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

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

Study Overview

• Status: Completed
• Conditions: Non HIV Infected Pregnant Women
• Intervention / Treatment: Drug: placebo; Drug: Sulfadoxine-Pyrimethamine

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.

• Study Type: Interventional
• Enrollment (Actual): 1717
• Phase: Phase 4

Contacts and Locations

Study Locations

• Rwanda
  • Kigali, Rwanda
    • Programme Nationale de Controle de Paludisms

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; The control group receives placebo similar in taste and appearance to to the experimental arm
Experimental: sulfadoxine-pyrimethamine	Drug: Sulfadoxine-Pyrimethamine; The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.; Other Names: fansidar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
malaria infection will be defined as the presence of asexual stage parasites on thick smears made with maternal side placental blood and Maternal peripheral blood	maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
LBW = birth weight <2,500 grams	at delivery
Premature delivery = delivery prior to 37 weeks gestation	at delivery
Spontaneous miscarriage = any spontaneous abortion before the end of gestation	at delivery
Stillbirth	at delivery
Cord blood parasitaemia = presence of asexual stage parasites in thick smears	at delivery
Neonatal death = infant death within the first 28 days of life	7days and 6 weeks after delivery
Maternal anemia = Hb <11.0 g/dL	at monthly visits between 16 weeks of gestation and delivery
Maternal severe anemia = Hb <6 g/dL	at monthly visits between 16 weeks of gestation and delivery
Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia	at monthly visits between 16 weeks of gestation and delivery
Severe maternal adverse reactions to SP = severe cutaneous reactions (e.g., erythema multiform, Stevens-Johnson syndrome, or toxic epidermal necrolysis)	at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Investigators: Study Director: Umberto D'Alessandro, MD,MSc, PHD, Institute of Tropical Medicine Antwerp

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: September 5, 2006
• First Submitted That Met QC Criteria: September 5, 2006
• First Posted (Estimate): September 7, 2006

Study Record Updates

• Last Update Posted (Estimate): September 14, 2010
• Last Update Submitted That Met QC Criteria: September 12, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Pregnancy malaria prevention
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Infective Agents, Urinary; Renal Agents; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
• Other Study ID Numbers: 05 34 5 520