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

Condition	Intervention	Phase
Malaria (Uncomplicated)	Drug: Sulfadoxine-pyrimethamine  Drug: sulfadoxine-pyrimethamine plus artesunate  Drug: lumefantrine plus artemether  Behavior: Sleeping under insecticide-treated bednet	Phase IV

Further Study Details: 

Primary Outcomes: Clinical and parasitologic failure rate
Expected Total Enrollment:  2000

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

Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00140361

Peter B Bloland, DVM, MPVM      770-488-7787    pbb1@cdc.gov

Tanzania, Morogoro Rural
      Ngere Ngere Health Center, Ngere Ngere,  Morogoro Rural,  Tanzania; No longer recruiting
Tanzania, Rufiji
      Ikwiriri Health Center, Ikwiriri,  Rufiji,  Tanzania; Recruiting
Tanzania, Ulanga
      Lupiro Health Center, Lupiro,  Ulanga,  Tanzania; Recruiting

Study chairs or principal investigators

Peter B Bloland, DVM, MPVM,  Principal Investigator,  Centers for Disease Control and Prevention   
Salim Abdulla, MD, PhD,  Study Director,  Ifakara Health Research and Development Centre   
John R MacArthur, MD, MPH,  Study Director,  Centers for Disease Control and Prevention   

Study ID Numbers:  CDC-NCID-2577; UR3/CCU018969-01
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00140361
Health Authority: United States: Federal Government; Tanzania: National Institute for Medical Research
ClinicalTrials.gov processed this record on 2005-09-06