Request History

• Restore to current request
• applications/index/sort:study_title/direction:desc/approved:2/page:4
• applications/index/sort:study_title/direction:desc/approved:2/page:5
• applications/index/page:58/sort:protocol_no/direction:desc/approved:1
• applications/index/page:67/sort:study_title/direction:desc/approved:2

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1746043588
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • sortstudy_title
  • directiondesc
  • approved2
  • page7
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page7
    • current5
    • count501
    • prevPage(true)
    • nextPage(true)
    • pageCount101
    • order(array)
      • Application.study_titledesc
    • limit5
    • options(array)
      • page7
      • order(array)
        • Application.study_titledesc
      • sortstudy_title
      • 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  • 9Application withdrawn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)
      • id153
      • user_id21
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Design</strong>: A 2x2x2 open-label factorial multi-centre trial, conducted in 9 centres in 4 countries (Kenya, Malawi, Uganda, Zimbawe)</p>\n<p>\n <strong>Participants:</strong> 1800 HIV-infected patients including adults, adolescents and children aged 5 years or older with low CD4 counts about to initiate combination antiretroviral therapy (ART). At the Eldoret site, 250 participants will be enrolled.</p>\n<p>\n <strong>Intervention</strong>: Three methods to reduce early mortality following ART initiation</p>\n<p style=\"margin-left: 40px;\">\n (i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral drugs from 3 classes<br />\n (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks<br />\n (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.</p>\n<p>\n Each intervention will be compared with standard of care, which in previously untreated patients presenting late with very low CD4 counts is to initiate ART with 3 drugs from 2 classes, together with cotrimoxazole prophylaxis and macronutrient intervention only for those with low BMI (or low weight-for-height/mid-upper arm<br />\n circumference in children).</p>\n<p>\n <strong>Duration</strong>:
        </p>\n<ul>\n <li>\n Participants will be randomised over 1.5-2 years.</li>\n <li>\n
        Each intervention will be administered in addition to standard of care for 12 weeks.</li>\n <li>\n
        Each participant will be followed for 48 weeks in the trial.</li>\n <li>\n
        The overall trial duration is 3 years.</li>\n</ul>\n
      • study_title<p>\n Reduction of EArly mortaLITY in HIVinfected adults and children starting antiretroviral therapy (REALITY)</p>\n
      • laymans_summary(null)
      • short_titleReduction of EArly mortaLITY in adults and children
      • protocol_noECCT/12/09/02
      • version_no1.01
      • date_of_protocol04-04-2012
      • study_drugRaltegravir
      • disease_conditionHIV
      • 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_nameIsentress
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaksudoi@hotmail.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_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_applicantAllan K Sudoi
      • declaration_date112-06-2013
      • declaration_principal_investigatorAbraham M Siika, MBChB, MMed, Msc - Site Principal Investigator
      • declaration_date212-06-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1. Aged 5 years or older<br />\n 2. Documented HIV infection by HIV ELISA or HIV rapid test<br />\n 3. Naive to ART<br />\n 4. CD4 T-cell count <100 cells/mm3 on blood test taken at screening for REALITY<br />\n 5. Results of screening haematology and biochemistry tests available and no contraindications to planned ART according to national guidelines<br />\n 6. Patient/carer provide informed consent (and children <18 years assent, as appropriate according to their age and knowledge of HIV status)</p>\n<p>\n The lower age limit is because CD4 counts are less reliable predictors of immunodeficiency under 5 years: CD4 counts are recommended by guidelines in older children.<br />\n No patient with a CD4 count above 100 cells/mm3 should have ART delayed in order to subsequently meet eligibility criteria. Rather, patients eligible for REALITY will be those testing HIV positive for the first time with a low CD4 count (i.e. those delaying presentation to care), or those who have defaulted before initiating ART and only return to care at an advanced stage of immuno-deficiency.</p>\n
      • principal_exclusion_criteria<p>\n 1. Contraindications to any proposed antiretroviral drugs (including integrase inhibitors), isoniazid, fluconazole, albendazole or azithromycin<br />\n 2. Pregnant or breastfeeding or intending to become pregnant during the first 12 weeks of the study<br />\n 3.. Ever known to have previously received single-dose nevirapine for prevention of mother-to-child transmission (mother or child).</p>\n
      • primary_end_points<p>\n All-cause mortality over the first 24 weeks after starting ART</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Abraham M. Siika MBChB, MMed, MS- Site Leader/ Principal Investigator</p>\n<p>\n Kara Wools-Kaloustian MD- Co-investigator</p>\n<p>\n Winston M Nyandiko, MBChB,MMed- Co-investigator</p>\n<p>\n Priscilla Cheruiyot, BScN, MPH- Site Coordinator</p>\n<p>\n Charles Kwobah, MBChB- Medical Officer</p>\n<p>\n Mercy Karoney  MBChB- Medical Officer</p>\n<p>\n Simon Wachira Njuguna, B Pharm, MPSK - Pharmacist of Record</p>\n<p>\n Kipruto Kirwa, BSc, MPH, PhD- Quality Manager</p>\n<p>\n Martha Mokaya, BSc, MBA- Data Manager</p>\n<p>\n Wilson Lokitala Ekiru, BSc IT- Assistant Data Manager</p>\n<p>\n Agnes M. Nzioka, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Betty Meli, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Michael Tanui, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Julie Choge -  Recruitment Officer</p>\n<p>\n Amina Msuo Shali - Recruitment Officer</p>\n<p>\n Dorothy Mwimali -  Recruitment Officer</p>\n<p>\n Cecilia Chebet, Dip Counselling - Recruitment Officer</p>\n<p>\n Beatrice Jakait, B Pharm- Back-up Pharmacist</p>\n<p>\n Chris Sande, KHRCN- Study Nurse</p>\n
      • other_details_explanation<p>\n Whilst WHO guidelines now advocate earlier initiation of ART in HIV-infected adults and children 5 years or older at <350 rather than <200 cells/mm3, in clinical practice, substantial numbers continue to present for care late in HIV infection - in both resource-rich and resource-limited settings. Given experience in resource-rich countries, this will continue to be a feature of ART rollout programmes for the forseeable future. However, the consequences of such late presentation, in terms of early morbidity/mortality on ART, are far more severe in resource-limited settings. To maximise benefits of ART, it is essential to identify which interventions, if any, in addition to ART could reduce high early death rates. Data from both adults and older children demonstrate the highest early mortality in those initiating ART with CD4 cell counts <50 cells/mm3 (see Section 1.1 of the protocol): early mortality rates approximately halve in those with CD4 cell counts 50-99 cells/mm3 and halve again with pre-ART CD4 cell counts >100 cells/mm3. Thus those with CD4 <100 cells/mm3 have substantial risks, and present in sufficient numbers, that interventions of proven benefit in this group could rapidly improve ART outcomes.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Moi Teaching and Referral Hospital/Moi University Institutional Research and Ethics Committee (IREC). Approval granted on 20 June 2012.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationPArticipants will be randomized over 1.5 to 2 years. The overall study will take three years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStandard 2 NRTI+NNRTI plu
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyIsoniazid, Fluconazole, Azithromycin,Albendazole
      • 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_states4
      • number_of_sites2
      • multi_country_listZimbabwe, Uganda, Malawi, Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site250 at Eldoret Site
      • total_participants_worldwide1800
      • 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_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameAnthony
      • investigator1_middle_name
      • investigator1_family_nameEtyang
      • investigator1_qualificationMBChB
      • investigator1_professional_addressKEMRI Wellcome Trust Research Programme PO BOX 230 Kilifi, 80108 Kenya.
