Evaluation of the Public Health Impact of Seasonal Intermittent Preventive Treatment (IPT) in Children in Senegal
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Purpose
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. Due to changes in the epidemiology of malaria in the study area, the upper age limit for inclusion was increased from 5 to 10 years old from September 2009.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Drug: sulfadoxine-pyrimethamine plus amodiaquine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of the Public Health Impact and Cost Effectiveness of Seasonal Intermittent Preventive Treatment in Children in Senegal |
- All-causes mortality [ Time Frame: 2008-2010 ] [ Designated as safety issue: Yes ]
- Incidence of malaria by passive case detection [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: Intervention
Children 3 months to 10 years old will receive a treatment dose of SP+AQ on three occasions during the malaria transmission season, delivered by the local health post
|
Drug: sulfadoxine-pyrimethamine plus amodiaquine
SP+AQ on three occasions during the malaria transmission season Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine |
Eligibility| Ages Eligible for Study: | 3 Months to 119 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 3-119 months at time of first administration of IPT in September
- Consent of mother or carer and the local community
Exclusion Criteria:
- History of allergy to SP or AQ
- Age < 3 months or >119 months at time of first administration of IPT in September
From 2009, the age for inclusion has been changed from 3-59 months to 3 months to 10 years of age.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Prof Oumar Gaye, Universite Cheikh Anta Diop |
| ClinicalTrials.gov Identifier: | NCT00712374 History of Changes |
| Other Study ID Numbers: | PSP01, 40099 |
| Study First Received: | July 8, 2008 |
| Last Updated: | September 21, 2009 |
| Health Authority: | Senegal: Ministere de la sante |
Keywords provided by London School of Hygiene and Tropical Medicine:
|
Malaria All causes mortality Cost effectiveness |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Amodiaquine Pyrimethamine Sulfadoxine Sulfadoxine-pyrimethamine Antimalarials Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on June 18, 2013