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    • Application(array)
      • id854
      • user_id606
      • trial_status_id7
      • abstract_of_study<p>\n Background:  Vincristine is among the most widely used and potentially effective chemotherapeutic agents in pediatric oncology patients. However, in black African children it is often sub optimally dosed due to genetic differences in the metabolism of vincristine. This study aims to optimize the dosing regimen of vincristine using therapeutic drug monitoring while carefully monitoring toxicity.</p>\n<p>\n Design This will be a prospective cohort study. All children aged 2-14 years diagnosed with cancer and scheduled to receive vincristine can be included. After the administration of vincristine, blood samples will be taken. These will be shipped to and analyzed in the Netherlands to determine the vincristine concentration in each sample. Based on this, a dose advise will be given for subsequent vincristine administrations. This cycle will be repeated in total 3 times. Toxicity will be monitored by determination of the bilirubin, by questionnaires and by physical examination to check for signs of peripheral neuropathy. </p>\n<p>\n Results We aim to include 100 patients. The required dose to achieve a therapeutic vincristine level, will be compared to a historic cohort. The results will lead to an alteration in the dosing regimen of vincristine in all pediatric oncology patients in Kenya. </p>\n
      • study_title<p>\n CHildren treated with vincristine: A trial regarding Pharmacokinetics, DNA And Toxicity of targeted therapy In pediatric oncology patients.</p>\n
      • laymans_summary<p class=\"yiv4801908789\">\n <span style=\"font-size:12px;\"><span style=\"color: rgb(29, 34, 40);\">The aim of the study is to optimize treatment and improve survival for children on treatment for cancer by maximizing the use of Vincristine, a drug which is used in treatment of childhood cancer.</span></span></p>\n<p class=\"yiv4801908789\">\n <span style=\"font-size:12px;\"><span style=\"color: rgb(29, 34, 40);\">Baseline assessment to check presence of nerve injury, bilirubin levels and malnutrition will be done before 1st administration of regular Vincristine dose. Blood sample will be obtained by a finger prick for analysis of Vincristine concentration after the dose has been given. The dose of Vincristine will  be increased during the next administration when the Vincristine concentration below the level calculated as safe and in the absence of severe vincristine induced peripheral neuropathy or any other severe side effect. A second, third and fourth dose adaptation will be given if the above criteria is met after each dose adaptation. </span></span></p>\n<p class=\"yiv4801908789\">\n <span style=\"font-size:12px;\"><span style=\"color: rgb(29, 34, 40);\">The information from this study might lead to a change in treatment of a wide range of cancers for black African children worldwide, by demonstrating that these children benefit from higher doses of VCR without severely increasing Vincristine induced peripheral neuropathy</span></span>.</p>\n<style type=\"text/css\">\n</style>\n
      • short_titleCHAPATI
      • protocol_noECCT/22/03/05
      • version_no01/2020
      • date_of_protocol05-12-2019
      • study_drugVincristine
      • disease_conditionAcute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, Rhabdomyosarcoma, Neuroblastoma, Nephroblastoma, Retinoblastoma
      • product_type_biologicals0
      • product_type_proteins0
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      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameVincristine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresskugolinet@gmail.com
      • applicant_covering_letter1
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      • declaration_applicantSandra Langat
      • declaration_date117-03-2022
      • declaration_principal_investigatorDr. Festus Muigai Njuguna
      • declaration_date217-03-2022
      • placebo_presentNo
      • study_objectives<p>\n 1. To determine the optimal vincristine dose among children receiving chemotherapy at MTRH </p>\n<p>\n 2. To evaluate the development and severity of peripheral neuropathy and liver toxicity in paediatric oncology patients receiving  optimized vincristine doses in MTRH</p>\n<p>\n 3. To study genetic variants that are associated with vincristine metabolism as well as the  development and severity of peripheral neuropathy </p>\n
      • principal_inclusion_criteria<p>\n 1. Black patients aged 2-14 years with a malignancy for which they are scheduled to receive a minimum of four VCR administrations as part of their treatment protocol: children who are treated for acute lymphoblastic leukemia, children who are treated for non-Hodgkin's lymphoma, children who are treated for rhabdomyosarcoma,  children who are treated for neuroblastoma, children who are treated for nephroblastoma and children who are treated for retinoblastoma</p>\n<p>\n 2.  Written informed consent </p>\n
      • principal_exclusion_criteria<p>\n  1. Severe malnutrition (Z score ≤2SD of weight for height)</p>\n<p>\n  2. Total bilirubin >3 times upper limit of normal</p>\n<p>\n  3. Pre-existent severe mental retardation e.g. Down syndrome </p>\n
      • primary_end_points<p>\n 1. Vincristine Induced Peripheral Neuropathy</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
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      • trial_therapeutic_exploratory0
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      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n We have 4 main staff members including a pediatrician, pharmacist, study coordinator and data assistant. The site facility is in a level six hospital, in a well equiped and aqequately staffed paediatric oncology ward.</p>\n<p>\n 1. Dr. Festus Njuguna - Pediatrician - Master of Medicine (Paediatrics) (2005-2008), Bachelor of Medicine and Bachelor Surgery (1994-2000). Has over ten years working experince as a paediatrician and 8 years as a researcher in the pediatric oncology field</p>\n<p>\n 2. Dr. Linet Kugo - Pharmacist - Master of Pharmacy (Epivigil) (2013-2015); Bachelor of Pharmacy (2004-2008); 4 years experience as an oncology pharmacist with over 10 years experince as a pharmacist.</p>\n<p>\n 3. Sandra Langat - Study Coordinator - Bsc. in Medical Microbiology (2004-2007), 11 years working experinece in data collection and research coordination.</p>\n<p>\n 4. Martha Kipngetich - Data Assistant - Diploma in Information Technology (2002-2003), BSc. in Information Technology (2014 - 2015), 10 years working experience in data management, IT administration and research.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • 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_duration2 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
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      • single_site_member_stateYes
      • location_of_areaMoi Teaching and Referral Hospital
      • single_site_physical_addressNandi Road, Eldoret, Kenya
      • single_site_contact_personDr. Festus Muigai Njuguna
      • single_site_telephone0721219761
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwide100
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • 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_specifyAll the study subjects will be below 18 years hence consent will be given by their parents or legal guardians on their behalf.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFESTUS
      • investigator1_middle_nameMUIGAI
      • investigator1_family_nameNJUGUNA
      • investigator1_qualificationPEDIATRICIAN
      • investigator1_professional_addressMOI UNIVERSITY SCHOOL OF MEDICINE
      • investigator1_telephone0721219761
      • investigator1_emailmuigaifes2000@yahoo.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date25-10-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-03-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
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      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed
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      • balance_site(null)
      • final_date(null)
      • modified2024-02-26 10:55:08
      • created2020-02-20 09:03:12
      • total_sites(null)
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        • id525
        • application_id854
        • given_nameFESTUS
        • middle_nameMUIGAI
        • family_nameNJUGUNA
        • qualificationPEDIATRICIAN
        • professional_addressMOI UNIVERSITY SCHOOL OF MEDICINE
        • telephone0721219761
        • emailmuigaifes2000@yahoo.com
        • created2020-02-20 09:21:18
        • modified2022-03-18 11:29:10
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        • created2020-02-20 09:21:18
        • modified2022-03-18 11:29:10
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id412
        • application_id854
        • sponsorPrincess Maxima Paediatric Oncology Center
        • sponsor_typeResearch Institution
        • contact_personProf. Gertjan Kaspers
        • addressHeidelberglaan 25, 3584 CS Utrecht, Netherlands
        • telephone_number+31889728751
        • fax_number
        • cell_number+31625710324
        • email_addressG.J.L.Kaspers@prinsesmaximacentrum.nl
        • created2020-02-20 09:21:18
        • modified2022-03-18 11:29:10
  • 1(array)
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      • id1489