      • investigator1_telephone+ 254 41 752 2063
      • investigator1_emailAetyang@kilifi.kemri-wellcome.org
      • organisations_transferred_No
      • number_participants250 at Eldoret Site (200 adults and 50 Children)
      • notification
      • approval_date04-04-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-06-2013
      • 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)
      • modified2018-03-26 12:24:16
      • created2013-06-11 12:27:30
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id97
        • application_id153
        • given_nameAbraham
        • middle_nameMosigisi
        • family_nameSiika
        • qualificationMBChB, MMed, MSc
        • professional_addressP O Box, 4606-30100, Eldoret
        • telephone0721280785
        • emailamsiika@africaonline.co.ke
        • created2013-06-11 12:37:44
        • modified2013-06-12 16:38:34
    • SiteDetail(array)
      • 0(array)
        • id123
        • application_id153
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressAMPATH at MTRH, Nandi Road, Eldoret
        • contact_detailsP O Box 4606-30100, Eldoret
        • contact_personAllan Sudoi
        • site_capacity(null)
        • misc(null)
        • created2013-06-11 12:37:44
        • modified2013-06-12 16:38:34
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 1(array)
        • id124
        • application_id153
        • county_id3
        • site_nameKEMRI Wellcome Trust Research Programme
        • physical_addressKilifi
        • contact_detailsPO BOX 230 Kilifi, 80108 Kenya
        • contact_personDr Anthony Etyang
        • site_capacity(null)
        • misc(null)
        • created2013-06-11 13:02:53
        • modified2013-06-12 16:38:34
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
    • Sponsor(array)
      • 0(array)
        • id78
        • application_id153
        • sponsorMedical Research Council, UK
        • sponsor_type(null)
        • contact_personDirector, Regional Centre London
        • addressAviation House, 125 Kingsway, London
        • telephone_number+44 (0) 20 7670 4700
        • fax_number+44 (0) 20 7670 4816
        • cell_number+44 (0) 20 7670 4700
        • email_addressREALITY@ctu.mrc.ac.uk
        • created2013-06-11 12:37:44
        • modified2013-06-12 16:38:34
  • 1(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
  • 2(array)
    • Application(array)
      • id745
      • user_id691
      • trial_status_id8
      • abstract_of_study<p>\n Malnutrition is a major public health problem worldwide. More than 250 million children less 121 than 5 years of age are underweight, stunted or wasted. Malnourished children need diets that 122 provide necessary nutrients, for growth and development. Currently Corn-Soy flour Blend 123 (CSB) fortified blended flour commonly used in treating moderate acute malnutrition (MAM) 124 favour large intake of omega 6 and negligible omega 3 fatty acids. Long chain Omega 3 fatty 125 acids are anti-inflammatory and effective in treating some inflammatory disorders. This MAMI RCT VERSION 1.1 NOV 2016 Page 6 126 proposal seeks to study how adding fish oil to CSB affects the systemic inflammation and 127 other clinical outcomes of the malnourished children child. We propose to carry out the work 128 in Kibera slum in Nairobi County. The project has potential to provide valuable information 129 that can change policy on management of acute moderate malnutrition</p>\n
      • study_title<p>\n Randomized Controlled Trial to Compare the Effect of Corn-Soy Blend + Vegetable Oil 8 and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO) on 9 the Immunological and Microbiota Patterns among Children Aged 6 to 24 months with 10 Mod</p>\n
      • laymans_summary(null)
      • short_titleRandomized Controlled Trial to Compare the Effect of Corn-Soy Blend + Vegetable Oil 8 and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO) on 9 the Immunological and Microbiota Patterns among Children Aged 6 to 24 months with 10 Mod
      • protocol_noECCT/18/12/02
      • version_no1.1
      • date_of_protocol01-11-2016
      • study_drugCorn-Soy Blend + Vegetable Oil 8 and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO)
      • disease_conditionMALNUTRITION
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameCorn-Soy Blend + Vegetable Oil 8 and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO)
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressezekiel.muinde@yahoo.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_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_applicantEZEKIEL MUINDE
      • declaration_date114-12-2018
      • declaration_principal_investigatorDR PHELGONA A. OTIENO
      • declaration_date214-12-2018
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Inclusion criteria:</p>\n<p>\n 382 ï‚· Resident and living within Kibera Slums in Nairobi for the duration of the study 383 ï‚· Aged 6 - 24 months with MAM, defined as weight-for-length z-score (WLZ) between 384 -3 to -2 and/or mid-upper arm circumference (MUAC) of 11.5 to < 12.5cm. 385 ï‚· Caregiver is able and willing to provide informed consent.</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria:</p>\n<p>\n 388 ï‚· Severe acute malnutrition (SAM) WLZ< -3 and/or MUAC < 11.5 cm 389 ï‚· Chronic malnutrition: Length-for-age z-score (LAZ)<-2 390 ï‚· Severe anemia Hb < 6 gm/dl 391 ï‚· Other chronic illnesses such as AIDS, TB or malignancy 392 o HIV test positive by Determine and Unigold rapid test kits. If the child is <12 393 months PCR testing will be conducted to determine HIV status. 394 o History of TB or malignancy 395 ï‚· Active infections in the past two weeks such as: Pneumonia, Gastroenteritis, Urinary 396 tract infections or Meningitis ï‚· Temperature >37.50 397 C 398 ï‚· Gross Congenital abnormalities</p>\n
      • primary_end_points<p>\n a) To determine the effect of Corn-Soy Blend plus fish oil (CSB-VO-FO) compared to 718 standard-of-care [Corn-Soy Blend plus vegetable oil (CSB-VO)] on level of expression of 719 inflammatory markers in children with MA.</p>\n<p>\n b) To determine recovery and growth rates among moderately malnourished children 729 receiving either CSB-VO-FO or CSB-VO as supplementary food. 730 MAM recovery rate: The percent of children who attain normal nutrition status within a 731 period of 12 weeks will be compared between the two intervention arms.</p>\n<p>\n c) To determine the effect of Corn-Soy Blend, vegetable oil plus fish oil (CSB-VO-FO) 736 compared to standard-of-care [Corn-Soy Blend plus vegetable oil (CSB-VO)] in the 737 composition of the fecal microbiota.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence1
