Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT00372632
Status:
COMPLETED
Last Update Posted:
2010-09-14
First Post:
2006-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C001205', 'term': 'fanasil, pyrimethamine drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1717}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-12', 'studyFirstSubmitDate': '2006-09-05', 'studyFirstSubmitQcDate': '2006-09-05', 'lastUpdatePostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery'}], 'secondaryOutcomes': [{'measure': 'LBW = birth weight <2,500 grams', 'timeFrame': 'at delivery'}, {'measure': 'Premature delivery = delivery prior to 37 weeks gestation', 'timeFrame': 'at delivery'}, {'measure': 'Spontaneous miscarriage = any spontaneous abortion before the end of gestation', 'timeFrame': 'at delivery'}, {'measure': 'Stillbirth', 'timeFrame': 'at delivery'}, {'measure': 'Cord blood parasitaemia = presence of asexual stage parasites in thick smears', 'timeFrame': 'at delivery'}, {'measure': 'Neonatal death = infant death within the first 28 days of life', 'timeFrame': '7days and 6 weeks after delivery'}, {'measure': 'Maternal anemia = Hb <11.0 g/dL', 'timeFrame': 'at monthly visits between 16 weeks of gestation and delivery'}, {'measure': 'Maternal severe anemia = Hb <6 g/dL', 'timeFrame': 'at monthly visits between 16 weeks of gestation and delivery'}, {'measure': 'Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia', 'timeFrame': 'at monthly visits between 16 weeks of gestation and delivery'}, {'measure': 'Severe maternal adverse reactions to SP = severe cutaneous reactions (e.g., erythema multiform, Stevens-Johnson syndrome, or toxic epidermal necrolysis)', 'timeFrame': 'at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy malaria prevention'], 'conditions': ['Non HIV Infected Pregnant Women']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pregnant women between 16-28 weeks of gestation;\n2. Residence within the catchment's area of the health facility;\n3. Willing to deliver at the health facility;\n4. Willing to ; adhere to all requirements of the study;\n5. Willing to provide written informed consent;\n6. Aged 21 years and above\n\nExclusion Criteria:\n\n1. Severe anemia (Hb \\< 6 g/dL)\n2. History of allergic reactions to sulfa drugs;\n3. Taking other sulfa drugs as CTX;\n4. History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);\n5. 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;\n6. Any significant illness that requires hospitalization;\n7. Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;\n8. Prior enrollment in the study or concurrent enrollment in another study"}, 'identificationModule': {'nctId': 'NCT00372632', 'briefTitle': 'IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Tropical Medicine, Belgium'}, 'officialTitle': 'Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda', 'orgStudyIdInfo': {'id': '05 34 5 520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'sulfadoxine-pyrimethamine', 'interventionNames': ['Drug: Sulfadoxine-Pyrimethamine']}], 'interventions': [{'name': 'Sulfadoxine-Pyrimethamine', 'type': 'DRUG', 'otherNames': ['fansidar'], 'description': 'The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.', 'armGroupLabels': ['sulfadoxine-pyrimethamine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'The control group receives placebo similar in taste and appearance to to the experimental arm', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kigali', 'country': 'Rwanda', 'facility': 'Programme Nationale de Controle de Paludisms', 'geoPoint': {'lat': -1.94995, 'lon': 30.05885}}], 'overallOfficials': [{'name': "Umberto D'Alessandro, MD,MSc, PHD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Tropical Medicine Antwerp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Tropical Medicine, Belgium', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Programme Nationale Lutte integré contre le Paludism', 'oldOrganization': 'Ministère de la Santé'}}}}