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      • abstract_of_study<div>\n <strong>Title:</strong> Delivery strategies for malaria chemoprevention in the post-discharge management of hospitalised children with severe anaemia or severe malaria: cluster and individually randomised controlled implementation trials with nested economic evaluation in Kenya and Benin.</div>\n<div>\n Short Title: PDMC-Saves Lives (PDMC-SL)</div>\n<div>\n <strong>Background and rationale:</strong> In June 2022, the World Health Organization (WHO) recommended PDMC for the post-discharge management of children with severe anaemia in settings with moderate to high perennial malaria transmission to reduce hospital readmissions and deaths after discharge. However, there is no obvious delivery platform for PDMC, unlike for intermittent preventive treatment in infants (IPTi) or pregnant women (IPTp). Furthermore, a potential limitation of PDMC is adherence to the 3-day dosing regimen, which is provided monthly three times after discharge. Therefore, implementation research is urgently needed to support the introduction and scale-up of PDMC. We propose to conduct two implementation trials to evaluate delivery strategies to optimise adherence to PDMC in different contexts: one in East Africa (Kenya) and one in West Africa (Benin). The actual interventions to be evaluated differ between the two trials as they have been co-designed with national stakeholders during an initial formative research stage, conducted under a separate protocol (LSTM Protocol #23-053, KEMRI-SERU #480/4870).</div>\n<div>\n <strong>Aim:</strong> To conduct implementation trials, co-designed with national stakeholders, to evaluate different delivery strategies to optimise health system delivery of PDMC drugs and adherence to PDMC to provide evidence-based data including acceptability, feasibility and cost-effectiveness that are useful to decision-makers.</div>\n<div>\n Study Type: Kenya: A multi-centre, 2-arm, cluster-randomised trial evaluating two health system delivery strategies and a 3-arm nested individually randomised trial evaluating two new intervention strategies to enhance end-user adherence to PDMC compared to the standard of care without adherence strategies. Benin: A multi-centre, 3-arm, individually randomised trial evaluating two intervention strategies to enhance end-user adherence to PDMC compared to a control arm of PDMC without specific adherence support strategies.</div>\n<div>\n <strong>Sites: </strong>Health facilities with blood transfusion services in malaria-endemic areas in Benin and western Kenya.</div>\n<div>\n <div>\n Study Population:</div>\n <div>\n <strong>Clusters (Kenya only) inclusion criteria:</strong> health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria. Exclusion criteria: primary health facilities without subservient lower-level health facilities. Individuals (Kenya and Benin) inclusion criteria: convalescent children aged <10 years, weighing ≥5 kg admitted with severe anaemia (haemoglobin<5g/dL) or severe malaria; clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL. Exclusion criteria: blood loss due to trauma, malignancy, known bleeding disorders or sickle cell disease, known hypersensitivity to study drug, known heart conditions, non-resident in the study area, previous participation in the study, known need at enrolment for prohibited medication and scheduled surgery during the 4-month course of the study. HIV infection and cotrimoxazole prophylaxis are not exclusion criteria.</div>\n <div>\n <strong>Study Interventions:</strong></div>\n <div>\n Cluster randomised trial (Kenya only): Hospitals will be randomised to one of two delivery platforms for PDMC (A or B). The choice of the two delivery strategies to be evaluated has been informed by formative research conducted under a separate standalone protocol (LSTM Protocol #23-053, KEMRI-SERU #480/4870) and stakeholder engagements. Strategy A comprises delivery of the initial PDMC course at the primary admitting facility two weeks after discharge during a post-discharge follow-up clinic visit. The subsequent 2 courses will be dispensed monthly at the closest health facility. Strategy B comprises delivery of all 3 PDMC courses at the primary admitting facility two weeks after discharge during a post-discharge follow-up clinic visit.</div>\n <div>\n Individually randomised trial (Kenya and Benin): The final choice of the adherence support strategies to be evaluated has been informed by formative research conducted under the same separate standalone protocol. In Kenya, these include: Arm a - SMS reminders to caregivers, Arm b - Community Health Promoter (CHP) support through monthly home visits and Arm c - no reminders (control). In Benin, these include: Arm a- a telephone reminder to the community health worker (CHW)/qualified community health worker (ASCQ); Arm b - regional social mobilisation research and support officer (CRAMS) reminder through monthly visits to CHW/ASCQ; and Arm c - no reminder (control).</div>\n <div>\n All participating children will receive standard in-hospital care for severe anaemia or severe malaria (blood transfusion, often combined parenteral artesunate, followed by a 3-day course of AL whether they initially had malaria or not), which will be started in-hospital as soon as they are able to take oral medication. Many children are likely to receive parenteral antibiotics as well as part of the standard of care.</div>\n <div>\n <strong>Endpoints:</strong> Cluster randomised trial (Kenya only): The primary endpoint will be the proportion of eligible participants who were not prescribed the full 3 courses of dpoints:PDMC. Individually randomised trial (Kenya and Benin): Primary endpoint: proportion of children with incomplete adherence to the 9 doses of PDMC (three courses of 3-day treatments 3x3=9). Secondary endpoints include 1) clinical effectiveness (all-cause and malaria-specific sick-child clinic visits, all-cause and cause-specific readmissions and all-cause mortality by the end of week 14 after discharge, 2) safety (incidence of serious adverse events), 3) cost-effectiveness, and 4) acceptability and feasibility.</div>\n <div>\n <strong>Follow-up procedures:</strong> Children will be followed for 14 weeks (i.e., four weeks after the last PDMC course) through passive surveillance of clinic visits and hospitalisations. Each child will then be seen for an end-of-study visit towards the end of week 14. Children will also be visited at home for unannounced home visits one to three days from the last day of the last dose of each 3-day course of PDMC medication to assess adherence.</div>\n <div>\n Sample size: Cluster randomised trial (Kenya only): Approximately 60 participants per cluster (cluster size will vary between clusters), or approximately 600 overall (300 in each of the two study arms) is estimated to provide over 80% power to detect a risk difference of 20% from 35% in the control arm to 15% in the intervention clusters (RR=0.43), using a two-sided alpha of 0.05, and assuming an intra-cluster correlation coefficient (ICC) of 0.03, a coefficient of variation of 0.39,15% loss to follow-up and small-sample correction to account for the small number of clusters. Individually randomised trial (Kenya and Benin): A sample size of 147 participants in the control arm (c) and 147 in each of the two intervention arms (a and b), totalling 441 participants, would provide 90% power to detect a 50% reduction in the primary endpoint (proportion of children with incomplete adherence to the 9 doses of PDMC) from 36.8% in the control arm to 18.4% (RR=0.50) in any of the two intervention arms using a 1:1:1 allocation after accounting for the multiple comparisons (α = 0.025). A total of 519 participants (173 per arm) will be recruited to allow for a 15% loss to follow-up.</div>\n <div>\n <strong>Data Analysis:</strong> Risk ratios and corresponding 95% confidence intervals will be computed to compare treatment effects using multi-level mixed models (Kenya) or mixed models (Benin) accounting for clustering effects.</div>\n <div>\n <strong>Partners institutions</strong>: IRCB, Benin; KEMRI Kisumu, Kenya; LSTM, UK; Epicentre, France; IRD, France; Centers for Disease Control and Prevention, US; TRUE, Malawi.</div>\n</div>\n<div>\n  </div>\n
      • study_title<p>\n Delivery strategies for malaria chemoprevention in the post-discharge management of hospitalised children with severe anaemia or severe malaria: cluster and individually randomised controlled implementation trials with nested economic evaluation in Kenya and Benin</p>\n
