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Sponsors and Collaborators: |
University of Bamako World Health Organization |
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Information provided by: | University of Bamako |
ClinicalTrials.gov Identifier: | NCT00623155 |
Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.
Condition | Intervention |
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Malaria |
Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management |
Enrollment: | 262 |
Study Start Date: | July 2002 |
Study Completion Date: | January 2004 |
Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Control group
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2: Experimental
Test group
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Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine
Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.
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Ages Eligible for Study: | 6 Months to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Mali | |
Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako | |
Bamako, Mali |
Study Director: | Ogobara Doumbo, MD | University of Bamako |
Principal Investigator: | Alassane Dicko, MD | University of Bamako |
Responsible Party: | Faculty of Medicine, Pharmacy and Dentistry, University of Bamako ( Dr. Alassane Dicko ) |
Study ID Numbers: | A10828 |
Study First Received: | February 14, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00623155 History of Changes |
Health Authority: | Mali: Ministry of Health |
malaria intermittent preventive treatment season children |
Pyrimethamine Protozoan Infections Anti-Infective Agents Sulfadoxine-pyrimethamine Folate Malaria Anti-Infective Agents, Urinary |
Sulfadoxine Folic Acid Antagonists Folinic Acid Vitamin B9 Folic Acid Antimalarials Parasitic Diseases |
Pyrimethamine Protozoan Infections Anti-Infective Agents 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 |