Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

Phase 4

• Conditions: Pregnancy Complications Parasitic
• Interventions: Drug: Efficacy of suphladoxine/pyrimethamine as IPTp

• Registration Number: NCT01636895
• Lead Sponsor: Malaria Consortium, UK

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-22
• Primary Completion: 2012-11
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP-IPTp efficacy	Efficacy of suphladoxine/pyrimethamine as IPTp	Efficacy of suphladoxine/pyrimethamine as IPTp

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women	15 months	PCR corrected Adequate parasitological clearance by day 42

Secondary Outcome Measures

Name	Time	Method
To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women	15 months	PCR uncorrected parasitological clearance by day 42
To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women	15 months	Prevalence of molecular markers of SP resistance at enrolment

Trial Locations

Locations (1)

Damboa Hospital Borno state and Park Lane hospital Enugu state; 🇳🇬 Enugu,, borno State and Enugu state, Nigeria