Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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
Full 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
Enrollment
Sex
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal