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Completed

NCT Number: NCT00766662

Intermittent Preventive Treatment in Infant in Mali

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

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

Up to 23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bamako, 0000, Mali

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sulfadoxine pyrimethamine

Drug

Primary outcomes

  1. EPI vaccines and other health interventions coverage

    Time frame: 1 year

  2. Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Bamako

Other

Collaborators

  • UNICEF

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 6, 2008
Registry last updated
Oct 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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