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Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

NCT01636895 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2012-08-22

No results posted yet for this study

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.

Conditions

  • Pregnancy Complications Parasitic

Interventions

DRUG

Efficacy of suphladoxine/pyrimethamine as IPTp

3 tablets (single dose)given twice during pregnancy one month apart after quickening

DRUG

Efficacy of suphladoxine/pyrimethamine as IPTp

2 courses of 3 tablets of 500 mg N1-(5,6-dimethoxy-4-pyrimidinyl) sulfanilamide (sulfadoxine) and 25 mg 2,4-diamino-5-(p-chlorophenyl)-6-ethylpyrimidine (pyrimethamine)administered (at least 1 month apart) as DOTs to pregnant mother after quickening

Sponsors & Collaborators

  • Department for International Development, United Kingdom

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • University of Nigeria, Enugu Campus

    collaborator OTHER

  • Malaria Consortium, UK

    lead NETWORK

Principal Investigators

  • Daniel Chandramohan, PHD · London School of hygeine and tropical medicine

  • Elvis N Shu, PHD · College of Medicine, University of Nigeria , Enugu Campus

  • Ebenezer S Baba, MBBS, MPH · Malaria Consortium

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-11-30
Completion
2013-02-28

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636895 on ClinicalTrials.gov