At a glance
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Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)
In Brief
A Phase 4 clinical trial evaluating Proguanil Oral Tablet, Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ), and 1 other intervention for Malaria,Falciparum. Completed, enrolled 246 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Dosing of daily proguanil will be approximately 3mg/kg/day,
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
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