Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

• Status: Unknown status
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study has two components: component A is a cohort study to determine the in vivo efficacy of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and component B is a cross sectional study of women delivering at the study hospitals to assess the effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context of increasing SP resistance. Results of component A and B studies will be used to model the relationship between the prevalence of molecular markers of SP resistance, in vivo efficacy to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for routine monitoring effectiveness of SP-IPTp as part of ANC surveillance.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Malaria Consortium, UK
• Collaborators: Department for International Development, United Kingdom; London School of Hygiene and Tropical Medicine; University of Nigeria, Enugu Campus
• Treatments: Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• gestational age 16-30 weeks

• Axillary temperature ,37.5 Degrees

• informed consent

Exclusion Criteria:

• gravida > 2

• previous inclusion in this study

• history of hypersensitivity to SP or components of SP

• Use of IPTp with SP during this pregnancy

• history of taking other antimalarials in the past month

• Known HIV infection