      • laymans_summary<div>\n <strong>Background:</strong> The World Health Organization (WHO) recommended post-discharge malaria chemoprevention (PDMC) in June 2022 for managing children with severe anaemia in areas with moderate to high perennial malaria transmission. The goal is to reduce hospital readmissions and deaths after discharge. However, there is no clear delivery platform for PDMC, and adherence to the 3-day dosing regimen, provided monthly three times after discharge, is a potential limitation. Implementation research is necessary to support the introduction and scale-up of PDMC.</div>\n<div>\n <strong>Aim: </strong>Implementation trials in Kenya and Benin will be co-designed with national stakeholders to evaluate alternative health system delivery strategies for optimizing delivery of PDMC drugs and adherence to PDMC. The trials will provide evidence on the acceptability, feasibility, and cost-effectiveness of each strategy to inform effective implementation and scale-up of PDMC in different country and health system contexts.</div>\n<div>\n <strong>Methods:</strong> The project involves two separate trials, one in each country. Formative research with the Ministries of Health in the two countries and their stakeholders has informed the delivery strategy interventions selected to be evaluated in each trial. In Kenya, a multi-centre, 2-arm cluster randomised trial will compare two “delivery strategies” for the 3 courses of monthly PDMC with dihydroartemisinin-piperaquine (DP). The trial will randomize 10 hospitals (the clusters) to one of two delivery platforms (A and B) in a 1:1 ratio, with the final choice of intervention informed by formative research. The primary endpoint will be the proportion of eligible participants prescribed with incomplete courses of PDMC. A nested 3-arm individually randomised trial involving 600 children ( 200 per arm) will evaluate 3 different “adherence support” strategies, including SMS reminders to caregivers, Community Health Worker (CHW) support through home visits, and a control arm comprising of provision of all 3 PDMC courses by the hospital where the child was admitted i.e. standard of care. The primary endpoint will be the proportion of children with incomplete adherence (i.e. not receiving all 9 doses of PDMC).</div>\n<div>\n Secondary endpoints include clinical effectiveness, cost-effectiveness, acceptability and feasibility, provision of adherence support mechanisms, and linkage to subsequent levels of service provision along the PDMC delivery continuum. All participating children will receive standard in-hospital care for severe anaemia or severe malaria and a 3-day course of artemether-lumefantrine (AL), started in-hospital as soon as they can take oral medication.</div>\n<div>\n In Benin, a 3-arm individually randomised trial involving 519 children (173 per arm) will be conducted to evaluate different “adherence support” strategies only, including: mobile phone reminders to CHW/ASCQ , monthly reminder visits to CHW/ASCQ by the regional social mobilisation research and support officer (CRAMS), and a control arm without any reminder intervention.</div>\n<div>\n LSTM-UK will act as the legal sponsor of the trials in Kenya. The Institut de Recherche Clinique du Bénin (IRCB) will act as the sponsor for the trial in Benin.</div>\n
      • short_titlePDMC-Saves Lives (PDMC-SL)
      • protocol_noECCT/24/12/01
      • version_no1.3
      • date_of_protocol06-09-2024
      • study_drugDihydroartemisinin-piperaquine
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDihydroartemisinin-piperaquine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressruth.njoroge@ke.lstmed.ac.uk
      • 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)
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      • declaration_applicantDr. Ruth Njoroge - Pharmacist
      • declaration_date105-12-2024
      • declaration_principal_investigatorDr. Juliet Otieno Awori - Principal Investigator
      • declaration_date205-12-2024
      • placebo_presentNo
      • study_objectives<div>\n <div>\n <strong>Primary Objectives</strong></div>\n</div>\n<div>\n <strong>1. Cluster RCT of health systems delivery mechanism:</strong></div>\n<div>\n - To determine the effectiveness of different delivery strategies to optimise health system delivery of PDMC</div>\n<div>\n <div>\n <strong>2. Individually RCT of end-user adherence support</strong></div>\n <div>\n - To determine the effectiveness of different adherence support strategies to optimise end-user adherence to PDMC</div>\n <div>\n  </div>\n <div>\n <strong>Secondary Objectives</strong></div>\n</div>\n<div>\n <strong>1. Cluster RCT of health systems delivery mechanism:</strong></div>\n<div>\n - To evaluate the adoption of the health system delivery mechanisms and adherence support mechanisms for the 3 courses of PDMC</div>\n<div>\n <div>\n <strong>2. Individually RCT of end-user adherence support:</strong></div>\n <div>\n To determine the clinical effectiveness of the different PDMC delivery strategies (all-cause and malaria-specific readmissions and sick-child clinic visits, all-cause mortality).</div>\n <div>\n 3. To evaluate the effectiveness of the linkage mechanisms between the various health facility levels along the PDMC delivery continuum</div>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. Aged <10 years of both sexes</div>\n<div>\n 2. Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin <5.0 g/dl or PCV <15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and the presence of microscopy or RDT confirmed Plasmodium infection</div>\n
      • principal_exclusion_criteria<div>\n 1. Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)</div>\n<div>\n 2. Sickle cell anaemia/sickle cell disease</div>\n<div>\n 3. Body weight <5 kg</div>\n
      • primary_end_points<div>\n 1. The proportion of participants receiving an incomplete set of PDMC courses</div>\n<div>\n 2. The proportion of participants with incomplete adherence to the 9 doses of PDMC</div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n <strong>INVESTIGATORS AND INSTITUTIONS</strong></div>\n<div>\n <strong>Chief Investigators</strong></div>\n<div>\n Dr Jenny Hill, PhD - Liverpool School of Tropical Medicine (LSTM)</div>\n<div>\n Prof Feiko ter Kuile, MD, PhD - KEMRI/CDC and LSTM</div>\n<div>\n <strong>Country Principal Investigator</strong></div>\n<div>\n Dr Juliet Otieno Awori, MBChB, PhD - Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n <strong>Country Co- Principal Investigator</strong></div>\n<div>\n Dr Simon Kariuki, PhD - Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n <strong>Co-Investigators</strong></div>\n<div>\n Dr Titus Kwambai, MBChB, PhD - Centers for Disease Control and Prevention, Kenya (CDC-Kenya), KEMRI Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n Dr. Ruth Njoroge, BPharm, Dr Prisca Oria, PhD - Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n Dr Eve Worrall, PhD, Carole Khairallah, Jenna Hoyt, Dr Tao Chen, MD, MSc, PhD, Amanda McCoy, MSc - Liverpool School of Tropical Medicine (LSTM)</div>\n<div>\n <strong>Collaborators</strong></div>\n<div>\n Dr. Sammy Mahugu, MBChB, MPH,MBA, Ms. Regina Kandie, MSc - Ministry of Health Kenya, National Malaria Control Programe</div>\n<div>\n Dr Valérie Briand, Dr Adrian Luty - Epicentre, Paris, France</div>\n<div>\n Prof Kamija Phiri, MD, PhD; Dr Lucinda Manda-Taylor - Training Research Unit of Excellence, Blantyre, Malawi</div>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration17 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorDiff. delivery strategies
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaHealth facilities with blood transfusion services in malaria-endemic areas in Western Kenya
      • single_site_physical_addressKEMRI-CGHR P.O. Box 1578-40100, Kisumu, Kenya.
      • single_site_contact_personJuliet Otieno Awori
      • single_site_telephone+254721432548
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listKenya\nBenin
      • data_monitoring_committeeYes
      • total_enrolment_per_site600
      • total_participants_worldwide1119
      • 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_specifyChildren aged under 10 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFeiko
      • investigator1_middle_nameter
      • investigator1_family_nameKuile
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressKEMRI CGHR 1578-40100 Kisumu, Kenya
      • investigator1_telephone+254708739228
      • investigator1_emailFeiko.terkuile@lstmed.ac.uk
      • organisations_transferred_No
      • number_participants600
      • notification
      • approval_date16-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-12-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted05-12-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have ben addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-05-07 15:02:00
      • created2024-11-18 15:41:01
      • total_sites1
      • ecitizen_invoice330507
    • InvestigatorContact(array)
      • 0(array)
        • id1202
        • application_id1489
        • given_nameJuliet
        • middle_nameOtieno
        • family_nameAwori
        • qualificationMBChB
        • professional_addressKEMRI CGHR 1578-40100 Kisumu, Kenya
        • telephone+254721432548
        • emailJuliet.Otieno@lstmed.ac.uk
        • created2024-12-04 16:37:28
        • modified2025-02-03 10:22:51
      • 1(array)
        • id1203
        • application_id1489
        • given_nameSimon
        • middle_name
        • family_nameKariuki
        • qualificationPhD
        • professional_addressKEMRI CGHR 1578-40100 Kisumu, Kenya
        • telephone+254725389246
        • emailskariuki1578@gmail.com
        • created2024-12-05 11:57:10
        • modified2025-02-03 10:22:51
    • SiteDetail(array)
      • 0(array)
        • id1825
        • application_id1489
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2024-12-04 16:37:28
        • modified2025-02-03 10:22:51
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id795
        • application_id1489
        • sponsorLiverpool School of Tropical Medicine (LSTM
        • sponsor_typeResearch Institution
        • contact_personProf Feiko ter Kuile, MD, PhD
        • addressPembroke Place, Liverpool L3 5QA, UK.
