Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 9:11 PM
Study NCT ID:
NCT00454961
Status:
COMPLETED
Last Update Posted:
2007-10-25
First Post:
2007-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D016778', 'term': 'Malaria, Falciparum'}], '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': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}], 'ancestors': [{'id': 'D000077549', 'term': 'Artemether'}, {'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': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'lastUpdateSubmitDate': '2007-10-24', 'studyFirstSubmitDate': '2007-03-30', 'studyFirstSubmitQcDate': '2007-03-30', 'lastUpdatePostDateStruct': {'date': '2007-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine'}, {'measure': 'during 42 days follow-up.'}]}, 'conditionsModule': {'keywords': ['Malaria', 'Plasmodium falciparum', 'artemether-lumefantrine', 'effectiveness'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '21410954', 'type': 'DERIVED', 'citation': 'Ngasala BE, Malmberg M, Carlsson AM, Ferreira PE, Petzold MG, Blessborn D, Bergqvist Y, Gil JP, Premji Z, Martensson A. Effectiveness of artemether-lumefantrine provided by community health workers in under-five children with uncomplicated malaria in rural Tanzania: an open label prospective study. Malar J. 2011 Mar 16;10:64. doi: 10.1186/1475-2875-10-64.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (Coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of 42 days. The hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% PCR-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged \\<5 years\n2. Weight \\>5 kg\n3. Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL\n4. Having a history of fever in the preceding 24 h\n5. Able to ingest tablets orally\n6. Willing and able to attend stipulated follow-up visits\n7. With written informed consent from parent/guardian for children to participate in the trial.\n\nExclusion Criteria:\n\nPresenting with any of the following "danger signs of severe malaria":\n\n1. Convulsions (\\>1 episode within previous 24 hours)\n2. Lethargic/unconscious'}, 'identificationModule': {'nctId': 'NCT00454961', 'acronym': 'C3', 'briefTitle': 'Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Effectiveness of Artemether-Lumefantrine Treatment Provided by Community Health Worker Against Uncomplicated Malaria in Children Under 5 Years of Age in Tanzania', 'orgStudyIdInfo': {'id': 'CCC-2007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'artemether-lumefantrine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kibaha', 'country': 'Tanzania', 'facility': 'Kibaha District', 'geoPoint': {'lat': -6.76667, 'lon': 38.91667}}], 'overallOfficials': [{'name': 'Anders Björkman, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}}}}