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

NCT ID: NCT00372632

Last Updated: 2010-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1717 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

sulfadoxine-pyrimethamine

Group Type: EXPERIMENTAL

Sulfadoxine-Pyrimethamine

Intervention Type: DRUG

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

Interventions

Sulfadoxine-Pyrimethamine

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

fansidar

Eligibility Criteria

Inclusion Criteria

1. Pregnant women between 16-28 weeks of gestation;

2. Residence within the catchment's area of the health facility;

3. Willing to deliver at the health facility;

4. Willing to ; adhere to all requirements of the study;

5. Willing to provide written informed consent;

6. Aged 21 years and above

Exclusion Criteria

1. Severe anemia (Hb < 6 g/dL)

2. History of allergic reactions to sulfa drugs;

3. Taking other sulfa drugs as CTX;

4. History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);

5. History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;

6. Any significant illness that requires hospitalization;

7. Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;

8. Prior enrollment in the study or concurrent enrollment in another study

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Ministère de la Santé

Principal Investigators

Umberto D'Alessandro, MD,MSc, PHD

Role: STUDY_DIRECTOR

Institute of Tropical Medicine Antwerp

Locations

Programme Nationale de Controle de Paludisms

Kigali, , Rwanda

Countries

Rwanda

Other Identifiers

05 34 5 520

Identifier Type: -

Identifier Source: org_study_id