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Sponsors and Collaborators: |
Gates Malaria Partnership Medical Research Council |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00376155 |
Antimalarial chemoprophylaxis can reduce morbidity and mortality from malaria in children. However, this approach to malaria control has not been implemented widely because of concerns over its possible effect on the development of resistance and natural immunity. Intermittent preventive treatment (IPT) may be able to achieve some of the beneficial effects of chemoprophylaxis without its drawbacks. Recently, it has been shown that IPT given to Senegalese children under the age of five years on three occasions during the malaria transmission season reduced the incidence of clinical malaria by approximately 90%. However, it is uncertain how this intervention can be most effectively delivered. Therefore, 26 Maternal and Child Health (MCH) trekking clinics in Upper River Division, south of the River Gambia, each with an average catchment population of 400-500 children under 5 years of age, will be randomly allocated to receive IPT from the MCH trekking team or from a IPT dispenser (village health worker, traditional birth attendant or a community mother based in a primary health care village). Treatment with a single dose of sulfadoxine /pyrimethamine (SP) plus three doses of amodiaquine will be given to all study subjects at monthly intervals on three occasions during the months of September, October and November. The primary end points will be the incidence of clinical attacks of malaria detected by passive case detection, and cost-effectiveness of the delivery methods. Important secondary endpoints will be the coverage and the equity of coverage of IPT in preventing malaria morbidity.
Condition | Intervention | Phase |
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Malaria |
Drug: sulfadoxine /pyrimethamine plus amodiaquine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Two Strategies for the Delivery of Intermittent Preventive Treatment in Children (IPTc) in an Area of Seasonal Malaria Transmission |
Enrollment: | 14000 |
Study Start Date: | May 2006 |
Study Completion Date: | February 2007 |
Ages Eligible for Study: | 3 Months to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
1. Previous adverse reaction to treatment with SP or amodiaquine. If this is unknown, then a history of allergic reaction to any drug.
Gambia | |
MRC Laboratories | |
Banjul, Gambia, PO Box 273 |
Principal Investigator: | Kalifa Bojang, MD | MRC Laboratories, The Gambia |
Study ID Numbers: | ITCRVG47, SCC990 |
Study First Received: | September 13, 2006 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00376155 |
Health Authority: | Gambia: MRC Ethics Committee |
malaria prevention intermittent drugs |
Folic Acid Pyrimethamine Protozoan Infections Amodiaquine |
Parasitic Diseases Malaria Sulfadoxine |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis |
Therapeutic Uses Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Folic Acid Antagonists Pharmacologic Actions |