Intermittent Preventive Treatment in Infant in Mali

Malaria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766662
• Other study ID #: 06-55
• Status: Completed
• Phase: N/A
• First received: October 3, 2008
• Last updated: October 3, 2008
• Start date: October 2006
• Est. completion date: December 2007

Study information

• Verified date: September 2008
• Source: University of Bamako
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 23 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Sulfadoxine pyrimethamine

Locations

Country	Name	City	State
Mali	Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako	Bamako

Sponsors (2)

Lead Sponsor	Collaborator
University of Bamako	UNICEF

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPI vaccines and other health interventions coverage		1 year	No
Primary	Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine		1 year	No