NCT00372632

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

Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,717 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: Female
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

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. This will be a randomized blinded placebo controlled trial: women in the 16-28th week of gestation will be offered enrolment into the study and randomized to receive IPT/SP regimen or placebo once during the second and once in the third trimesters. The study will be conducted in Mashesha (estimated SP drug resistance 20%, 12% in 2000), Kicukiro (40% SP resistance) and Rukara (60% SP resistance). In each of these sites there are about 1000 deliveries per year. According to DHMT data, over 75% of pregnant women attend antenatal clinics, usually booking between 15 and 25 weeks of gestation. Based on this study we expect to find placental malaria prevalence over 50% in all sites.

Conditions

• Non HIV Infected Pregnant Women

Interventions

Type	Name	Description
DRUG	Sulfadoxine-Pyrimethamine	The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
DRUG	placebo	The control group receives placebo similar in taste and appearance to to the experimental arm

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-09-07
• Last updated: 2010-09-14

Locations

1 site across 1 country: Rwanda