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Beatrice Olack: Is a Co-Principal Investigator who has been involved in proposal 840 development. She is the contact person for the project and will be involved in study 841 Coordination. She will continue in application for grants and be involved in nutritional 842 aspects of the study including development of SOPS, nutrition counseling and nutrition 843 therapy. She will also be responsible for training of research assistants on anthropometry and 844 nutrition counseling. She will also be involved in manuscript writing </p>\n<p>\n Dr. Margaret Mbuchi: Is a co-Investigator who has been actively involved in the protocol 846 development especially on the laboratory methods of the study. She will be responsible in 847 overseeing all the laboratory activities of the study including leukocyte stimulation with 848 various pathogens and preparation for RNA extraction for further tests. She will organize the 849 exportation of specimens to UTMB as required. Dr. Mbuchi will also be involved in 850 manuscript writing.</p>\n<p>\n 851 Dr. Mary I. Matilu: Dr. Matilu has contributed to protocol development. She will be 852 involved in developing SOPS and other study tools. She is core for clinical activities of the 853 study. She will also participate in training study staff on clinical aspects of the study. She will 854 also be involved in implementations of the study by overseeing the clinical activities for the 855 study. Dr. Mary will also be involved in manuscript writing</p>\n<p>\n 856 Rukia Kibaya: Is a co-Investigator who has been actively involved in the protocol 857 development especially on the laboratory methods of the study. She will be involved in 858 specimen handling to ensure quality at all levels as well as conduct of various tests required 859 for the project. Rukia will also be involved in manuscript writing</p>\n<p>\n Dennis Kivuva: Is a Co-Investigator who has been actively involved in protocol 861 development. He will be involved in data collection as well as nutritional components of the 862 study such as developing SOPs and anthropometric measurements.</p>\n<p>\n 863 Christine McGrath: Is a Co-Investigator who has been actively involved in proposal 864 development. She will be involved in advice on various approaches for data analysis and 865 manuscript writing. 866</p>\n<p>\n Thaddaeus Egondi: He is the Biostatistician for the project. He will be involved in 867 developing the statistical plan for the study as well as develop database and running data 868 analysis for the study in conjunction with the rest of the team. 869</p>\n<p>\n Bernhard Ogutu: Is a Co-Investigator who has been actively involved in proposal 870 development. He will be involved in advice on various approaches for study implementation 871 and analysis as well as manuscript writing.</p>\n<p>\n 872 Linet Ouma: Is a Co-Investigator who has been actively involved in proposal development. 873 She will be the involved in data collection SOP development, coordination of field activities 874 and manuscript writing.</p>\n
      • other_details_explanation
      • other_details_regulatory_notapproved<p>\n none</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration20 weeks
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overYes
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparator Corn-Soy Blend + Vegetab
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKENYA MEDICAL RESEARCH INSTITUTE
      • single_site_physical_addressCENTER FOR CLINICAL RESEARCH- CCR
      • single_site_contact_personDR PHELGONA A. OTIENO
      • single_site_telephone0721973971
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_sitesample size of 40 subjects per group will have 80% power to detect a 20% reduction
      • total_participants_worldwide40
      • 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_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_specifyTHE PARTICIPANTS ARE CHILDREN UP TO 24 MONTHS
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namePHELGONA
      • investigator1_middle_nameAPONDI
      • investigator1_family_nameOLANDO
      • investigator1_qualificationMBCHb
      • investigator1_professional_addressKEMRI
      • investigator1_telephone0721973971
      • investigator1_emailphelgona@gmail.com
      • organisations_transferred_No
      • number_participants40
      • notification
      • approval_date25-02-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-12-2018
      • 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)
      • modified2023-03-31 09:43:24
      • created2018-12-10 11:31:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id465
        • application_id745
        • given_nameCHRISTOPHER L. MELBY
        • middle_name
        • family_nameMELBY
        • qualificationdoctor of public health
        • professional_addressDepartment of Food Science and Human Nutrition Nutrition and Metabolic Fitness Laboratory 226 Gifford Building Colorado State University Fort Collins, Colorado 80523
        • telephonePhone: Office- (970)-491-6736; Lab-(970)-491-3373
        • emailchris.melby@colostate.edu
        • created2018-12-17 08:19:47
        • modified2018-12-17 10:08:02
    • SiteDetail(array)
      • 0(array)
        • id587
        • application_id745
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-12-17 08:19:47
        • modified2018-12-17 10:08:02
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id362
        • application_id745
        • sponsorKENYA MEDICAL RESEARCH CENTER
        • sponsor_type(null)
        • contact_personDR PHELGONA A. OTIENO
        • addressP.O. Box 54840 00200 Off Mbagathi Road, Nairobi, Kenya.
        • telephone_numberTel:+254 020 2713349 / +254 020 2722541 / 0722-205901
        • fax_number
        • cell_numberTel:+254 020 2713349 / +254 020 2722541 / 0722-205901
        • email_addressINFO@KEMRI.ORG
        • created2018-12-17 08:19:47
        • modified2018-12-17 10:08:02
  • 3(array)
    • Application(array)
      • id870
      • user_id336
      • trial_status_id1
