Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-11 @ 11:03 AM
Study NCT ID:
NCT00140361
Status:
COMPLETED
Last Update Posted:
2012-09-11
First Post:
2005-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria
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': 'D000077332', 'term': 'Artesunate'}, {'id': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D000077549', 'term': 'Artemether'}], 'ancestors': [{'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-10', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and parasitologic failure rate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['malaria', 'sulfadoxine-pyrimethamine', 'sulfadoxine-pyrimethamine plus artsunate', 'lumefantrine plus artemether', 'combination therapy'], 'conditions': ['Malaria (Uncomplicated)']}, 'descriptionModule': {'briefSummary': 'This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children \\< 5 years in 3 sites in rural Tanzania.\n\nProtocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection', 'detailedDescription': 'This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children \\< 5 years in 3 sites in rural Tanzania.\n\nProtocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nChildren \\< 5 years of age (in one site, patients of all ages are eligible).\n\nDocumented fever (axillary temperature \\>= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition\n\nUnmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3\n\nPatients' or the patients' parent's or guardian's informed consent and willingness to participate in the study\n\nExclusion Criteria:\n\nAny evidence of severe malaria that would require hospitalization for treatment.\n\nReported allergy to any antimalarial drugs, including sulfa and artemisinin drugs.\n\nHistory of pregnancy or delayed menstrual period\n\nBreastfeeding a child less than 8 weeks of age"}, 'identificationModule': {'nctId': 'NCT00140361', 'briefTitle': 'Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children', 'orgStudyIdInfo': {'id': 'CDC-NCID-2577'}, 'secondaryIdInfos': [{'id': 'UR3/CCU018969-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Sulfadoxine-pyrimethamine', 'type': 'DRUG'}, {'name': 'sulfadoxine-pyrimethamine plus artesunate', 'type': 'DRUG'}, {'name': 'lumefantrine plus artemether', 'type': 'DRUG'}, {'name': 'Sleeping under insecticide-treated bednet', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ngerengere', 'state': 'Morogoro Rural', 'country': 'Tanzania', 'facility': 'Ngere Ngere Health Center', 'geoPoint': {'lat': -6.75, 'lon': 38.11667}}, {'city': 'Ikwiriri', 'state': 'Rufiji', 'country': 'Tanzania', 'facility': 'Ikwiriri Health Center', 'geoPoint': {'lat': -7.95618, 'lon': 38.97164}}, {'city': 'Lupiro', 'state': 'Ulanga', 'country': 'Tanzania', 'facility': 'Lupiro Health Center', 'geoPoint': {'lat': -8.38333, 'lon': 36.66667}}], 'overallOfficials': [{'name': 'Peter B Bloland, DVM, MPVM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}, {'name': 'Salim Abdulla, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ifakara Health Research and Development Centre'}, {'name': 'John R MacArthur, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}