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Sponsors and Collaborators: |
London School of Hygiene and Tropical Medicine Senegal: Ministere de la Sante Institut de Recherche pour le Developpement Senegal: Universite Cheikh Anta Diop |
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Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00712374 |
In areas of seasonal malaria transmission the burden of severe disease and mortality due to malaria is mainly among children under 5 years of age. Intermittent preventive treatment (IPT) with antimalarial drugs given to all children once a month during the transmission season is a promising new strategy for malaria prevention. Studies in Senegal, Ghana, Mali and The Gambia have shown this approach can be highly effective. In Senegal, seasonal IPT with sulfadoxine-pyrimethamine (SP) and one dose of artesunate resulted in a 90% reduction in incidence of clinical malaria in a recent trial in Senegal (Cisse et al., Lancet 2006). The purpose of the present project is to determine the public health impact and cost effectiveness of this intervention when it is delivered through the routine health service to communities in rural areas in Senegal. Demographic surveillance will be set up in the rural population of three districts (Mbour, Bambey and Fatick) which comprises approximately 540,000 people, including 100,000 children under 5 yrs, and is served by 54 health posts, as an expansion of the area covered by the existing DSS of Niakhar. Information about births, deaths and migrations, household characteristics such as socioeconomic status, and vaccination status of children and their use of bednets, will be recorded in 6-monthly rounds of all households. In selected areas, deaths among children under 10 years will be investigated using verbal autopsies. Over four years from September 2008 - November 2011, seasonal IPT (three monthly administrations of SP (sulfalene-pyrimethamine) plus amodiaquine during the transmission season each year to children 3-59 months of age) will be introduced gradually, in a step-wedge design, by 9 health posts in 2008, by an additional 18 posts in 2009, and another 18 in 2010 and 9 in 2011. At the end of each transmission season, a cross-sectional survey of 2400 children under 5 yrs of age, in which finger prick blood samples will be taken, will be used to estimate the prevalence of molecular markers of drug resistance to Plasmodium falciparum, the prevalence of anaemia and the nutritional status of children. Malaria incidence will be monitored by passive surveillance through health posts, health centres, and hospitals. Cost effectiveness will be assessed.
Condition | Intervention | Phase |
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Malaria |
Drug: sulfalene-pyrimethamine plus amodiaquine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Evaluation of the Public Health Impact and Cost Effectiveness of Seasonal Intermittent Preventive Treatment in Children in Senegal |
Estimated Enrollment: | 100000 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Intervention: Experimental
Children 3-59 months old will receive a treatment dose of SP+AQ on three occasions during the malaria transmission season, delivered by the local health post
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Drug: sulfalene-pyrimethamine plus amodiaquine
SP+AQ on three occasions during the malaria transmission season Intermittent Preventive Treatment with sulfalene-pyrimethamine plus amodiaquine |
Ages Eligible for Study: | 3 Months to 59 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Oumar Gaye, PhD | Universite CHeikh Anta Diop |
Principal Investigator: | Badara Cisse, PhD | London School of Hygiene and Tropical Medicine |
Principal Investigator: | Cheikh Sokhna, PhD | IRD, Dakar |
Principal Investigator: | Oumar Faye, MD | Ministere de la Sante et de la Prevention |
Principal Investigator: | Paul Milligan, PhD | London School of Hygiene and Tropical Medicine |
Responsible Party: | Universite Cheikh Anta Diop ( Prof Oumar Gaye ) |
Study ID Numbers: | PSP01, 40099 |
Study First Received: | July 8, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00712374 History of Changes |
Health Authority: | Senegal: Ministere de la sante |
Malaria All causes mortality Cost effectiveness |
Pyrimethamine Protozoan Infections Anti-Infective Agents Amodiaquine Folate Malaria Anti-Infective Agents, Urinary |
Folic Acid Antagonists Folinic Acid Vitamin B9 Folic Acid Antimalarials Sulfalene Parasitic Diseases |
Pyrimethamine Protozoan Infections Anti-Infective Agents Amodiaquine Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Anti-Infective Agents, Urinary Enzyme Inhibitors |
Malaria Renal Agents Folic Acid Antagonists Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Sulfalene Parasitic Diseases |