contact_personEva Wainaina
        • address30321-00100 Nairobi
        • telephone_number+254 208600406
        • fax_number+254208600010
        • cell_number+254705840706
        • email_addresseva.wainaina@bayer.com
        • created2014-01-21 12:35:01
        • modified2014-03-11 17:10:09
  • 4(array)
    • Application(array)
      • id280
      • user_id155
      • trial_status_id8
      • abstract_of_study<p>\n <strong>ABSTRACT</strong></p>\n<p>\n <em>Schistosoma mansoni</em> infections in the Lake Victoria basin in western Kenya are associated with lake water contact. Previous studies demonstrated an association between school proximity to the lake and the prevalence of schistosomiasis, suggesting that the lake is the primary source of <em>S. mansoni</em> transmission in this area.  In order to determine the best combination of strategies for controlling schistosomiasis, we propose to use this information to help us identify 150 communities with schools that have a prevalence of schistosomiasis ≥ 25% among 9-11 year old students. Prevalence and intensity of <em>S. mansoni </em>infection will be determined by Kato-Katz examination of 3 consecutive stool samples for 100 randomly selected 9-12 year old students, 100 randomly selected Standard one students, and 50 randomly selected adults from the community.  Selected communities will be randomized into 6 study arms.  In the first year, half of the communities will receive community wide treatment (CWT) and half will receive school based treatment (SBT). Over years 2-4, a combination of CWT, SBT or drug holiday will be employed in the various study arms and infection levels in 9-12 year old students will be evaluated. Children in communities or schools scheduled for drug holiday will not be evaluated for infection in holiday years. In year 5, a final evaluation of communities in all study arms will be performed and positive individuals will be treated. The primary outcome will be comparison of <em>S. mansoni</em> infection prevalence and intensity levels among treatment arms. Other samples will be collected as necessary to integrate with SCORE morbidity projects and projects evaluating snails and transmission.</p>\n<p>\n  </p>\n
      • study_title<p>\n <strong>Comparison of School and Community-based Mass Drug </strong></p>\n<p>\n <strong>Administration Delivery Strategies for Control of <em>Schistosoma mansoni </em>Infections in Western Kenyan in Areas with > 25% Prevalence</strong></p>\n<p>\n  </p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/14/03/01
      • version_no1.2
      • date_of_protocol24-07-2010
      • study_drugPraziquntel
      • disease_conditionBilaharzia (Schistosomiasis)
      • 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_namePrazitel
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresspmwinzi@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_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_applicant0721-308588
      • declaration_date103-03-2014
      • declaration_principal_investigatorPrincipal Investigator
      • declaration_date203-03-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n All Persons in study area over 5 years of age.</p>\n
      • principal_exclusion_criteria<p>\n Children under 5 years of age</p>\n
      • primary_end_points<p>\n  </p>\n<p>\n Prevalence of bilharzia in study area</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyDelivery strategy for Mass drug administration
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyCommunity Implementation
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Principal investigators =4  (PhD)</p>\n<p>\n Study coordinators  = 5 (BSc</p>\n<p>\n Laboratory technicians =10 (Diploma in Laboratory technology</p>\n<p>\n Field workers = 6 (Diploma in Community Healt, Public Health)</p>\n<p>\n Temporary staff  =40 (Relevant backgrounds in MSc, Community Health)</p>\n
      • other_details_explanation<p>\n Bilharzia is prevalent in Kenya and information from this study is directly relevant for the national control program</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n National Ethics Committee of KEMRI</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overYes
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorDifferent frequencies of
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaNyanza region
      • single_site_physical_addressKisumu
      • single_site_contact_personDr. Pauline Mwinzi
      • single_site_telephone0721308588
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site75000
      • total_participants_worldwide75000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyMinors, children between 5-18
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namePauline
      • investigator1_middle_nameNgina
      • investigator1_family_nameMwinzi
      • investigator1_qualificationPhD
      • investigator1_professional_addressP.O. Box 1578, Kisumu 40100
      • investigator1_telephone0721308588
      • investigator1_emailpmwinzi@kemricdc.org
      • organisations_transferred_No
      • number_participants75,000
      • notification<p>\n Kindly note that areas left blank are considered N/A</p>\n
      • approval_date30-06-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-03-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2019-03-07 11:21:27
      • created2014-03-03 05:19:57
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id195
        • application_id280
        • given_nameMwinzi
        • middle_nameNgina
        • family_nameMwinzi
        • qualificationPhD
        • professional_addressP.O. Box 1578 Kisumu 40100
        • telephone0721308588
        • emailpmwinzi@kemricdc.org
        • created2014-03-03 05:26:27
        • modified2014-03-03 06:54:35
    • SiteDetail(array)
      • 0(array)
        • id241
        • application_id280
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-03-03 05:26:27
        • modified2014-03-03 06:54:35
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id154
        • application_id280
        • sponsorKenya Medical Research Institute
        • sponsor_type(null)
        • contact_person
        • addressP.O. Box 1578 Kisumu 40100
        • telephone_number254-57-2022929
        • fax_number
        • cell_number0721-308588
        • email_addresspmwinzi@kemricdc.org
        • created2014-03-03 05:26:27
        • modified2014-03-03 06:54:35
• 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
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php