      • abstract_of_study<p>\n <strong><em>Background:</em></strong><em> Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. The WHO led the development of a PPH first response treatment bundle based on existing recommendations and the effectiveness of the bundle will be the subject of the E-MOTIVE implementation research. The key pharmaceutical components of the bundle are oxytocin and TXA. Several studies looked at the quality of oxytocin at the point of sale and found that in many places the active pharmaceutical ingredient was below the specifications. There are currently no quality assessment studies of TXA.</em></p>\n<p>\n <strong><em>Objective:</em></strong><em> To evaluate the quality of oxytocin and TXA products at the study facilities in six countries.</em></p>\n<p>\n <strong><em>Methods:</em></strong><em> Laboratory based analytical study in which samples of oxytocin and TXA will be collected from participating sites and analyzed in a central research laboratory. Before sample collection, all manufacturers and products used in the study facilities will be mapped according to their registration status within the country and label instructions. We will not test the products in countries where there is one government approved procured product and those products that are SRA approved or WHO prequalified product. The ampoules will be shipped to the testing laboratory by a courier service and transported in such a way as to avoid damage during transportation. Oxytocin samples will be transported at 2-8°C and freezing will be avoided. Both oxytocin and TXA samples will be tested at Monash Institute of Pharmaceutical Sciences at Monash University, Australia. The laboratory will start testing only when all the samples are received. Testing methods and specifications will follow the International Pharmacopeia for oxytocin and the British Pharmacopeia for TXA. Samples will be tested for appearance, identity, assay, related substances, and PH as per International Pharmacopeia specifications. Laboratory procedures will be blinded, and packaging and labelling assessment will not be conducted by the same person who carries out the chemical tests.</em></p>\n<p>\n <strong><em>Analysis:</em></strong><em> Results of the visual inspection and chemical results will be entered in the Analytical test report form. The International Pharmacopeia will be the reference for the evaluation of the oxytocin results and the British Pharmacopeia for TXA. This will allow comparison of samples from different manufacturers. This specification will be used to decide on compliance or non-compliance of the tested samples for the purpose of this study. Non-compliance with the specifications selected for this study will not imply non-compliance with the specifications approved in the country, but it will indicate the need to look at the product more closely.</em></p>\n
      • study_title<p>\n Quality of Oxytocin and Tranexamic acid in selected facilities in six countries</p>\n
      • laymans_summary<p>\n <strong><em>Background:</em></strong><em> Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. The key pharmaceutical components of the PPH managment  are oxytocin and TXA.  Quality of oxytocin at the point of sale  has been found to be below the specifications. There are currently no quality assessment studies of TXA.</em></p>\n<p>\n <strong><em>Objective:</em></strong><em> To evaluate the quality of oxytocin and TXA products at the study facilities in six countries.</em></p>\n<p>\n <strong><em>Methods:</em></strong><em> Laboratory based analytical study in which samples of oxytocin and TXA will be collected from participating sites and analyzed in a central research laboratory. Samples will be tested for appearance, identity, assay, related substances, and PH as per International Pharmacopeia specifications. Laboratory procedures will be blinded, and packaging and labelling assessment will not be conducted by the same person who carries out the chemical tests.</em></p>\n<p>\n <strong><em>Analysis:</em></strong><em> Results of the visual inspection and chemical results will be entered in the Analytical test report form. The International Pharmacopeia will be the reference for the evaluation of the oxytocin results and the British Pharmacopeia for TXA. This will allow comparison of samples from different manufacturers. This specification will be used to decide on compliance or non-compliance of the tested samples for the purpose of this study. Non-compliance with the specifications selected for this study will not imply non-compliance with the specifications approved in the country, but it will indicate the need to look at the product more closely.</em></p>\n
      • short_titleQuality of Oxytocin and TXA
      • protocol_noECCT/20/06/07
      • version_no1
      • date_of_protocol13-12-2019
      • study_drugNone specified as these are routine drugs
      • disease_conditionPPH
      • 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_nameOxytocin and Tranexamic
      • 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_letter1
      • 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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicant0733650140/0721310750, zahida@qureshi.co.ke
      • declaration_date124-06-2020
      • declaration_principal_investigatorProf. Zahida Qureshi
      • declaration_date224-06-2020
      • placebo_presentNo
      • study_objectives<p>\n To evaluate the quality of oxytocin and TXA products at the study facilities in six countries.</p>\n
      • principal_inclusion_criteria<p>\n <span style=\"font-size:11px;\"><span style=\"font-family: Helvetica;\">Health faciliities: are eligible for inclusion if they are able to provide comprehensive obstetric and newborn care for 750 to </span></span><span style=\"font-size: 11px; font-family: Helvetica;\">5000 births a year and are part of the E-MOTIVE study.</span><span style=\"font-family: Helvetica; font-size: 11px;\">.</span></p>\n
      • principal_exclusion_criteria<p>\n None, all 16 study facilities are eligible </p>\n
      • primary_end_points<p>\n Quality of Oxytocin and Tranexamic acid inluding appearance, identity, assay, related substances, and PH as per International Pharmacopeia specifications</p>\n<p>\n  </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_specifyPharmacovigilance
      • 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 staff who will coordinate the drug sample collection will be those involved in the EMOTIVE formative phase and trial.  This is not a clinical trial, additional comptencies are not necessary.</p>\n
      • other_details_explanation<p>\n Because the primary study  E-MOTIVe is being conducted in this setting where there is the highest burden of PPH. The burden of PPH is low in the UK or USA.</p>\n
      • other_details_regulatory_notapproved<p>\n <span style=\"font-size:11px;\"><span style=\"font-family: Helvetica;\">Kenyatta National Hospital-University of Nairobi Ethical Review Committee</span></span></p>\n
      • other_details_regulatory_approved<p>\n NA</p>\n
      • other_details_regulatory_rejected<p>\n NA</p>\n
      • other_details_regulatory_halted<p>\n NA</p>\n
      • estimated_duration March 2020 – August 2020.
      • 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_states6
      • number_of_sites16
      • multi_country_listKenya, Tanzania, Nigeria, South Africa, Sri Lanka and India
      • data_monitoring_committeeYes
      • total_enrolment_per_siteNA
      • total_participants_worldwideNA
      • 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_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameZahida
      • investigator1_middle_name
      • investigator1_family_nameQureshi
      • investigator1_qualificationMBBS MMed (Ob/Gyn) Professor of Obstetrics and Gynaecology