        • telephone_number+44 0151 7053794
        • fax_number
        • cell_number+44 0151 7053794
        • email_addresslstmgov@lstmed.ac.uk
        • created2024-12-04 16:37:28
        • modified2025-02-03 10:22:51
  • 2(array)
    • Application(array)
      • id129
      • user_id21
      • trial_status_id5
      • abstract_of_study<p>\n This is a three arm parallel group, open-label, multi-centre, randomised controlled trial</p>\n<p>\n The trial aims to determine whether, in patients failing a first-line NRTI and NNRTI-containing regimen:</p>\n<ol>\n <li>\n the use of bPI plus raltegravir (an integrase inhibitor) is superior to standard of care (bPI plus 2 new NRTIs) in achieving good HIV disease control at 96 weeks after randomisation.</li>\n <li>\n the use of bPI monotherapy is non-inferior to standard of care in achieving good HIV disease control at 96 weeks after randomisation.</li>\n</ol>\n<p>\n 1200 patients will be included in the study</p>\n<p>\n Patients will be randomised in a ratio of 1:1:1 to one of the following three treatment arms.</p>\n<ul>\n <li>\n  Arm A: bPI + 2 NRTIs* chosen by clinician according to local standard of care and availability</li>\n <li>\n Arm B: bPI + raltegravir 400 mg twice daily</li>\n <li>\n Arm C:bPI alone (after an initial 12-week induction phase with raltegravir)</li>\n</ul>\n<p>\n The bPI will be standardised to Aluvia (lopinavir/ritonavir 400 mg/100 mg b.d.).</p>\n<p>\n The trial will have a 12 months recruitment period and each patient will be followed for 144 weeks</p>\n<p>\n Good HIV disease control at 96 weeks defined as a composite endpoint consisting of all of:</p>\n<ul>\n <li>\n No new WHO Stage 4 events between randomisation and week 96 (other than oesophageal candidiasis or mucosal HSV which are recognised to be less severe conditions, see p55) AND</li>\n <li>\n CD4 count > 250 cells/mm3 at week 96 AND</li>\n <li>\n VL < 10,000 copies/ml or > 10,000 copies/ml with no PI resistance mutations at week 96</li>\n</ul>\n
      • study_title<p>\n EARNEST : Europe -Africa Research Network for Evaluation of Second-line Therapy</p>\n<p>\n  </p>\n<p align=\"center\">\n <strong> </strong></p>\n
      • laymans_summary(null)
      • short_titleEARNEST
      • protocol_noECCT/11/01/02
      • version_no3.0
      • date_of_protocol06-09-2010
      • study_drugRaltegravir,Aluvia
      • disease_conditionSecond line treatment of HIV
      • 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 and Lopinavir/Ritonavir
      • 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_date122-05-2013
      • declaration_principal_investigatorAbraham M Siika, MBChB, MMed, Msc - Site Principal Investigator
      • declaration_date222-05-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Previously documented HIV infection on at least one standard antibody-based test.</li>\n <li>\n Age 12 years and above</li>\n <li>\n Taking 2NRTI + NNRTI-based regimen continuously for a total period of at least 12 months</li>\n <li>\n Naïve to protease inhibitor therapy</li>\n <li>\n Good adherence to ART, defined as missing medication on no more than 3 days in the prior month (patients who do not have good adherence should be given adherence counselling and re-assessed after an appropriate time interval of not less than 4 weeks).</li>\n <li>\n HIV treatment failure defined by the one or more of the following clinical, immunological and virological criteria (modified from WHO 2010 criteria):</li>\n</ol>\n<p>\n <strong>CLINICAL</strong><br />\n A1 and A2 and A3 must be fulfilled:<br />\n A1: New or recurrent WHO stage 4 condition occurring after at least 12 months on ART<br />\n A2: CD4 cell count < 200 cells/mm3 after at least 12 months on ART, and confirmed at<br />\n screening<br />\n A3: VL > 400 copies/ml at screening<br />\n AND/OR</p>\n<p>\n <br />\n <strong>IMMUNOLOGICAL</strong><br />\n (B1 or B2 or B3) and B4 must be fulfilled<br />\n B1: Fall of CD4 count to pre-therapy baseline (or below) after at least 12 months on ART and confirmed at screening<br />\n B2: Fall of CD4 count from previous value > 400 cells on treatment to <200 cells/mm3 after at least 12 months on ART and confirmed at screening<br />\n B3: CD4 count < 100 cells/mm3 after at least 12 months on ART and confirmed at screening<br />\n AND<br />\n B4: VL > 400 copies/ml at screening<br />\n AND / OR</p>\n<p>\n <br />\n <strong>VIROLOGICAL</strong><br />\n VL >5,000 copies/ml after at least 6 months on ART, and confirmed at screening after at<br />\n least 12 months on ART</p>\n<ol start=\"7\">\n <li>\n Willing and able to provide written informed consent</li>\n <li>\n Able to attend for regular study follow-up visits</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Any major clinical contraindications to the use of bPI, the NRTIs that are available to be selected for a second-line regimen, or raltegravir</li>\n <li>\n Known Hepatitis B carrier (Hepatitis B surface antigen positive if tested)</li>\n <li>\n Requirement for concomitant medication with known major interactions with study drugs for which drug substitutions or dose alterations are not available or acceptable.</li>\n <li>\n Women who are currently pregnant or breastfeeding</li>\n <li>\n Current participation in another clinical trial or research protocol (may be permitted in some circumstances; see CRF helpfile for list of studies pre-approved by the EARNEST Trial Management Group), but must first be discussed with the EARNEST Trial Management Group via the MRC CTU)</li>\n <li>\n Life expectancy of less than one month in the opinion of the treating physician</li>\n</ol>\n
      • primary_end_points<p>\n Good HIV disease control at week 96<br />\n This is a composite endpoint defined as:</p>\n<p>\n <br />\n • No new or recurrent WHO Stage 4 events between randomisation and week 96 (other than oesophageal candidiasis or mucosal HSV which are recognised to be less severe conditions, see page 43)</p>\n<p>\n AND<br />\n • CD4 count > 250 cells/mm3 at week 96</p>\n<p>\n AND<br />\n • VL < 10,000 copies/ml or
        10,000 copies/ml with no PI resistance mutations at<br />\n week 96</p>\n
      • scope_diagnosis1
      • 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_confirmatory0
      • 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- Investigator</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 Priscilla Cheruiyot, BScN, MPH- Site Coordinator</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 Following the massive rollout of ART in Africa, large numbers of people are receiving first-line ART, and over the coming few years an increasing number will be developing treatment failure and requiring second-line therapy. There is an urgent need to develop the evidence base for second-line therapy in Africa and other low-income countries where there is extensive NRTI and NNRTI resistance at the time of failure and where program and resource limitations mean that a single uniform second-line treatment (rather than individualised patient treatment) is likely to be the only feasible management approach. The considerably higher costs of second-line therapy present a further imperative for optimising the use of the drugs in this setting and needed.</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). Continuing review granted on 28 Nov 2012.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration144 weeks of follow up
      • 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_comparatorArm B: bPI + raltegravir
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaMoi University Clinical Research Centre
      • single_site_physical_address(null)
      • single_site_contact_person(null)
      • single_site_telephone(null)
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites
      • multi_country_listkenya, Uganda, Zimbabwe, Malawi,Zambia,
      • data_monitoring_committeeYes
      • total_enrolment_per_siteOnly 52 Enrolled
      • total_participants_worldwide1200
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_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_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailamsiika@africaonline.co.ke
      • organisations_transferred_No
      • number_participantsEnrollment is closed with 52 participants having been enrolled
      • notification
      • approval_date06-09-2010
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-05-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The newsletter (attached below) and the presenation by Prof Nick Paton (also attached) give a brilliant summary.<br />\n  </p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-03-26 12:25:13
      • created2013-04-26 09:05:31
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id77
        • application_id129
        • given_nameAbraham
        • middle_nameMosigisi
        • family_nameSiika
        • qualificationMBChB, MMed, MSc
        • professional_addressP O Box, 4606-30100, Eldoret
        • telephone0721280785
        • emailamsiika@africaonline.co.ke
        • created2013-04-29 11:57:04
        • modified2013-05-22 12:07:36
    • SiteDetail(array)
      • 0(array)
        • id99
        • application_id129
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-04-29 11:57:25
        • modified2013-05-22 12:07:36
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id61
        • application_id129
        • sponsorMedical Research Council
        • sponsor_type(null)
        • contact_personDr. Nicholas Paton
        • address20 Park Crescent Road,London, W1B 1AL, UK
        • telephone_number+44 20 7670 4808
        • fax_number
        • cell_number+44 20 7670 4808
        • email_addressnick.paton@ctu.mrc.ac.uk
        • created2013-04-29 11:57:25
        • modified2013-05-22 12:07:36
  • 3(array)
    • Application(array)
      • id1024
      • user_id695
      • trial_status_id7
