Last Updated: 07/10/2019
Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria
Objectives
The aims of this study are:
- to determine the in vivo efficacy of SP to clear and prevent malaria parasitemia in asymptomatic pregnant women.
- to assess the effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context of increasing SP resistance.
ClinicalTrials.gov Identifier: NCT01636895
Study Phase: Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Methodology:
Study sites will include different levels of transmission and social factors affecting ANC attendance Damboa hospital in Borno state has a catchment area with pop of 231,573 with a semi-arid climate and where malaria is mesoendemic. The expected number of patients is 15-25 per week for new bookings Park Lane hospital serves a semiurban population. Malaria transmission is holoendemic and stable. 1400 women attend ANC services per month Women will receive SP-IPTp according to National guidelines and will be followed for 42 days to assess the therapeutic efficacy in parasitaemic women and to assess the ability to remain parasite free. PCR will be used to determine reinfection from recrudescence.
Jan 2011 — Feb 2013
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