      • investigator1_professional_addressUniversity of Nairobi
      • investigator1_telephone0733605140
      • investigator1_emailzahida@qureshi.co.ke
      • organisations_transferred_No
      • number_participantsNone
      • notification<p>\n We do not think this protcol meets the threshold for a clinical trial but drug testing as aprt of a planned E-MOTIVE intervention. These are standard drugs used in these facilities for the management of patients with postpartum bleeding.  We are at risk of being excluded as a country if we delay with our approval. We are open to clarfiying some question on phone or in person if tjis can shorten the review process.  We are kindly requesting for quick review and advice</p>\n
      • approval_date19-10-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-07-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy approved by the expert committee
      • final_report<p align=\"center\">\n <strong>CONCEPT STUDY FINAL PROGRESS REPORT</strong></p>\n<p align=\"center\">\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:241px;height:94px;\">\n <p>\n <strong>Full title of trial</strong></p>\n </td>\n <td style=\"width:349px;height:94px;\">\n <p>\n Quality Of Oxytocin And Tranexamic Acid In Selected Facilities In Six Countries. (P229/04/2020)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n <strong>Short title</strong></p>\n </td>\n <td style=\"width:349px;\">\n <p>\n EMOTIVE Concept  Foundation Study</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n <strong>Sponsor</strong></p>\n </td>\n <td style=\"width:349px;\">\n <p>\n University Of Birmingham</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n <strong>Sponsor number </strong></p>\n </td>\n <td style=\"width:349px;\">\n <p>\n RG_19-263</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n <strong>PPB Reference</strong></p>\n </td>\n <td style=\"width:349px;\">\n <p>\n PPB/ECCT/20/06/07/2020 (121)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n <strong>Chief Investigator</strong></p>\n </td>\n <td style=\"width:349px;\">\n <p>\n Prof. Arri Coomarasamy</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n <strong>Concept  Activities</strong></p>\n </td>\n <td style=\"width:349px;\">\n <p>\n Collection of  Oxytocin and Tranexamic samples from study sites</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n <strong>Date of this progress report</strong></p>\n </td>\n <td style=\"width:349px;\">\n <p>\n 01^st August, 2023</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n <strong>Investigators and addresses  </strong></p>\n<p style=\"margin-left:144.0pt;\">\n <strong>Chief Investigator:</strong>              Prof. Arri Coomarasamy, Institute of Metabolism and Systems Research, University of Birmingham, Edgbaston, B15 2TT</p>\n<p style=\"margin-left:108.0pt;\">\n               Email:<u>A.Coomarasamy@bham.ac.uk</u>   </p>\n<p>\n <strong>University of Nairobi Team:</strong></p>\n<p>\n <strong>Principal Investigator:        Prof. Zahida Quresh</strong></p>\n<p>\n <strong>                                              </strong>University of Nairobi, Faculty of Health Sciences, School of Medicine, Department of Obstetrics and Gynaecology.</p>\n<p style=\"margin-left:144.0pt;\">\n  </p>\n<p>\n <strong>Co-Principal Investigators</strong>: Dr. Alfred Osoti and Dr. George Gwako</p>\n<p>\n  </p>\n<p>\n <strong>Concept Activities Conducted</strong></p>\n<p>\n The Pharmacy and Poisons Board (PPB) approval was granted on 19^th October 2020. Thereafter study activities commenced in December 2020 with Tranexamic acid and Oxytocin samples were obtained from Kerugoya County Referral Hospital, Busia County Referral Hospital, Ruiru Sub County Hospital, Iten County Referral Hospital, Kakamega County General Hospital, Maragua Sub County Hospital and Embu Level 5 Hospital. The samples were shipped to Monash University in Australia for analysis in March 2021.</p>\n<p>\n The analysis report was obtained and shared with the study sites, County Pharmacists and the Pharmacy and Poisons Board. The Concept study publication was also shared with the hospitals, Pharmacy and Poisons Board and the stakeholders from the Division of Reproductive Health (MOH). A stakeholder’s engagement meeting that was held virtually on 5^th May 2023 among the Kenya hub team and the MOH officials. Plans are under way to send the second batch of Tranexamic acid samples (which were not previously tested) to the Concept Foundation to establish if this can be administered alongside Oxytocin during the management of PPH.</p>\n<p>\n During the study close out period there were discussions with the facilities leadership, healthcare providers and County Health Management Team to ensure that there is availability of essential drugs and also use of quality drugs.</p>\n<p>\n  </p>\n<p>\n <strong>Report Completed by:   Name </strong>Jenipher Okore                       </p>\n<p>\n <strong>                                         Role: </strong>Study Coordinator</p>\n<p>\n <strong>                                         Signature:      </strong><img alt=\"\" src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAGcAAAAvCAYAAAGJTeRuAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAAFxEAABcRAcom8z8AAA+mSURBVGhD7Vv5dxRVFp7/zjO/O78wMy4jW9gGkCWbYV9EiQo4w+IAsoiDBBGSkLDIiASRzRjAHBUSIJClE5LudHd1VXV1f/Pd9/qlqyvVoZsEDQf78FHd9Zb77vrufVX5UyaTQbkoe1A2mzWDXKysrsTAkyewbVs1ep6Ha1dv8DvGBhioQWnXfzONLDycbjyFQzv+BXtoBFfa2tA/HA8OyrJjGo7jIOMB6TSvY5Noqua7b3mFDRp6WTduyBLz7XItWxCCZx3kIe3ZSHpZpFKpsQZZhusElzw2KIMVy6vVjywnyGRduG4clcsqMXi3C1Z0BCtr6sIGVVF6GaxdvUVJx98hKKAC6cnHfL929Yex7wL/wAmlF6Q4EaRvEME+4wilbYfyYMd0uOAMZDJlQCFtYdCEKGQx2eMNjfwu4khykjT6+/sLxFMIuW+g71mWhQcPHkzMkUdzaLv0fUEj4AoZvDVzHqyUDDaTpoFUHh7vZ3Ntyjpy4/3IEaIn0X9sy0N15Xrs3vkpIgNPuDIRkelMt6RSP/7446Iik/ag9RgUNYYwaJFwIop6oknDUBahZwUX1B1KqJiJFoPp74e/vSihqYQQHU9I5O7Q0mhGtpUPSEG4rluWD+UIiULFRB2k7FEcoS/FSWvT5rVmNcFBRAaPH/fxd6EfFYMmlNUrc2wP27bv4U0HaSeONB03neZeE5C3hvGpPCHhUPqeOXNG/fYjLzo667WrN9W1sJOYMrmlOWe9BH7pvIVN6zagZtFS3Gm7gkRkCE40jmgkgpraOgzGEoHxGnlCXNXGDe/qGOfrkEnb6Op6gMbG89xE0gxTWoxZhqdgZFD3/WN9yIuOO+u5s/8j6+zMbVlEEItRX4e/hMe55BM2gYHoLey+zJMTPQmRiAqqjNbvbtqGluZvsGb1Rm570lmI6kGiL5H/yMhI6MRyrxhBzVHgZrjyM/j8SAMjZyFnsVhsrH8YIXMvlFAxyDaifUd0QhRZfRjKIvQioGyGjBEVU+Nk4J97IoSNNXjhNRTC7MQMZRlYPMaaAYbpw/s+xaG9+3H7ZjtDbXj/UnDw4EGVWsXj+QpgquDTUDoHdVOFGvleW7MOj/uewGFdk3SjSDhR8pJBR0c3bt68qZzX9C0FsodJSidXyRl5y4fwMeUgz1CWxRdjquxl8VEL8ZiDhfNX4NadTqRcC3YiBdiM3lI6cQdPZRKKcVGz7OilMyVm4WfCj3w/mffAgQN47bXX0NfXh2QyqcocoenvF4RPQwaUHnfvnTs/oWl8riRZ2J4H2YDD/72s1ihzZthxG03HG1GxYCmOHj+Jh70DsDmfywXaXEyMm80w0UNz6+zrxdc3b6D16hWcu3Edt3+4i57uAcSjltoZHW5YYg3uM4XtbC6nEg04wPZtu9Dc3KIydq5XX5UUWaO4skdILsyNKDqKqspanD93kfu9aI9KFN58REpFwLlLgn+MIERDAimsPFTMXYTOzk4kEsO8R10wQRHzajh2Au9u3gorwYVLHqF2Wy5CTFaZLk3U1n2FiNRKEgDK8bfgQsP6hEExNJFdyqLMVSaWvgbBvgWgVuu37lDphcp5BNSwDgr5OUZHR7Fr165x85XKUEi/MA1NHuKHkuvmFypXncb4ERw3WXBOxdDq6Q6a6hjC2g3I0OLnoqHfCy