Intermittent Preventive Treatment in Infant in Mali

Not Applicable

Completed

• Conditions: Malaria

• Registration Number: NCT00766662
• Lead Sponsor: University of Bamako

Brief Summary

Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were

* to develop an implementation model for IPTi in the health care system in Mali

* to assess its impact on the EPI vaccines and other health interventions coverage

* and on molecular makers of resistance to SP

Detailed Description

The study was implemented in districts of the region of Koulikoro; the district of Koulikoro and the district of Kolokani. The whole district of Koulikoro was covered by the intervention while in Kolokani, the 22 health areas (sub districts) were randomized in 1:1 ratio with the intervention in 11 health areas and the other 11 serving as control for the assessment of the impact of IPTi implementation on EPI vaccines and other health interventions coverage as well as its impact on the resistance to SP. The implementation consisted of administration of ½ tablet of Sulfadoxine -Pyrimethamine with EPI vaccines (DTP2, DTP3 and Measles vaccine) from December 2006 to December 2007.

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-09
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Last Update Submitted: 2008-10-03
• Study First Posted: 2008-10-06
• Last Update Posted: 2008-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Resident of Kolokani, Mali
• Age less than 24 months

Exclusion Criteria

• Not Resident of Kolokani
• Age of 24 months or above

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
EPI vaccines and other health interventions coverage	1 year
Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine	1 year

Trial Locations

Locations (1)

Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako; 🇲🇱 Bamako, Mali