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Sponsors and Collaborators: |
Gates Malaria Partnership IRD, Dakar, Senegal. IRD, Montpellier, France. Universite Cheikh Anta Diop, Dakar, Senegal Ministry of Health, Senegal |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00132561 |
In countries of the Sahel and sub-Sahel, malaria transmission is highly seasonal with nearly all infections occurring during a few months of the year. However, mortality and morbidity from malaria may be high during this period, especially in young children who are the group most at risk.
Intermittent preventative treatment (IPT) is a new approach to the prevention of malaria in this situation. IPT involves the administration of an anti-malarial to children at risk for malaria at fixed times, even if they are not infected. To investigate how effective this approach might be in Senegal, a trial has been undertaken in which 1136 children aged 6 weeks to 59 months were given a single dose of sulfadoxine pyrimethamine and artesunate on three occasions during a three-month rainy season and the incidence of clinical malaria in these children was compared with that in a group of children who received placebo. Additional observations were made on the incidence of side effects in children in the two groups and on the impact of IPT in children (IPTc) on markers of drug resistance in children whose blood films were positive for Plasmodium falciparum.
Condition | Intervention | Phase |
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Malaria |
Drug: Sulfadoxine/pyrimethamine and artesunate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Double-Blind, Randomised, Placebo-Controlled Trial to Measure the Potential of Intermittent Treatment With Artesunate Plus Sulphadoxine/Pyrimethamine (SP) to Reduce the Malaria Burden in Sub-Saharan Africa |
Estimated Enrollment: | 1200 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | December 2003 |
Ages Eligible for Study: | 6 Weeks to 59 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Senegal | |
Institut de recherche pour le developpement | |
Dakar, Senegal, BP 1386 |
Principal Investigator: | Badara Cisse, MD | IRD, Dakar, Senegal. |
Study ID Numbers: | ITCR 5094 |
Study First Received: | August 18, 2005 |
Last Updated: | May 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00132561 |
Health Authority: | Senegal: Ministere de la sante |
Folic Acid Artesunate Pyrimethamine Protozoan Infections |
Parasitic Diseases Malaria Sulfadoxine |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists |
Renal Agents Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Amebicides |