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| Sponsors and Collaborators: |
Centers for Disease Control and Prevention US Agency for International Development |
|---|---|
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00140361 |
Purpose
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 Behavioral: Sleeping under insecticide-treated bednet |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children |
| Estimated Enrollment: | 2000 |
| Study Start Date: | January 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
Eligibility| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Peter B Bloland, DVM, MPVM | 770-488-7787 | pbb1@cdc.gov |
| Tanzania, Morogoro Rural | |
| Ngere Ngere Health Center | Active, not recruiting |
| Ngere Ngere, Morogoro Rural, Tanzania | |
| Tanzania, Rufiji | |
| Ikwiriri Health Center | Recruiting |
| Ikwiriri, Rufiji, Tanzania | |
| Contact: Salim Abdulla, MD, PhD 255 (0)22-213-2704 salim.abdulla@gmail.com | |
| Tanzania, Ulanga | |
| Lupiro Health Center | Recruiting |
| Lupiro, Ulanga, Tanzania | |
| Contact: Salim Abdulla, MD, PhD 255 (0)22-213-2704 salim.abdulla@gmail.com | |
| Principal Investigator: | Peter B Bloland, DVM, MPVM | Centers for Disease Control and Prevention |
| Study Director: | Salim Abdulla, MD, PhD | Ifakara Health Research and Development Centre |
| Study Director: | John R MacArthur, MD, MPH | Centers for Disease Control and Prevention |
More Information
| Study ID Numbers: | CDC-NCID-2577, UR3/CCU018969-01 |
| Study First Received: | August 30, 2005 |
| Last Updated: | August 30, 2005 |
| ClinicalTrials.gov Identifier: | NCT00140361 |
| Health Authority: | United States: Federal Government; Tanzania: National Institute for Medical Research |
|
malaria sulfadoxine-pyrimethamine sulfadoxine-pyrimethamine plus artsunate lumefantrine plus artemether combination therapy |
|
Pyrimethamine Artesunate Benflumetol Protozoan Infections Sulfadoxine-pyrimethamine Clotrimazole Miconazole Artemisinine |
Tioconazole Malaria Sulfadoxine Artemether Folic Acid Artemisinins Parasitic Diseases |
|
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antiplatyhelmintic Agents Coccidiosis Anthelmintics Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists |
Renal Agents Schistosomicides Pharmacologic Actions Antimalarials Antiparasitic Agents Antifungal Agents Therapeutic Uses Amebicides Coccidiostats |
