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| Sponsors and Collaborators: |
Gates Malaria Partnership IRD, Dakar, Senegal. Universite Cheikh Anta Diop, Dakar, Senegal Ministry of Health, Senegal |
|---|---|
| Information provided by: | Gates Malaria Partnership |
| ClinicalTrials.gov Identifier: | NCT00132548 |
Purpose
A recent study has shown that the administration of a single dose of sulfadoxine/pyrimethamine plus artesunate to Senegalese children on three occasions during a short malaria transmission season reduced the incidence of clinical attacks of malaria by 86%. However, use of this drug regimen led to the selection of parasites with molecular markers of resistance to pyrimethamine and sulfadoxine. Therefore, a trial of three alternative regimens has been undertaken to see if these are as effective and safe as the drug combination used in the initial study but less likely to select for drug resistance.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Drug: Pyrimethamine/sulfadoxine Drug: Amodiaquine Drug: Artesunate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Randomised Trial of the Efficacy and Safety of Four Drug Regimens When Used for Intermittent Preventive Treatment of Malaria in Senegalese Children |
| Estimated Enrollment: | 2200 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | December 2004 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Senegal | |
| Institut de recherche pour le developpement | |
| Dakar, Senegal, BP 1386 | |
| Principal Investigator: | Cheick Sokhna, PhD | IRD, Dakar, Senegal. |
More Information
| Study ID Numbers: | ITCRVF02 |
| Study First Received: | August 18, 2005 |
| Last Updated: | October 14, 2005 |
| ClinicalTrials.gov Identifier: | NCT00132548 History of Changes |
| Health Authority: | Senegal: Ministere de la sante |
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Malaria Children Intermittent preventive treatment Senegal |
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Folic Acid Artesunate Pyrimethamine Antimalarials Protozoan Infections Sulfadoxine-pyrimethamine |
Amodiaquine Anti-Infective Agents, Urinary Parasitic Diseases Malaria Folic Acid Antagonists Sulfadoxine |
|
Pyrimethamine Artesunate Protozoan Infections Anti-Infective Agents Amodiaquine Sulfadoxine-pyrimethamine Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Anti-Infective Agents, Urinary Enzyme Inhibitors |
Malaria Renal Agents Folic Acid Antagonists Sulfadoxine Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Parasitic Diseases Amebicides |