      • abstract_of_study<p>\n In line with WHO recommendations, Kenya conducts Therapeutic Efficacy Studies (TES) for 1^st and 2^nd line antimalarial medicines to monitor the threat of emergence and spread of artemisinin resistance. The objective of this four-arm prospective study is to assess the efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) used for the treatment of uncomplicated <em>P. falciparum </em>malaria among febrile patients aged between 6 and 59 months, with confirmed uncomplicated <em>P.Falciparum</em> monoinfection at one selected site in both Siaya and Bungoma Counties with a high out-patient attendance of malaria patients. At each site, at least 100 patients will be enrolled per drug (200 patients per site, 400 patients total) between July and December 2020. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate AL efficacy, and over a 42-day follow-up period to evaluate DHP efficacy. The study will determine proportion of patients with an adequate clinical and parasitological response (as indicators of efficacy). Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. The study will further determine the polymorphism of molecular markers of drug resistance and evasion of diagnostic testing. The results will enable Ministry of Health (MOH) make timely update of its malaria treatment and diagnostic policies and ensure global exchange of resistance data.</p>\n<p>\n  </p>\n
      • study_title<p>\n Efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the treatment of uncomplicated <em>Plasmodium</em> <em>falciparum</em> malaria in Siaya and Bungoma counties, Kenya.</p>\n
      • laymans_summary<p>\n Jhpiego through the Impact Malaria project funded by the US President’s Malaria Initiative (PMI) and in Collaboration with National Malaria Control Program-Ministry of Health, US Centers of Disease Control and Prevention (CDC), and the County Governments of Siaya and Bungoma plan to carry out a study to test how effective<em> Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) are still in the treatment of uncomplicated Plasmodium falciparum malaria in Siaya and Bungoma counties, Kenya</em>. The purpose of the study is to assess whether these two medicines are currently still effective in the treatment of malaria. The selected project sites will include  one health facility in Siaya and one in Bungoma County. The primary sample will consist of children aged between 6 months and 59 months who are eligible and whom have been confirmed to have uncomplicated malaria and their parents have consented for them to be in the study. Participants who meet the study inclusion criteria will be enrolled, treated on site and monitored.</p>\n<p>\n The results from the study will inform the Ministry of Health on effective current medicines used to treat malaria and if there is any growing resistance in Kenya.</p>\n
      • short_titleTherapeutic Efficacy Study
      • protocol_noECCT/21/06/15
      • version_no1
      • date_of_protocol01-03-2020
      • study_drugArtemether-Lumefantrine and Dihydroartemisinin-Piperaquine
      • disease_conditionUncomplicated malaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameArtemether-Lumefantrine and Dihydroartemisinin-Piperaquine
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameDihydroartemisinin-Piperaquine
      • comparator_registeredYes
      • comparator_countriesKenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressfredouma12@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Fredrick Ouma
      • declaration_date115-06-2021
      • declaration_principal_investigatorDr. Willis Akhwale
      • declaration_date215-06-2021
      • placebo_presentNo
      • study_objectives<ol style=\"list-style-type:upper-alpha;\">\n <li>\n General objective: To assess the therapeutic efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the treatment of uncomplicated <em>P. falciparum</em> malaria in Siaya and Bungoma counties, Kenya.</li>\n</ol>\n<p>\n (B) Specific objectives:</p>\n<ol>\n <li>\n To measure the clinical and parasitological efficacy of AL and DHP in patients aged between 6 months and 59 months, suffering from uncomplicated <em>P. falciparum </em>malaria by determining the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy;</li>\n <li>\n To differentiate recrudescence from new infection by polymerase chain reaction (PCR) analysis.</li>\n <li>\n To determine the polymorphism of molecular markers of drug resistance and evasion of diagnostic testing.</li>\n <li>\n To determine the blood concentration of AL</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Age between 6 months to 59 months</li>\n <li>\n Mono-infection with <em>p. Falciparum</em> confirmed by positive blood smear (i.e. No mixed infection)</li>\n <li>\n Parasitaemia of 1,000 – 100,000/µl asexual forms</li>\n <li>\n Presence of axillary temperature ≥ 37.5 °c or history of fever during the past 24 h</li>\n <li>\n Ability to swallow oral medication</li>\n <li>\n Haemoglobin >8.0 g/dl at admission</li>\n <li>\n Informed consent from a parent or guardian</li>\n <li>\n Parent/guardian agrees to bring the patient for the completion of AL and DHP doses and planned follow-up visits at day 7, 14, 21, and 28 plus days 35 and 42 for DHP follow up.</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ul>\n <li>\n General danger signs or signs of severe falciparum malaria according to the definitions of WHO (Appendix 2)</li>\n <li>\n Severe malnutrition according to WHO child growth standards (WHO, 2006), children with marasmus or oedematous malnutrition</li>\n <li>\n Mixed or mono-infection with another <em>Plasmodium</em> species detected by microscopy</li>\n <li>\n Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS)</li>\n <li>\n Regular medication, which may interfere with antimalarial pharmacokinetics</li>\n <li>\n History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)</li>\n <li>\n History of receiving any antimalarial treatment in the preceding 72 hours</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest WHO guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response, as defined in Appendix 5.</p>\n<p>\n As parasitological cure is the goal of antimalarial therapy, all study patients who show treatment failure will be given rescue treatment. Follow-up will continue until recovery. The outcome of the rescue treatment in these patients does not need to be recorded systematically for the purpose of the surveillance study.</p>\n<p>\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Kaluo Health Center: They have an inpatient maternity that has 200 deliveries in a month. Kaluo is headed by an experienced Nursing officer in-charge. There are 2 Clinical officer, 1 Lab officer, 1 pharmaceutical officer, 6 Nursing officer, 2 Peer educators, 1 Health and records officer, 1 Data clerk, 2 Adherence counselors and 2 HIV Testing counsellors among other CHVS and support staff.  Three community Units are attached to Kaluo Health centers. Kaluo receives adequate support from Alego Usonga Health Management Team especially the expert Microscopists. Their Infrastructure is adequate with their Lab having listed as a QI lab. The la conducts Tuberculosis, AFBs, Malaria, HB, O/C, Rapid Tests successfully among other biochemistry Tests. The staff undergo frequent trainings for Malaria.</p>\n<p>\n  </p>\n<p>\n Makhonge Health Center: The total case load between Oct 2018 – Sept 2019 was 7021 at the child Welfare clinic. Out of the 2480 suspected Malaria cases from the case load, 957 were positive (prevalence 38.5%). Makhonge is adequately stffed with an inpatient Maternity, Outpatient department, Lab and pharmacy. They have a facility Incharge, 2 Lab staff, 2 Clinical officer, 6 Nursing officers. A pharmacist is set to be posted as the medical supritendent in April 2021. The Lab has the capacity to conduct both Malaria Microscopy and Rapid tests.</p>\n<p>\n  </p>\n<p>\n Impact Malaria funded by PMI will be supporting the facilities with Key Equipment needed for the study as well as consumable items. These included Haemoque machines, Weighing scales, Thermometers, Microscopes, Cuvettes. </p>\n
      • other_details_explanation<p>\n Kenya has high malaria prevalence and endemicity</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationDecember 2021
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPatients on DHAP
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyDihydroartemisinin-Piperaquine
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site200
      • total_participants_worldwide400
      • 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_specifyChildren aged under 5 years (6 to 59 months)
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMaureen
      • investigator1_middle_nameMoraa
      • investigator1_family_nameMabiria
      • investigator1_qualificationMBChB
      • investigator1_professional_addressImpact Malaria Office - 14 Riverside, Arlington Block
      • investigator1_telephone+254722924636
      • investigator1_emailMaureen.Mabiria@jhpiego.org
      • organisations_transferred_Yes
      • number_participants400
      • notification
      • approval_date11-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-06-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-10-30 16:03:55
      • created2021-06-15 11:52:20
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
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        • id672
        • application_id1024
        • given_nameDr. Sarah-Blythe
        • middle_name
        • family_nameBallard
        • qualificationMD, MPH, PhD
        • professional_addressCDC
        • telephone+254722509168
        • emailzlo3@cdc.gov
        • created2021-06-15 11:55:00
        • modified2021-06-25 11:52:56
      • 1(array)
        • id673
        • application_id1024
        • given_nameDr. Willis
        • middle_name
        • family_nameAkhwale
        • qualificationMBChB, PhD
        • professional_addressALMA - Ministry of Health, Afya House
        • telephone+254721788913
        • emailwakhwale@alma2030.org
        • created2021-06-15 12:11:37
        • modified2021-06-25 11:52:56
      • 2(array)
        • id678
        • application_id1024
        • given_nameDr. Grace
        • middle_name
        • family_nameIkahu
        • qualificationMBChB, MPH
        • professional_addressAfya House, Nairobi
        • telephone+254721238791
        • emailmuchangigrace@gmail.com
        • created2021-06-17 20:51:59
        • modified2021-06-25 11:52:56
      • 3(array)
        • id679
        • application_id1024
        • given_nameDr. George
        • middle_name
        • family_nameGithuka
        • qualificationMBChB, MSc Field Epidemiology
        • professional_addressKNH Grounds, Nairobi
        • telephone+254722303481
        • emailgngithuka@yahoo.com
        • created2021-06-17 20:51:59
        • modified2021-06-25 11:52:56
      • 4(array)
        • id680
        • application_id1024
        • given_nameDr. Dickson
        • middle_nameMtungu
        • family_nameMwakangalu
