Title
Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria
Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children
Phase
Phase 4Lead Sponsor
Centers for Disease Control and Prevention (CDC)Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Malaria (Uncomplicated)Intervention/Treatment
artesunate coartem sulfadoxine pyrimethamine lumefantrine ...Study Participants
390This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.
Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection
This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.
Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection
Inclusion Criteria: Children < 5 years of age (in one site, patients of all ages are eligible). Documented fever (axillary temperature >= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition Unmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3 Patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study Exclusion Criteria: Any evidence of severe malaria that would require hospitalization for treatment. Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs. History of pregnancy or delayed menstrual period Breastfeeding a child less than 8 weeks of age