Project Details

A novel combination therapy for preventing febrile illnesses in children with sickle cell anemia

Abel Kakuru, MBChB, MSc, PhD

Summary

BACKGROUND: Malaria and bacterial infections are major causes of morbidity and mortality in children with sickle cell anemia (SCA). Chemoprevention with monthly sulfadoxine-pyrimethamine (SP) provides protection against non-malaria febrile illnesses but limited protection against malaria while monthly dihydroartemisinin-piperaquine (DP) provides better protection against malaria but no known protection against non-malaria febrile illnesses. GAP: The combination of DP+SP may prevent both malaria and non-malaria febrile illnesses in children with SCA, but it has not been studied. HYPOTHESIS: We will test the hypothesis that chemoprevention with monthly DP+SP is safe and more protective against all-cause febrile illnesses in children with SCA compared to monthly SP alone (the current standard of care in Uganda). METHODS: We will conduct a double-blind randomized controlled trial of monthly DP+SP vs SP alone in children with SCA in Tororo and Busia Districts, Uganda. We will enroll children with SCA, ages 2-10 years and randomly assign them to one of the two intervention arms at a ratio of 1:1 and follow them for one year for all their health care needs. Children randomized to SP alone will also receive DP placebo for blinding purposes. The primary outcome will be the incidence of all-cause febrile illnesses measured by passive surveillance. Secondary outcomes will include the incidence of febrile illnesses due to malaria, non-malarial febrile illnesses, hospitalizations, and adverse events. RESULTS: Pending. IMPACT: This study will help us identify safe and effective interventions for reducing morbidity due to febrile illnesses in children with SCA, which could potentially improve health outcomes in children with SCA living in malaria-endemic settings.