Malaria (Uncomplicated)
Conditions
Keywords
malaria, sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artsunate, lumefantrine plus artemether, combination therapy
Brief 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
Detailed description
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
Interventions
DRUGSulfadoxine-pyrimethamine
DRUGlumefantrine plus artemether
BEHAVIORALSleeping under insecticide-treated bednet
Sponsors
United States Agency for International Development (USAID)
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and parasitologic failure rate | — |
Countries
Tanzania
Outcome results
None listed