        • qualificationMBChB, MPH
        • professional_addressImpact Malaria Office - 14 Riverside, Arlington Block
        • telephone+254722726184
        • emaildmtungu@gmail.com
        • created2021-06-17 20:51:59
        • modified2021-06-25 11:52:56
      • 5(array)
        • id681
        • application_id1024
        • given_nameDr. Elvis
        • middle_nameOmondi
        • family_nameOyugi
        • qualificationMBChB, MSc Field Epidemiology
        • professional_addressDNMP, KNH Grounds, Nairobi
        • telephone+254720483652
        • emaileloyugi@gmail.com
        • created2021-06-17 21:09:23
        • modified2021-06-25 11:52:56
      • 6(array)
        • id682
        • application_id1024
        • given_nameHellen
        • middle_name
        • family_nameGatakaa
        • qualificationBSc, MSc
        • professional_addressImpact Malaria Office - 14 Riverside, Arlington Block
        • telephone+254722865158
        • emailHellen.Gatakaa@jhpiego.org
        • created2021-06-17 21:09:23
        • modified2021-06-25 11:52:56
      • 7(array)
        • id683
        • application_id1024
        • given_nameRegina
        • middle_nameJepkosgei
        • family_nameKandie
        • qualificationBSc, MSc
        • professional_addressDNMP, KNH Grounds, Nairobi
        • telephone+254722841252
        • emailregkandie@gmail.com
        • created2021-06-17 21:09:23
        • modified2021-06-25 11:52:56
      • 8(array)
        • id684
        • application_id1024
        • given_nameDr. Fredrick
        • middle_nameOuma
        • family_nameOdhiambo
        • qualificationBPharm
        • professional_addressDNMP, KNH Grounds, Nairobi
        • telephone+254724976545
        • emailfredouma12@gmail.com
        • created2021-06-18 09:42:53
        • modified2021-06-25 11:52:56
    • SiteDetail(array)
      • 0(array)
        • id939
        • application_id1024
        • county_id39
        • site_nameMahonge Health Center
        • physical_addressMahonge Market, Kimilili Sub-county, Bungoma County
        • contact_details+254724514760
        • contact_personFacility In-charge
        • site_capacity(null)
        • misc(null)
        • created2021-06-15 11:55:00
        • modified2021-06-25 11:52:56
        • County(array)
          • id39
          • county_nameBung\'oma
          • created2012-06-15 10:26:45
          • modified2012-06-15 10:26:45
      • 1(array)
        • id946
        • application_id1024
        • county_id41
        • site_nameKaluo Health Center
        • physical_addressAlego-Usonga Sub-county, Siaya County
        • contact_details+254721579199
        • contact_personFacility in-charge
        • site_capacity(null)
        • misc(null)
        • created2021-06-17 20:19:33
        • modified2021-06-25 11:52:56
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
    • Sponsor(array)
      • 0(array)
        • id514
        • application_id1024
        • sponsorPresident Malaria Initiative (PMI)
        • sponsor_typeOthers
        • contact_personDr Sarah-Blythe Ballard
        • addressUS Embassy, United Nations Avenue, Nairobi - Kenya
        • telephone_number+254722509168
        • fax_number
        • cell_number+254722509168
        • email_addresszlo3@cdc.gov
        • created2021-06-15 11:55:00
        • modified2021-06-25 11:52:56
  • 4(array)
    • Application(array)
      • id278
      • user_id127
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background:</strong> According to KDHS 2008/9 the under 5-mortality rate has dropped from 115 per 1000 in 2003 KDHS, to 74 per 1000 in 2008, this represents an annual decline rate of 0.9%. Unless this rate is accelerated to at least 4.5%, Kenya is unlikely to meet MDG 4 by 2015. Integrated community case management (iCCM) coupled together with the administration of vitamin A supplements (VAS), is an important and viable option of reducing the mortality of children under the age of five <em>due to pneumonia, malaria and diarrhea</em>. Implementation of the iCCM in Kenya still remains inadequate. The main challenges to implementation include: inadequate training among the CHWs including little follow up post training in iCCM.</p>\n<p>\n <strong>The main objective</strong> is to determine whether trained, supervised and well supplied community health workers in hard to reach areas such as Homabay County can administer Vitamin A Supplements (VAS) and correctly perform iCCM and increase the proportion of children under five years receiving antibiotics for pneumonia, artementher-lumefantrine for malaria and zinc and oral rehydration therapy for diarrhoea by 20% compared to the baseline. On the other hand, despite efforts to improve vitamin A status among children through supplementation, advocacy for dietary diversification, bio fortification, industrial and home fortification of essential food commodities, VAD still remains a major public health problem in Kenya.  Studies have shown that about 42% of children under the age of five years in Sub Saharan Africa are at risk of VAD with Kenya at 76%. Achievement of Millennium Development Goal 4 of reducing under five mortality by two third by 2015, requires addressing or enhancing factors that contribute to child survival and development. Such factors include vitamin A supplementation and the integration of iCCM which will go a long way in reducing both maternal and child deaths.</p>\n<p>\n <strong>Methodology: </strong>The study will employ a pre and post design to compare iCCM and VAS health and process outcomes in Homabay County in Nyanza Province, Kenya during the intervention period, with those during a pre-intervention period. We will implement iCCM and VAS in a stepwise manner using a four-prong approach. The four prongs are 1) Sensitization of national, district, health center and community teams on iCCM and VAS 2) Training of the Community Health Extension Workers (CHEWS), CHWs and health care workers 3) Supervision and motivation of CHWs and 4) Commodity provision and accountability.</p>\n
      • study_title<p>\n Evaluating integrated community case management of pneumonia, malaria and diarrhoea among children under 5 years in Homabay County, Kenya.</p>\n
      • laymans_summary(null)
      • short_title Integrated community case management
      • protocol_noECCT/14/02/02
      • version_no1.4
      • date_of_protocol19-12-2013
      • study_drugAmoxicillin dispersible tablets [New formulation]
      • disease_conditionPneumonia
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameAmoxicillin dispersible tablets
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmaricianah@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_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
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      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
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      • applicant_registration_ctr(null)
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      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantPO BOX 614-40100 Kisumu, Tel No. +254 732 390 992 email: maricianah@yahoo.com
      • declaration_date123-02-2014
      • declaration_principal_investigatorDr. Onono Maricianah - Principal Investigator
      • declaration_date223-02-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n -Children aged 2months- 5 years<br />\n -Children suffering from Pneumonia, Diarrhoea and Malaria</p>\n
      • principal_exclusion_criteria<p>\n -Adults<br />\n -Children less than 2 months or over 5 years</p>\n<p>\n Children not suffering from Pneumonia, Diarrhoea and Malaria</p>\n
      • primary_end_points<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"732\">\n <tbody>\n <tr>\n <td style=\"width:160px;height:14px;\">\n <p>\n <strong>Primary outcome</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Proportion of children under 5 years with pneumonia who receive appropriate antibiotic treatment, compared to baseline</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:70px;\">\n <p>\n Proportion of CHWs who are able to rationally use antibiotics for treatment of pneumonia</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:83px;\">\n <p>\n Proportion of CHWs who appropriately account for supplied commodities</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to rationally use antimalarials</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to rationally use ORS and zinc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of mothers of children under 5 years who have symptoms of pneumonia or malaria who seek care from an appropriate provider</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of children aged 6 to 59 months who received VAS on a semi-annual basis.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to correctly administer VAS, defined as giving vitamin A supplementation to children aged 6 to 59 months on a semi-annual basis in the County</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n <strong>Secondary outcome</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of children treated for pneumonia who do not respond to treatment (experience treatment failure or relapse</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <br />\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
