IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda - Full Text View

Purpose

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	Intervention	Phase
Non HIV Infected Pregnant Women	Drug: Sulfadoxine-Pyrimethamine Drug: placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

LBW = birth weight <2,500 grams [ Time Frame: at delivery ] [ Designated as safety issue: No ]
Premature delivery = delivery prior to 37 weeks gestation [ Time Frame: at delivery ] [ Designated as safety issue: No ]
Spontaneous miscarriage = any spontaneous abortion before the end of gestation [ Time Frame: at delivery ] [ Designated as safety issue: No ]
Stillbirth [ Time Frame: at delivery ] [ Designated as safety issue: No ]
Cord blood parasitaemia = presence of asexual stage parasites in thick smears [ Time Frame: at delivery ] [ Designated as safety issue: No ]
Neonatal death = infant death within the first 28 days of life [ Time Frame: 7days and 6 weeks after delivery ] [ Designated as safety issue: No ]
Maternal anemia = Hb <11.0 g/dL [ Time Frame: at monthly visits between 16 weeks of gestation and delivery ] [ Designated as safety issue: No ]
Maternal severe anemia = Hb <6 g/dL [ Time Frame: at monthly visits between 16 weeks of gestation and delivery ] [ Designated as safety issue: No ]
Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia [ Time Frame: at monthly visits between 16 weeks of gestation and delivery ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]


Enrollment:	1717
Study Start Date:	December 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Criteria

Inclusion Criteria:

Pregnant women between 16-28 weeks of gestation;
Residence within the catchment's area of the health facility;
Willing to deliver at the health facility;
Willing to ; adhere to all requirements of the study;
Willing to provide written informed consent;
Aged 21 years and above

Exclusion Criteria:

Severe anemia (Hb < 6 g/dL)
History of allergic reactions to sulfa drugs;
Taking other sulfa drugs as CTX;
History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);
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;
Any significant illness that requires hospitalization;
Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;
Prior enrollment in the study or concurrent enrollment in another study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372632

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


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
Study First Received:	September 5, 2006
Last Updated:	September 12, 2010
Health Authority:	Belgium: Institutional Review Board Rwanda: Ethics Committee

Keywords provided by Institute of Tropical Medicine, Belgium:


Pregnancy malaria prevention

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 29, 2016