Clinical trial
Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)
Name
Pro00077428
Description
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.
Trial arms
Trial start
2018-01-23
Estimated PCD
2020-12-16
Trial end
2020-12-16
Status
Completed
Phase
Early phase I
Treatment
Proguanil Oral Tablet
Dosing of daily proguanil will be approximately 3mg/kg/day,
Arms:
Proguanil Oral Tablet
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ)
Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
Arms:
Sulfadoxine/Pyrimethanine-Amodiaquine
Dihydroartemisinin-Piperaquine (DP)
3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
Arms:
Dihydroartemisinin-Piperaquine (DP)
Size
246
Primary endpoint
Incidence of Clinical Malaria Per Patient Year
12 months
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 (see Appendix J);
* Fridericia's corrected QT interval (QTcF) interval \> 450msec.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 246, 'type': 'ACTUAL'}}
Updated at
2024-04-23
1 organization
3 products
1 indication
Organization
Duke UniversityProduct
ProguanilIndication
Malaria