Back to resultsIntermittent Preventive Treatment in Infant in Mali
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Mali
Study Type
Interventional
Intervention
Sulfadoxine pyrimethamine
Sponsored by
About this trial
This is an interventional health services research trial for Malaria focused on measuring Malaria, Intermittent Preventive Treatment, EPI vaccine coverage, Resistance of P. falciparum to Sulfadoxine- Pyrimethamine
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
Sites / Locations
- Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako
Outcomes
Primary Outcome Measures
EPI vaccines and other health interventions coverage
Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine
Secondary Outcome Measures
Full Information
NCT ID
NCT00766662
First Posted
October 3, 2008
Last Updated
October 3, 2008
Sponsor
University of Bamako
Collaborators
UNICEF
1. Study Identification
Unique Protocol Identification Number
NCT00766662
Brief Title
Intermittent Preventive Treatment in Infant in Mali
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bamako
Collaborators
UNICEF
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, Intermittent Preventive Treatment, EPI vaccine coverage, Resistance of P. falciparum to Sulfadoxine- Pyrimethamine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine pyrimethamine
Primary Outcome Measure Information:
Title
EPI vaccines and other health interventions coverage
Time Frame
1 year
Title
Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine
Time Frame
1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alassane Dicko, MD
Organizational Affiliation
Faculty of Medicine, Pharmacy and Dentistry; University of Bamako
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ogobara K Doumbo, MD
Organizational Affiliation
Faculty of Medicine, Pharmacy and Dentistry; University of Bamako
Official's Role
Study Director
Facility Information:
Facility Name
Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako
City
Bamako
ZIP/Postal Code
0000
Country
Mali
12. IPD Sharing Statement
Citations:
PubMed Identifier
22423611
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.
Results Reference
derived
PubMed Identifier
21767403
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.
Results Reference
derived
Learn more about this trial
Intermittent Preventive Treatment in Infant in Mali
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