Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT00330902
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2006-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C001205', 'term': 'fanasil, pyrimethamine drug combination'}, {'id': 'D011319', 'term': 'Primaquine'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-30', 'studyFirstSubmitDate': '2006-05-25', 'studyFirstSubmitQcDate': '2006-05-25', 'lastUpdatePostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P.falciparum parasitaemia detected by PCR on days 3,7 and 14.', 'timeFrame': '14 days from start of treatment'}], 'secondaryOutcomes': [{'measure': 'Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.', 'timeFrame': '14 days from start of treatment'}, {'measure': 'Packed Cell volume on days 7 and 14.', 'timeFrame': 'Over 14 days from start of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['malaria', 'subpatent parasitaemia', 'dry season', 'primaquine', 'Plasmodium falciparum infection detected by PCR'], 'conditions': ['Plasmodium Infections']}, 'referencesModule': {'references': [{'pmid': '18074034', 'type': 'DERIVED', 'citation': 'El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.'}]}, 'descriptionModule': {'briefSummary': 'In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.', 'detailedDescription': '104 individuals with low density Plasmodium falciparum infection detected by polymerase chain reaction (PCR) were randomized to receive sulfadoxine-pyrimethamine and three daily doses of artesunate (SP+AS) or SP+AS and a dose of primaquine (SP+AS+PQ), and were followed up for 14 days during the transmission-free season in Eastern Sudan. Subjects were visited on days 3, 7 and 14 after the start of treatment to record any adverse events and to detect P.falciparum using PCR. PCR positive samples were tested for gametocytes using RT-PCR. Packed cell volume was measured on days 7 and 14.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infection with P.falciparum detected by PCR\n\nExclusion Criteria:\n\n* pregnancy\n* severe anaemia\n* fever or other signs of illness\n* history of allergy to sulfa drugs\n* presence of other species of Plasmodium detected by microscopy'}, 'identificationModule': {'nctId': 'NCT00330902', 'briefTitle': 'Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan', 'orgStudyIdInfo': {'id': 'SGS64'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Sulfadoxine pyrimethamine plus three daily doses of artesunate', 'interventionNames': ['Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Sulfadoxine pyrimethamine plus artesunate plus primaquine', 'interventionNames': ['Drug: primaquine (PQ) plus SP+AS']}], 'interventions': [{'name': 'sulfadoxine-pyrimethamine (SP) plus artesunate (AS)', 'type': 'DRUG', 'description': 'sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)', 'armGroupLabels': ['1']}, {'name': 'primaquine (PQ) plus SP+AS', 'type': 'DRUG', 'description': 'single dose of primaquine on day 4', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Khartoum', 'country': 'Sudan', 'facility': 'Tropical Medicine Research Institute', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}], 'overallOfficials': [{'name': 'Badria B El Sayed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TMRI, Khartoum'}, {'name': 'Omer Z Baraka, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, University of Khartoum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tropical Medicine Research Institute', 'class': 'OTHER'}, {'name': 'World Health Organization', 'class': 'OTHER'}]}}}