Evaluation of the Public Health Impact of Seasonal Intermittent Preventive Treatment (IPT) in Children in Senegal

Malaria Clinical Trial

Official title:

Evaluation of the Public Health Impact and Cost Effectiveness of Seasonal Intermittent Preventive Treatment in Children in Senegal

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00712374
• Other study ID #: PSP01
• Secondary ID: 40099
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 8, 2008
• Last updated: September 21, 2009
• Start date: September 2008
• Est. completion date: July 2012

Study information

• Verified date: September 2009
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministere de la sante
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100000
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 119 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• sulfadoxine-pyrimethamine plus amodiaquine
SP+AQ on three occasions during the malaria transmission season Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Cheikh Anta Diop University, Senegal, Institut de Recherche pour le Developpement, Senegal: Ministere de la Sante

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-causes mortality		2008-2010	Yes
Secondary	Incidence of malaria by passive case detection		2008-2010	No