Clinical trial NCT00766662: Intermittent Preventive Treatment in Infant in Mali
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: Malaria
Intermittent Preventive Treatment
EPI vaccine coverage
Resistance of P. falciparum to Sulfadoxine- Pyrimethamine
Lead sponsor: University of Bamako
Sponsor class: OTHER
Collaborators: name: UNICEF
First posted: 2008-10-06
Sex: ALL
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: EPI vaccines and other health interventions coverage
timeFrame: 1 year
measure: Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako
Study officials:
affiliation: Faculty of Medicine, Pharmacy and Dentistry; University of Bamako
name: Alassane Dicko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Pharmacy and Dentistry; University of Bamako
name: Ogobara K Doumbo, MD
role: STUDY_DIRECTOR
References:
citation: Dicko A, Konare M, Traore D, Testa J, Salamon R, Doumbo O, Rogier C. The implementation of malaria intermittent preventive trialtreatment with sulphadoxine-pyrimethamine in infants reduced all-cause mortality in the district of Kolokani, Mali: results from a cluster randomized control. Malar J. 2012 Mar 16;11:73. doi: 10.1186/1475-2875-11-73.
citation: Dicko A, Toure SO, Traore M, Sagara I, Toure OB, Sissoko MS, Diallo AT, Rogier C, Salomon R, de Sousa A, Doumbo OK. Increase in EPI vaccines coverage after implementation of intermittent preventive treatment of malaria in infant with Sulfadoxine -pyrimethamine in the district of Kolokani, Mali: results from a cluster randomized control trial. BMC Public Health. 2011 Jul 18;11:573. doi: 10.1186/1471-2458-11-573.