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      • staff_numbers<p>\n <strong>Dr. Onono Maricianah:</strong> M.B.Ch.B, MSc Clinical Research  Global Health Fellowship- Principal Investigator<br />\n <strong>Dr. Bukusi Elizabeth:</strong> MBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics) - Co-Investigator<br />\n <strong>Akama Eliud:</strong> BSc, Diploma Community Health Nursing - Co-Investigator<br />\n <strong>Owuor Kevin</strong>: MSc Research Methods, BSc. Statistics - Co-Investigator/Statistician</p>\n<p>\n  </p>\n<p>\n <strong>Strength of the research team and f</strong><strong>easibility of project completion: </strong>The researchers in the study are part of the Kenya Medical Research Institute (KEMRI). Kenya Medical Research Institute (KEMRI) is a state corporation responsible for carrying out health research in Kenya. Since it's inception, KEMRI has developed a critical mass of scientists and technical personnel, to enable it mount a competitive research infrastructure to rank as a leading centre of excellence in health research both in Africa as well as globally. The researchers on this project have experience working in Nyanza province, specifically the Mbita district, in collaboration with the Ministries of Health in implementing a large scale HIV/AIDS program – the Family AIDS Care and Education Services (FACES). KEMRI will build on its experience and institutional knowledge gained from working in Homabay County. In Homabay County, KEMRI has over the years: 1) spearheaded community mobilization and built community linkages in alignment with the Government of Kenya (GoK) Community Strategy; 2) achieved rapid decentralization of services in underserved communities through family-based comprehensive HIV service provision; 3) improved the health system capacity in Mbita through training, mentorship, ongoing supervision, lab and pharmacy support, and logistics development; 4) successfully conducted clinical research including Microbicide research in partnership with the International Partnership for Microbicides (IPM); 5) established partnerships with GoK and other local institutions working in the area; and 6) attracted philanthropic support to help fund projects in the area e.g. the construction of the Comprehensive Care Clinic in Sindo District hospital (Steinberg building) and the Kar Geno Centre, Suba.7) Established the Fishermen hotline that allows the fishermen to dial in to be referred to the nearest health facilities providing antiretroviral therapy and the  <em>Uliza!</em> clinicians’ hotline hosted by Safaricom. The <em>Uliza!</em> hotline provides an opportunity for care providers in the periphery to call and receive mentorship from qualified medical doctors in the care of HIV patients. 8) KEMRI has already developed a robotic text messaging software built upon the RapidSMS platform. The software has been extensively tested and refined for the automated delivery of pre-defined text messages at specified times and in any preferred language. The proposed will use a similar platform and benefit from the expertise acquired.</p>\n<p>\n <strong>Organization</strong></p>\n<p>\n The study will have a study coordinator (clinical) and assistant coordinator (nutritionist), monitoring and evaluation specialist and a programmer. There will also be 6 sub-county coordinators in charge of the 6 sub counties in Homabay county. Further the study will employ 21 diploma nurses to do follow up for all pneumonia cases seen in the community</p>\n<p>\n The study will utilise existing community units in Homabay county. The community units must be actively reporting on a monthly basis as per records from the county health management team.</p>\n<p>\n The study will have a hotline number +254734919191 in which every time a community health worker sees a suspected pneumonia case, s/he will send a message which will trigger systems for the case to be verified by a trained nurse</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n<p>\n The trial will be conducted in Kenya which is the host country of the applicant. Both WHO and UNICEF which are the sponsors have country offices in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n -Kenya Medical Research Institute Ethical Research Committee (KEMRI- ERC) 21st May 2013 Homabay County</p>\n<p>\n <br />\n -World Health Organisation Research Ethics Review Committee (WHO ERC) 6th January 2014 Homabay County</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration24 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
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      • single_site_member_stateYes
      • location_of_areaHomabay County
      • single_site_physical_addressLumumba Health Center, Agoi Street, PO BOX 614-40100 Kisumu-Kenya
      • single_site_contact_personDr. Maricianah Onono
      • single_site_telephone+254 732 390 992
      • multiple_sites_member_stateNo
      • multiple_countriesNo
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      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site888
      • total_participants_worldwideN/A
      • 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
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      • subjects_specifyChildren under 5years.
      • subjects_othersNo
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      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB MMed OBGYN MPH PHD
      • investigator1_professional_addressP.O Box 19464- 00202 ,Nairobi
      • investigator1_telephone+254 720 617 503
      • investigator1_emailebukusi@kemri.org
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      • number_participants888
      • notification<p>\n Dear Reviewers</p>\n<p>\n Rationale for Amoxicillin Dispersible Tablets (DTs) for Pneumonia in children</p>\n<p>\n The overall study is designed to determine whether CHWs can correctly diagnose pneumonia and treat them using Amoxicillin (suspension or dispersible tablets). As investigators we felt that given the evidence already existing for DTs that within the context of this implementation research project, we were best placed to use this amoxicillin DTs as they became available and measure outcomes at day 4 and 6 as per protocol. Currently the trained CHWs are already diagnosing and treating diarrhoea and malaria using Zinc DTs and Coartem DTs. They are also successfully diagnosing and treating pneumonia using Amoxicillin suspension in the community. A total of 192 children have been diagnosed and treated adn treatment confirmed by trained nurses. Given the success in use of DTs and in diagnosing and treating pneumonia, we believe now is the time to introduce the Amoxicllin DTs.</p>\n<p>\n Tablets and capsules can be difficult to swallow, and if perceived as bitter or unpleasant are often refused by childrenespecially when ill (WHO 2008). To overcome these problems, many paediatric medicines are given as liquid suspensions or syrups, with the taste masked by fruity or sweet flavourings. Effective drug administration in children requires formulations which allow for accurate weight or age- based dosing. With syrups and suspensions this is often done as full, half, or quarter spoonfuls, which has been shown to be inaccurate (Grießmann 2007). An alternative is to dispense measured syringes alongside medications. In a position statement on the preferred dosage forms for use in children, the World Health Organization now recommend that where available dispersible tablets should be chosen above suspensions due to advantages in dosing, storage, and transportation (WHO 2009). Dispersible amoxicillin has been identified as a priority medicine for the treatment of pneumonia; formulated as scored tablets of 250mg and 500mg, and packaged in blister packs of 10 (WHO/UNICEF 2010a ). Dispersible amoxicillin offers significant benefits over suspensions in terms of cost, product stability and ease of transport. Further, dispersable tablets have other advantages over the suspension such as 1) Dose accuracy: Dosing of liquids by spoon is unreliable. 2) Storage: Long shelf-life and no need for refridgeration 3) Transport: Less bulky and less susceptible to high temperatures. Paediatric dispersible tablets are already in use in Kenya for malaria, and well tolerated. Additionaly, based on WHO price lists, dispersible tablets could represent a cost saving compared to suspensions. (WHO/UNICEF 2010b).</p>\n<p>\n <strong>References</strong></p>\n<p>\n WHO 2008. The pathway to better medicines for children. 2008. Available at: http://www.who.int/childmedicines/Pathway.pdf</p>\n<p>\n Grießmann K, Breitkreutz J, Schubert-Zsilavecz et al. Dosing accuracy of measuring devices provided with antibiotic  oral suspensions. <em>Paediatric and Perinatal Drug Therapy</em><em>. </em>2007; <strong>8: </strong>61-70.</p>\n<p>\n <em>WHO technical report series; 958</em><em>. </em><em>The selection and use of essential medicines: report of the WHO Expert Committee, March 2009</em>. Geneva, World Health Organization, 2009.</p>\n<p>\n WHO/UNICEF 2010a. Priority essential medicines for child survival. 2010. Available at: http://www.who.int/childmedicines/progress/Unicef_prioriry_meds_child_survival.pdf</p>\n<p>\n WHO/UNICEF 2010b. Sources and prices of selected medicines for children including therapeutic food, dietary vitamin and mineral supplementation. 2010. Second edition. Available at: http://www.who.int/medicines/publications/essentialmedicines/Sources_Prices2010.pdf</p>\n
      • approval_date21-05-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-02-2014
      • is_child0
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      • initial_date_submitted(null)
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      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n  </p>\n<h1>\n Operationalization of integrated community case management in Homabay County, Kenya</h1>\n<h1>\n Executive summary</h1>\n<p>\n In a Kenya Ministry of Health and WHO-supported exercise in 2011, Kenyan experts (academics, clinicians and policy-makers) generated and systematically scored research questions for maternal, newborn and child health interventions to reduce child mortality in Kenya using Child Health and Nutrition Research Initiative methodology. During this exerciseintegrated community case management (iCCM), which included pneumonia home case management was identified as a top priority for research in Kenya. To address this gap, in 2013, the Ministry of Health mandated the Kenya Medical Research Institute (KEMRI) with support from UNICEF and WHO to demonstrate the feasibility and effectiveness of training Community health workers (CHWs) and supplying them with Oral Rehydration Salts (ORS), zinc, rapid diagnostic tests (RDTs) for malaria, artemether-lumefantrin (AL) and amoxicillin to treat diarrhoea, malaria and pneumonia at the community level as envisaged in iCCM. This report describes the implementation strategies, processes and outcomes of an iCCM programme in Homabay County in western Kenya as part of large-scale countywide implementation. In addition, the report examines: i) concordance in identification and classification of lower chest indrawing between CHWs and nurses; ii) acceptability, adherence and clinical outcomes of Amoxicillin dispersible tablets versus oral suspension in treatment of children aged 2-59 months with pneumonia; iii)patient level costs of treating childhood pneumonia at home versus in the health facility; iv) quality of care provided by facility based health care workers vs. community health workers for pneumonia in sick children under 5 years; and v) the association between adherence and multiple drug prescription for pneumonia, malaria and diarrheal in children under five years of age by CHWs</p>\n<p>\n  </p>\n<p>\n <strong>Methods: </strong></p>\n<p>\n This was a prospective observational implementation research project. CHWs in Homabay County, Kenya were trained, equipped and supervised to implement iCCM for sick children aged 2-59 months. Implementation was conducted using a five-pronged approach which involved: i) sensitization of national, county, sub-county, health facility and community teams; ii) training of CHWs, community health extension workers and health care workers; iii) commodity provision and accountability; iv) supervision of CHWs; and v) monitoring and evaluation. Mobile phones were used to ascertain correct management of pneumonia by CHWs, monitoring and evaluation of service level statistics and commodity tracking.