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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Non HIV Infected Pregnant Women	Drug: Sulfadoxine-Pyrimethamine; Drug: placebo	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1717 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda
Study Start Date :	December 2005
Actual Primary Completion Date :	April 2008
Actual Study Completion Date :	April 2008

Arms and Interventions

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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 Name: fansidar

Outcome Measures

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Primary Outcome Measures :

1. 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 [ Time Frame: maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Rwanda
Programme Nationale de Controle de Paludisms
Kigali, Rwanda

Sponsors and Collaborators

Institute of Tropical Medicine, Belgium

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Programme Nationale Lutte integré contre le Paludism, Ministère de la Santé
ClinicalTrials.gov Identifier:	NCT00372632 History of Changes
Other Study ID Numbers:	05 34 5 520
First Posted:	September 7, 2006
Last Update Posted:	September 14, 2010
Last Verified:	September 2010

Keywords provided by Institute of Tropical Medicine, Belgium:

Pregnancy malaria prevention

Additional relevant MeSH terms:

Malaria; Protozoan Infections; Parasitic Diseases; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Antimalarials; Antiprotozoal Agents	Antiparasitic Agents; Anti-Infective Agents; Folic Acid Antagonists; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Urinary; Renal Agents