8nMyGON6UIzh+GsHF+vJzMTEcEGX2JmGHeZCct7n6y7RPcAOXI1s09MSgXkhHIPmOeOEw1JmQmK2csTOXb/ncROz74CK2NzYgODT9zzSOnG83NzWWVFeWAzMiOrHdqDcm5JKVx8PWFVqyorsKDviHEmZfZ1M6xL4/j3PmWMSmHTeqH9Mkji5bT5shMpzsaUxNQyIxhQktLiFpWCleufI8tW3YyNc8gbsWY3ltI2Elm0kBd3bsqd5NPKQwZ2LbO97SNPw9mVPYrmtDMOCTo2FksXLAMXQ8GyIwQslkWJLl0LsjJYHB4VC1IPsb5SoOfAT8K55BPIpFQGbgkpVK4ifCeZp76+FCdvorZsBywPZw/24aaqg2wWG1mWeS4lgMvQQ3IE0AWay5LUknxhYDJsktDGCOCQmakhJgxYwaLR1oG5xdaYgH6DM4/XyEKAwCZSSZsrF61Hh0//lTQMQj92EWbZ1ZOgMXXyKjnRln0xTAajeD695exd88nqGVRt2zxcny4ei2+bjiB++0diD14BGtoBE4sDnskimR0mBVoFz7/7HPMnlOBhpNN+mFQCO1iCEQzYKB/CPPn/RN2qrhKPTJiU5t0aWqVUpWy283iXuddVNasQXXdWvzQcYe+Ru1R6g6larMsjXJxgyxRfx7ox+XOOzh7/SqaLl/ClR/voOvnx+h/PMTtQAQF5auuEth4+sUwjpl7d+8rZp5WEoPaEO2Iz+zffwhLl1ajrz/G8BsfK85cdUIj/bUG/UfofmTph1w7+xT6YLGHbsVAn5ENjMRyC3jU04ulS5YpW1VnAgIhRBPU4VgckSUx96AzrefxTu0aDA2O0rwo9sABdjkQJgzC2sMQHKOjmZKcZsZKprFk8TL09vZxbfKYX6BPZsQBZeC3F9tQuXI1Iv30D3nCn5No/ilk+cjvRaVrYzwzgQ6plIMjnx3DqroN3FMSVH+K+0NSRZjIwBCWL6vCd23XGfW0JvRJDseqEJ/iTahQahYm4VV+yzVIqxiCiywV+oGLWpA4c+4RK2v579raMXvmYhw5fIIR5gSqq9bgqxNNSnsSwiVk62fCfoJ67xENRiIRbN++HZcuXVJt5YRwIwhBWHsxjNOMHyaum9SlFCI2ldPzsA+v/X0moiMJ7YtKWDpbMBBNSZ7W3d1d8MKGoFTNBPtNyIxACD9tUj8ePujDnt37kYgzsChGio+9ffv22Ibov+9n2n8/iGC/pzJTLiTKiZmKKep7QkiH5iDxqYQIfMqZUZogI1KzaI2SERUctAaeFzMypzATeg41XUB/LencTPAcNPMHpgK0tOdz7PwHJo/nphwTt8IQ1n86IWzNz4qw+UsFx//hOdMVfyjnd4Tfw4LItU9OOfIGS7kIm+dlRFAhfuTan105aYe5sc1yLs0KiEKXAxc5eoe84i2vN8ohUu673PfYN5VIhs71PCBMSvVkSk5T3EvpGew7HRGiHNGaH1Jl6fNcN51i0UJBqyNNuZcio3F03e/CseMNqKpdj+WV67B7bwMufncLFy934ODhBtR/sA0fbfsQ7e1XKKgYx+naXK5SBJkDA2Mx5ULmKAZ5b6amphavvPJn1Nd/iF9+uUvaQkeKr2IIp/Nbw6ccXe6GIZ07DGSVzwHqVBijo1E0NjZj4YKlqP9wB365dx8WvcOmQBIUcozVp5xQWW4aSfEufm9uOoOt73+E3t5eJTihKx9RjnzMvXLhV4Yf8vqLOiLjdzlWs5K2uuojs2KYjsqhN+gSPgelGN3JpdDF2uRPeYSx3scR1L2zFitXrsGFCzeRsjNIOWQKHIMUXC9KmSRguyNq3hTDn0emR0Y8HD3ajNbWVvWekHiKfDQN/XzK0JwayHxB4T8Nxddg1mq8Xq4SMuUqb3nev39f8SVtcsJWyjuCE8GnHFEKLbxAObJQWqC8/0cFyIlzZCCGTRs/wLy5b+P06fNIpV0K36Z3cY9R+04WaYs+Q4VmbCqFniOv4XsUvEPNOgyVsmhhyCxclOL/PXWYWuUYZXR0dKClpQUnT57E1q1bsWjRIuzZs0dFBGk3njtZg8srJwxyyifCdqUjaBUWtm/7N95euhL79x1GfLT45m4WGAZJFCRpUFBKFQWK51JBNAx5ZVSeRLrq1VGb/zNERqlwroXaRTZFpmkAmRTpuxac+BO41iC81CCTjwgTj37+foR4MkIboSdnLFhenPPQmr0EjcRCnHtfLDXMaxQW9015+9bOSsKQoGHFFNLWE84Xp4EluXc9QZLecK+7Gx/v/ARvV9bivyeaMBSX9YlSw+XwrBA5FSgnKET+UxBrGn4SwxdHv1RP3TZtfB+jsZRWnm9CP8QLisGlEgRppQwNST48Kkkgf7CiCRPsn6X3jYz24m73LXzVeBTvbd2Ahf+ci1mzZ2LZihVYu24jtm3bhS++OIVvvrmCby9ew9kzbTh44AiNaQeqqqoxe/Yc/HXG3/Dqq3/B66+/gTmzOX7WbFTMnafw1luzUFExH0sWvY0FsxZhzpvziAq8PuMfmPnmXKx6Zx295Rx+/rkLSRqHyzUmuJcmmYlKcB4vO40w2ZSCnKwm8Jycq8s5ec/DXry3pR4L5i9GU2Oregr/LMTl+a/DLI8qUntUWhIOeZjNNpnPJuN9jwZwruUCVteux8KKJdiysR4nTn6LX+9GEE+4GI179Ap5NkxHEgdkuBRP0x6XzIEWLwwy1wiDcdwglCMH++bApXOdAj9PEoqnOhxrlKycLmZjmza+R4ubj+vX2hUT4/6kqySIFJiSMxxlXV75u7enB8eOHqOF16Ju1Toc/6oFDx8NMtOTbA8MRbwyXMWTfXDcYSoxScjDR0k0xOtyghNwXQYpKi1BMwiHtI2HJa96cF4xGIH6UydFQ3u3QD2Lz0Hvs2F8Th555ahkIPe8XTXmGRarGRkexb69h7BkyTLs3vWJykZEacrSxqCTB497imyGsoH6YSysr3cIjadaUV21CiuW1+DUydMYGhxRc0g2KBCaNHz+0HObBf8W8IclP8L6Tga50BWKXLvxHGMd/glEKIDNECaZ2uNH/SqFfvONWYzrlxlimA5nuIlyw9VguMrYhM5Y5EmbEJK3Otp/6ED91o9UMnHqq/MY6BtmyJD3esQCRRmiUNlzZHFULAtfN23xSg9jQlC4rucLI6AgwvpOBmE0DHLtRjlaEf7BRmGySUudI0Vd170e7Nn9KSrmLMYH9TtY9XeoV9okxKUsyet1XZSIJ9HU1ILq6jqsX7cZX5+/yCSCgiYNXRhqD1HeOUbbWGfOUExaTwRfAzUMiEeadywkRTcwhuEf86JBKUe7rB/SKIzllEPosGTSah26YlELd399iHNnv8WRzxpw+NBRHPviBENWC251/MR2eV1PahgpYk16yLnV+yAaQkeEqDO1MGHqNYnnuixmZZ4ff7yNzZveZwZWgX37DiASGVL3pZ8j533SXxmT0CgeooQnUaoUkHJP3lc0bb8F/Ovxw7T7lDN+cCnwTyjMmr3G3A9DcI6SQA+T8HjjWgfWrd2Mvf85iMHIiMoax3ufphFG20Da29vbmYRUYd68ebhw4cLYmDGavzOUcsIaphukzur86Vd0d/WoMCqh0XhLWH+VVTFuBpViED5m+kDW+MIoh2tVHyl8JazqfSt/oj0Whn371IusHAnJL4xyXkZ4ntf9fw6OXMtfmnn5AAAAAElFTkSuQmCC\" />                                      </p>\n<p>\n <strong>                                         Date: </strong>01^stAugust, 2023</p>\n<p>\n  </p>\n<p>\n <strong>Reported Verified by:    Name:</strong> Professor Zahida Qureshi</p>\n<p>\n                                         <strong> Role</strong>: Principal Investigator</p>\n<p>\n                                         <strong> Signature</strong>: <img alt=\"\" src=\"data:image/png;base64,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\" /></p>\n<p>\n                                          <strong>Date</strong>: 01^st August, 2023</p>\n
      • implication_results<p>\n The Oxytocin and Tranexamic analysis report was shared with the Pharmacy and Poisons board, County Pharmacists and facilities. The hub leadership is currently engaging with the MOH and discussing on the future plans on the adoption of the findings in the report. The aim is to have standard products used in the management of Postpartum Haemorrhage.</p>\n
      • quantity_importedNot Applicable,
      • quantity_dispensedNot Applicable
      • quantity_destroyedNot Applicable
      • quantity_exportedOxytocin 200 vials and Tranexamic acid 380 vials
      • balance_siteNot Applicable
      • final_date0000-00-00
      • modified2023-08-02 10:36:06
      • created2020-04-13 06:33:38
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id534
        • application_id870
        • given_nameZahida
        • middle_name
        • family_nameQureshi
        • qualificationMBBS MMed (Ob/Gyn) Professor of Obstetrics and Gynaecology
        • professional_addressUniversity of Nairobi
        • telephone0733605140
        • emailzahida@qureshi.co.ke
        • created2020-04-13 06:42:02
        • modified2020-07-20 12:54:59
    • SiteDetail(array)
      • 0(array)
        • id717
        • application_id870
        • county_id15
        • site_nameMwingi Sub county (level 4 ) hospital
        • physical_addressMwingi
        • contact_detailsP.O. Box 16 -90400 Mwingi;mwingimedsupt@yahoo.com
        • contact_personDr Mutua -0722259210
        • site_capacity(null)
        • misc(null)
        • created2020-04-13 06:42:02
        • modified2020-07-20 12:54:59
        • County(array)
          • id15
          • county_nameKitui
          • created2012-06-15 10:23:48
          • modified2012-06-15 10:23:48
      • 1(array)
        • id728
        • application_id870
        • county_id19
        • site_nameNyeri Level 5 Hospital
        • physical_addressNyeri Town
        • contact_detailsP.O. Box 27-10100, Nyeri;pdhnyeri@yahoo.com
        • contact_personDr Juma Mwangi -0722639788
        • site_capacity(null)
        • misc(null)
        • created2020-04-14 13:59:55
        • modified2020-07-20 12:54:59
        • County(array)
          • id19
          • county_nameNyeri
          • created2012-06-15 10:24:16
          • modified2012-06-15 10:24:16
      • 2(array)
        • id729
        • application_id870
        • county_id7
        • site_nameGarissa county referral hospital
        • physical_addressGarissa
        • contact_detailsP.O. Box 29,70100-Garissa;pghgarissa@yahoo.com
