Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria
NCT00140361 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390
Last updated 2012-09-11
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
Conditions
- Malaria (Uncomplicated)
Interventions
- DRUG
-
Sulfadoxine-pyrimethamine
- DRUG
-
sulfadoxine-pyrimethamine plus artesunate
- DRUG
-
lumefantrine plus artemether
- BEHAVIORAL
-
Sleeping under insecticide-treated bednet
Sponsors & Collaborators
-
United States Agency for International Development (USAID)
collaborator FED -
Centers for Disease Control and Prevention
lead FED
Principal Investigators
-
Peter B Bloland, DVM, MPVM · Centers for Disease Control and Prevention
-
Salim Abdulla, MD, PhD · Ifakara Health Research and Development Centre
-
John R MacArthur, MD, MPH · Centers for Disease Control and Prevention
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-01-31
- Primary Completion
- 2008-01-31
- Completion
- 2008-01-31
Countries
- Tanzania
Study Locations
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