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IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda

NCT00372632 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1717

Last updated 2010-09-14

No results posted yet for this study

Summary

The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment

Conditions

  • Non HIV Infected Pregnant Women

Interventions

DRUG

placebo

The control group receives placebo similar in taste and appearance to to the experimental arm

DRUG

Sulfadoxine-Pyrimethamine

The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Umberto D'Alessandro, MD,MSc, PHD · Institute of Tropical Medicine Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Rwanda

Study Locations

More Related Trials

Entities

Drugs

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 NCT00372632 on ClinicalTrials.gov