Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborator: United States Agency for International Development (USAID)
• Treatments: Artemether; Artesunate; Fanasil, pyrimethamine drug combination; Lumefantrine; Pyrimethamine; Sulfadoxine

Criteria

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