Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707002371165 Date of Approval: 22/06/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa
Official scientific title Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa
Brief summary describing the background and objectives of the trial This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three malaria chemoprevention regimens, and follow participants monthly for 12 months in order to record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the efficacy of each regimen to prevent malaria and SCA morbidity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EPiTOMISE
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/10/2017
Actual trial start date
Anticipated date of last follow up 01/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 246
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R01HL134211 NIH/NHLBI
NCT03178643 clinicaltrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Proguanil Daily 12 months Prophylaxis 82 Active-Treatment of Control Group
Experimental Group Sulfadoxine-pyrimethamine / amodiaquine Monthly 12 months Prophylaxis 82
Experimental Group Dihydroartemisinin - piperaquine Monthly 12 months Prophylaxis 82
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age greater than 12 months and less than 10 years at enrollment; Current attendance at or willingness to attend the study SCA clinic at HBCH; Residence in either Homa Bay County or the Rongo or Awendo sub-counties of Migori County; Confirmed hemoglobin genotype of HbSS by electrophoresis, HPLC, or PCR; No immediate, apparent, or reported plans to relocate residence from Homa Bay County or the Rongo or Awendo sub-counties of Migori County in the next 2 years; Ability to take oral medication and be willing to adhere to the medication regimen or caregiver willingness to give the medical regimen as prescribed; Ability and willingness of parent or legally authorized representative (LAR) to give informed consent; Assent of child in those > 7 years. Taking routine antimalarial prophylaxis for another indication (including co-trimoxazole for HIV infection); Temperature of ¿ 37.5C at screening or history of objective or subjective fever in the preceding 24 hours during screening; Known allergy or sensitivity to sulfadoxine, pyrimethamine, amodiaquine, proguanil, dihydroartemisinin, piperaquine, artemether, lumefantrine, pencillin (if under 5 years old), or derivatives of these compounds; Known chronic medical condition other than SCA (i.e. malignancy, HIV) requiring frequent medical attention; Currently participating in another clinical research study, or having participated in one in the prior 30 days; Living in the same household as a previously-enrolled study participant; Chronic use of medications known to prolong the QT interval in children; Fridericia's corrected QT interval (QTcF) interval > 450msec. 1 Year(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/05/2017 Duke University IRB
Ethics Committee Address
Street address City Postal code Country
2424 Erwin Rd Ste 405 Durham NC 27710 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/06/2017 Moi University IREC
Ethics Committee Address
Street address City Postal code Country
Academic Highway Eldoret Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome RDT-positive P falciparum malaria All over 12 months
Secondary Outcome Sickle-cell pain crises All over 12 months
Secondary Outcome Severe malaria All over 12 months
Secondary Outcome All-cause hospitalizations All over 12 months
Secondary Outcome Packed red blood cell transfusions All over 12 months
Secondary Outcome Acute chest syndrome All over 12 months
Secondary Outcome All-cause death All over 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Homa Bay County Hospital P.O Box 52 Homa Bay 40300 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
NHLBI Building 31, Room 5A52 Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Duke Clinical Research Institute 2400 Pratt Street Durham,NC 27705 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Moi University Academic Highway Eldoret 30100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Steve Taylor steve.taylor@duke.edu 9196845815 Box 102359 DUMC
City Postal code Country Position/Affiliation
Durham 27710 United States of America Assistant Professor, Duke University Medical Center
Role Name Email Phone Street address
Public Enquiries Sheila Clapp sheila.clapp@duke.edu 9196848111 PO Box 17969
City Postal code Country Position/Affiliation
DURHAM 27705 United States of America Project Lead, Duke Clinical Research Institute
Role Name Email Phone Street address
Scientific Enquiries Steve Taylor steve.taylor@duke.edu 9196845815 Box 102359 DUMC
City Postal code Country Position/Affiliation
Durham 27710 United States of America Assistant Professor, Duke University Medical Center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information