Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UR3/CCU018969-01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfadoxine-pyrimethamine | Drug | |||
| sulfadoxine-pyrimethamine plus artesunate | Drug | |||
| lumefantrine plus artemether | Drug | |||
| Sleeping under insecticide-treated bednet | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and parasitologic failure rate |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter B Bloland, DVM, MPVM | Centers for Disease Control and Prevention | Principal Investigator |
| Salim Abdulla, MD, PhD | Ifakara Health Research and Development Centre | Study Director |
| John R MacArthur, MD, MPH | Centers for Disease Control and Prevention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ngere Ngere Health Center | Ngerengere | Morogoro Rural | Tanzania | |||
| Ikwiriri Health Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ikwiriri |
| Rufiji |
| Tanzania |
| Lupiro Health Center | Lupiro | Ulanga | Tanzania |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C001205 | fanasil, pyrimethamine drug combination |
| D000077332 | Artesunate |
| D000078102 | Lumefantrine |
| D000077549 | Artemether |
| ID | Term |
|---|---|
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
Not provided
Not provided