        • contact_personDr. Fatuma Ibrahim Issa - 0714892300
        • site_capacity(null)
        • misc(null)
        • created2020-04-14 13:59:55
        • modified2020-07-20 12:54:59
        • County(array)
          • id7
          • county_nameGarissa
          • created2012-05-31 16:16:29
          • modified2012-05-31 16:16:29
      • 3(array)
        • id730
        • application_id870
        • county_id14
        • site_nameEmbu Level 5 hospital
        • physical_addressEmbu Town
        • contact_detailsP.O. Box 33, 60100-Embu;embupgh@gmail.com
        • contact_personDr. Mwebia - 0723391396
        • site_capacity(null)
        • misc(null)
        • created2020-04-14 13:59:55
        • modified2020-07-20 12:54:59
        • County(array)
          • id14
          • county_nameEmbu
          • created2012-06-15 10:23:42
          • modified2012-06-15 10:23:42
      • 4(array)
        • id731
        • application_id870
        • county_id22
        • site_nameTIGONI LEVEL 4 HOSPTIAL
        • physical_addressTigoni
        • contact_detailsP.O Box 124- 00217 Limuru;tighos2007@yahoo.co.uk
        • contact_personDr. Gitau - 0722417230
        • site_capacity(null)
        • misc(null)
        • created2020-04-14 13:59:55
        • modified2020-07-20 12:54:59
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 5(array)
        • id732
        • application_id870
        • county_id12
        • site_nameMeru Teaching and Referral Hospital
        • physical_addressMeru Town
        • contact_detailsP.O Box 8, 60200-Meru;hospitalmeru@yahoo.com
        • contact_personDr Consenta Gatumi - 0722339155
        • site_capacity(null)
        • misc(null)
        • created2020-04-14 13:59:55
        • modified2020-07-20 12:54:59
        • County(array)
          • id12
          • county_nameMeru
          • created2012-06-15 10:23:27
          • modified2012-06-15 10:23:27
      • 6(array)
        • id733
        • application_id870
        • county_id34
        • site_nameKitengela Sub county Hospital
        • physical_addressSaitoti Road
        • contact_detailsP.O Box 352- 00241 Kitengela
        • contact_personDr. Virginia Musau - 0720827222
        • site_capacity(null)
        • misc(null)
        • created2020-04-14 13:59:55
        • modified2020-07-20 12:54:59
        • County(array)
          • id34
          • county_nameKajiado
          • created2012-06-15 10:26:09
          • modified2012-06-15 10:26:09
      • 7(array)
        • id734
        • application_id870
        • county_id47
        • site_nameMbagathi County Hospital
        • physical_addressOff Mbagathi Road
        • contact_detailsP.O. Box 40205-00200 Nairobi
        • contact_personDr. Sr. Joan Thathi - 0731939300
        • site_capacity(null)
        • misc(null)
        • created2020-04-14 13:59:55
        • modified2020-07-20 12:54:59
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 8(array)
        • id735
        • application_id870
        • county_id37
        • site_nameKakamega County Government Referral Hospital
        • physical_addressKakamega Town
        • contact_detailsP.O Box P.O. Box 15 Kakamega;wpgh15@yahoo.com
        • contact_personDr. Geoffrey Matete - 0722233471
        • site_capacity(null)
        • misc(null)
        • created2020-04-14 13:59:55
        • modified2020-07-20 12:54:59
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
      • 9(array)
        • id759
        • application_id870
        • county_id47
        • site_nameSt. Mary\'s Mission Hospital
        • physical_addressLangata
        • contact_detailsP.O Box 3409 – 00506 Nairobi;smmh-rv@smmh.co.ke
        • contact_personDr. Victoria Muviku - 0720733494
        • site_capacity(null)
        • misc(null)
        • created2020-04-25 09:53:24
        • modified2020-07-20 12:54:59
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id422
        • application_id870
        • sponsorUniversity of Birmingham
        • sponsor_typeResearch Institution
        • contact_person
        • addressUniversity of Birmingham, Edgbaston
        • telephone_number+441214147618
        • fax_number
        • cell_number+447971823452
        • email_addressresearchgovernance@contacts.bham.ac.uk
        • created2020-04-13 06:42:02
        • modified2020-07-20 12:54:59
  • 4(array)
    • Application(array)
      • id403
      • user_id287
      • trial_status_id1
      • abstract_of_study<p>\n <strong>Background</strong></p>\n<p>\n Recent studies raise concerns that resistance against commonly used ACTs for the treatment of malaria in African countries may be emerging. Residual parasitaemia after treatment was found to be common in Western Kenya and associated with increased gametocyte carriage, a higher transmission potential and  an increased risk on recurrent parasitaemia. Therefore, not only the extensive monitoring of clearance dynamics is important, but also 1. the development and evaluation of alternative treatments and 2. the development of fast, easy-to-perform and sensitive diagnostics, capable of following parasite survival during and after treatment.</p>\n<p>\n One of these alternative treatments could be the combination of pyronaridine and artesunate (Shin Poong Pharmaceuticals). A child-friendly granule formulation (Pyramax) was developed for patients from the age of 3 months between 5 and 20 kg and has been shown to be well-tolerated and efficacious for the treatment of uncomplicated malaria in a phase III multicenter trial. dB-PCR-NALFIA is suggested as a suitable molecular tool to follow-up patients after treatment, as it is fast, sensitive and can be done in semi-field conditions.</p>\n<p>\n <strong>Objectives</strong></p>\n<p>\n Our objectives are:</p>\n<p>\n 1. To determine the efficacy of pyronaridine-artesunate (PA) compared to artemether-lumefantrine (AL), for the treatment of uncomplicated <em>falciparum </em>malaria in Kenyan children (primary objective);</p>\n<p>\n 2. To determine parasite clearance time after treatment by PA, compared to AL;</p>\n<p>\n 3. To determine the duration of gametocyte carriage after treatment by PA, compared to AL;</p>\n<p>\n 4. To determine the rate of gametocyte transmission to mosquitos after treatment by PA, compared to AL;</p>\n<p>\n 5. To determine the accuracy of dB-PCR-NALFIA compared to microscopy and real-time PCR;</p>\n<p>\n 6. To determine treatment efficacy and predict treatment outcome by dB-PCR-NALFIA, compared to real-time PCR and microscopy;</p>\n<p>\n 7. To determine the safety of pyronaridine-artesunate for the treatment of uncomplicated falciparum malaria in Kenyan children compared to that of artemether-lumefantrine.</p>\n<p>\n  </p>\n<p>\n <strong>Methods</strong></p>\n<p>\n The main study concerns a single-blind, randomised controlled non-inferiority trial in Mbita, Western Kenya. Children aged 6 months (and ≥5 kg) to 12 years will be randomly allocated to receive either PA or AL, and will be followed for 42 days. Finger-prick blood will be collected on day 0, 1, 2, 3, 7, 14, 28, and 42. On day 7, for children aged ≥2 years and only when additional informed consent is obtained, a 3ml venous blood sample will be collected instead of a finger-prick to determine transmission potential (objective 4). It is planned to include 225 children per intervention group. With this sample size it is possible to evaluate non-inferiority of PA compared to AL with a margin of 7% (corresponding to the absolute difference between groups), a one-sided alpha of 0.05 and a power of 91%. In the primary analysis non-inferiority of the PA group regarding the PCR-corrected ACPR-rate at day-28 compared to the AL group will be tested.</p>\n
