Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)

• Status: Completed
• Trial end date: 2020-12-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Amodiaquine; Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine; Proguanil; Sulfadoxine

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.