</p>\n<p>\n <strong>Key findings:</strong></p>\n<p>\n <strong>Service level statistics: </strong>A total of 2604 CHWs and 200 community health extension workers (CHEWs) from 242 community units received training in iCCM. Between October 2013 and March 2015, 170 079 children were assessed and classified by the CHWs. CHWs treated 11 693 pneumonia, 9869 malaria and 26 713 diarrhoea cases in the community, referred 8906 children to a health facility for immunization, and gave age-appropriate doses of vitamin A supplementation to 137 585 children. </p>\n<p>\n <strong>Concordance in identification and classification of lower chest indrawing pneumonia between CHWs and nurses:</strong>CHWs were able to identify, classify and treat lower chest in-drawing pneumonia in children aged 2-59 months with a five-day course of oral amoxicillin with low treatment failure rates in a real programme setting in Kenya. The concordance for classification of lower chest indrawing between CHWs and nurses was high (88.7% agreement) and the observed treatment failure rate was low (2.1%). The concordance for classification of fast breathing pneumonia between CHWs and nurses was high (97% agreement) with an inter-rater difference of only 2 breaths/count.  CHWs were more likely to misclassify lower chest indrawing in children with co-morbidities such as malaria and diarrhoea, those with moderate malnutrition or those whose caregivers delayed care seeking. This subset of children likely represents sicker children for whom extra care is needed in disease assessment and classification. </p>\n<p>\n <strong>Acceptability, adherence and clinical outcomes of Amoxicillin dispersible tablets:</strong>When compared to Amoxicillin oral suspension, Amoxicillin dispersible tablets had better treatment adherence among the sick children. Amoxicillin dispersible tables were also just as acceptable and as effective as the amoxicillin oral suspension in the treatment of pneumonia in children aged 2-59 months.</p>\n<p>\n <strong>Perceived quality of care provided by facility based health care workers vs. CHWs for pneumonia in sick children under 5 years: </strong>Caregivers rated the quality of CHW provided home-based management for childhood pneumonia to be higher than facility based health workers (FBHW) provided care.  We used the Primary Care Assessment Survey (PCAS), a patient-completed questionnaire that operationalizes formal definitions of primary care. The PCAS measures seven domains of care through 11 summary scales: accessibility (organizational, financial), continuity (longitudinal, visit-based), comprehensiveness (contextual knowledge of patient, preventive counseling), integration, clinical interaction (clinician-patient communication, thoroughness of physical examinations), interpersonal treatment, and trust.</p>\n<p>\n Caregivers rated CHWs higher in regards to ease of access (geographic and financial). This is likely because of both the spatial distribution of CHWs, as they live in the community and therefore are closer to clients, and the fact that CHWs don’t charge user fees for care or medications. CHWs were rated more highly than FBHWs in their ability to communicate with caregivers and instill trust. Patients answered positively when asked about the integrity, friendliness and support in decision-making by CHWs. Even in regards to clinical skills, the area in which FBHWs have a clear advantage, caregivers rated CHWs and FBHWs equally. One explanation could be that CHWs simply spend more time with the patients and are therefore able to perform a more thorough evaluation. In terms of overall satisfaction, CHWs were preferred to FBHWs when examining either a self-reported satisfaction score or a summary score that was calculated as the mean across all PCAS domains indicating acceptability</p>\n<p>\n <strong>Patient level costs of treating childhood pneumonia at home versus in the health facility. </strong>The estimated costs associated with treatment of a pneumonia episode in under-five children can be divided into direct and indirect out-of-pocket expenses incurred by the household for an episode of pneumonia.Direct medical costs are the actual amount paid by the households for consultation, investigations such as radiology, hospital admissions and medicines. Direct non-medical costs are incurred for transportation and meals for caregivers at the health facility. Indirect costs are the opportunity cost of caregiver time and fore gone wages during the time of seeking care for the child.The average total household cost of treatment of pneumonia was KSh. 194.36($2.04) and KSh 2201.64 ($23.18) for the caregivers that sort care from the CHW and health facility respectively. This is an 11-fold difference in cost of treatment. The cost of treatment of pneumonia has significant influence on subsequent health seeking behaviour as caregivers tend to subsequently seek care where it’s deemed cheaper for them. </p>\n<p>\n <strong>Effect of multiple drug prescription for pneumonia, malaria and diarrhoea on adherence in children under five years of age by CHWs: </strong>Among children classified as having pneumonia plus additional diarrhoea and or malaria, the treatment with combinations of anti-malarial, antibiotics and/ORS and zinc sulphate did not lower adherence compared to antibiotic alone. In addition, there was no difference in treatment failure in the two arms. </p>\n<p>\n  </p>\n<p>\n It is anticipated that with the evidence provided by this project, the Kenyan Ministry of health as well as the county health management teams will begin to adopt these practical solutions for iCCM regarding training, supplies and supervision.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Summary of recommendations:  </strong></p>\n<p>\n This large-scale implementation of iCCM in Homabay demonstrated practical approaches and models of providing services, linking community and health facility commodity management and strengthening the capacity of CHWs to manage common childhood illnesses in a community setting. The project established that when CHWs are trained, supervised and supported, they are able to have adequate knowledge, skills and competency to provide quality services including treatment of sick children. </p>\n<p>\n             The experience of this implementation project has important implications for expansion of iCCM in Kenya. We propose the following recommendations </p>\n<p style=\"margin-left:.25in;\">\n 1.    CHWs in this project demonstrated high competency rates and outranked facility based health care workers in terms of perceived quality of care and overall satisfaction. We therefore recommend that CHWs and iCCM be a key component of increasing access to treatment of childhood illnesses such as diarrhoea malaria and pneumonia to address child survival in Kenya </p>\n<p style=\"margin-left:.25in;\">\n 2.    Mechanisms of performance review and clinical accreditation of skills after basic training are needed in order to produce and maintain competency among CHWs; </p>\n<p style=\"margin-left:.25in;\">\n 3.    Availability of commodities to CHWs coupled with strong health facility-community linkages are crucial to success.</p>\n<p style=\"margin-left:.25in;\">\n 4.    Because CHWs experienced some challenge in classification of sicker children particularly those with moderate malnutrition, training curricula, needs to emphasize prompt identification and referral for all cases of moderate and severe malnutrition. CHWs should be able to identify and refer children with any danger sign and those with malnutrition. Additionally, caregivers need to be educated and motivated to seek appropriate care early</p>\n<p style=\"margin-left:.25in;\">\n 5.    Given the higher adherence rates and equivalence in effectiveness and acceptability, we recommend that Amoxicillin dispersible tablet be preferentially prescribed over the oral suspension for the treatment of pneumonia in children aged 2-59 months.</p>\n<p style=\"margin-left:.25in;\">\n 6.    Given that the household costs of iCCM of pneumonia were eleven times lower than facility based pneumonia treatment, we recommend the scale up of pneumonia treatment with oral amoxicillin at community level. Pneumonia home case management can significantly reduce household cost, improve access and better treatment outcomes to the underprivileged population, preventing many child deaths. It also has potential to decrease economic burden on the families besides decreasing pressure and cost on the already overburdened public health system.</p>\n
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        • given_nameMaricianah
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        • professional_addressP.O Box 614 Postal Code 40100, Kisumu-Kenya
        • telephone+254 732 390 992
        • emailmaricianah@yahoo.com
        • created2014-02-23 05:49:04
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        • contact_personDr. Ketema Aschenaki Bizuneh
        • addressUNICEF, Kenya Country Office, P.O. Box 44145-00100,
        • telephone_number254 (20) 762 2209
        • fax_number254 (20) 762 27 46
        • cell_number+254 719 390 115
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        • contact_personDr. Shamim Qazi
        • address20 Avenue Appia, Geneva 27, 1211 Switzerland
        • telephone_number(+41-22) 791-2547
        • fax_number(+41-22) 791-4853
        • cell_number(+41-22) 791-2547
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      • 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