      • study_title<p>\n Pyronaridine-artesunate and artemether-lumefantrine for the treatment of paediatric uncomplicated <em>falciparum</em> malaria in Western Kenya</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/06/01
      • version_no6
      • date_of_protocol13-04-2015
      • study_drugPyronaridine-Artesunate (Pyramax)
      • 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_namePyronaridine-Artesunate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressj.roth@kit.nl
      • 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_applicantJohanna Roth
      • declaration_date104-06-2015
      • declaration_principal_investigatorDr. Patrick Sawa
      • declaration_date204-06-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Children between 6 months and 12 years old, with a body weight of ≥5 kg;</li>\n <li>\n Living in the catchment area of the study (within a radius of ~10 km from St. Jude’s Clinic);</li>\n <li>\n Having microscopically confirmed <em>P. falciparum</em> mono-infection (asexual parasite density 1,000-200,000 µL^-1).</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Signs and symptoms of severe malaria (according to WHO criteria for severe malaria, (WHO 2012)) or any other severe illness necessitating parenteral treatment;</li>\n <li>\n Mixed <em>Plasmodium </em>infection;</li>\n <li>\n Clinically suspected (oedema, jaundice and/or ascites) or reported hepatic and/or renal impairment (any cause, as reported by parents/guardians and/or evident from medical history);</li>\n <li>\n Having anaemia  with an Hb <6 g/dL;</li>\n <li>\n Evidence of severe malnutrition (severe wasting: z-score weight for age <-3 and severe stunting: z-score height for age <-3 (WHO 2009b));</li>\n <li>\n Having received anti-malarial therapy in the previous two weeks;</li>\n <li>\n Known history of hypersensitivity, allergic or adverse reactions to artesunate, artemether-lumefantrine or other artemisinins;</li>\n <li>\n Participating in other anti-malarial drug intervention studies;</li>\n <li>\n Previous participation in the PAAL study, e.g. in the previous transmission season (each individual child can only take part in this study once);</li>\n <li>\n Not being available for follow-up.</li>\n</ul>\n
      • primary_end_points<p>\n The primary outcome is the PCR-corrected adequate clinical and parasitological response (ACPR) on day 28, as indicated by negative microscopy.</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n This is a research clinic that has carried out multiple clinical trials over the last 8 years.</p>\n<p>\n Run by a medical team consisting of 1 doctor, 1 nurse, 2 medical laboratory technologists, a radiographer and a pharmacy technologist, this is a comprehensive outpatient clinic designed to offer high quality medical care to Icipe scientists, support staff and their families as well as the local community.</p>\n<p>\n We have the capacity to manage any acute medical emergencies as required. In case the required care is beyond our capacity, the local District hospital is 2km away.</p>\n<p>\n The hospital is fully equipped and also has a capacity to offer observation ward capacity where necessary.</p>\n<p>\n For research activities such as the upcoming PA-AL Study, we engage an independent research team to carry out the study in coordination with the existing clinic team. For this study we will engage at the very least, a study coordinator, a study nurse, 2 laboratory technologists and field workers.</p>\n
      • other_details_explanation<p>\n Malaria non-endemic in host country.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KEMRI - Scientific and Ethics Review Unit (SERU). Approval granted on May 7th 2015. Single site.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration9 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorArtemether-Lumefantrine
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaSt. Judes Clinic, ICIPE
      • single_site_physical_addressP. O. Box 30, Mbita 40305, Kenya
      • single_site_contact_personDr. Patrick Sawa
      • single_site_telephone+254722369254
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site450
      • total_participants_worldwide450
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyYoung children
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameHenk
      • investigator1_middle_name
      • investigator1_family_nameSchallig
      • investigator1_qualificationPhD
      • investigator1_professional_addressMeibergdreef 39, 1105AZ, Amsterdam
      • investigator1_telephone+31(0)205665447
      • investigator1_emailh.schallig@kit.nl
      • organisations_transferred_Yes
      • number_participants450
      • notification
      • approval_date04-09-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-06-2015
      • 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)
      • modified2016-09-20 10:48:05
      • created2015-06-04 10:26:17
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id276
        • application_id403
        • given_namePatrick
        • middle_name
        • family_nameSawa
        • qualificationDr.
        • professional_addressSt. Jude’s Clinic ICIPE, P. O. Box 30, Mbita 40305, Kenya
        • telephone+245722369254
        • emailpsawa@icipe.org
        • created2015-06-04 10:35:55
        • modified2015-06-05 16:22:04
    • SiteDetail(array)
      • 0(array)
        • id329
        • application_id403
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-06-04 10:35:55
        • modified2015-06-05 16:22:04
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id213
        • application_id403
        • sponsorRoyal Tropical Institute, KIT Biomedical Research
        • sponsor_type(null)
        • contact_personJ.M. Roth
        • addressMeibergdreef 39, 1105 AZ, Amsterdam, The Netherlands
        • telephone_number+31(0)205665442
        • fax_number
        • cell_number+31(0)613691166
        • email_addressj.roth@kit.nl
        • created2015-06-04 10:35:55
        • modified2015-06-05 16:22:04
• 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