Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-27 @ 6:27 AM
Study NCT ID:
NCT00386750
Status:
TERMINATED
Last Update Posted:
2012-04-27
First Post:
2006-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 265}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2006-10-11', 'studyFirstSubmitQcDate': '2006-10-11', 'lastUpdatePostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).'}], 'secondaryOutcomes': [{'measure': 'Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test)'}, {'measure': 'Changes in auditory function with a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test)'}, {'measure': 'Relationship between changes in auditory function and drug exposure.'}]}, 'conditionsModule': {'keywords': ['Malaria', 'hearing', 'co-artemether', 'auditory', 'Plasmodium falciparum', 'marsh fever', 'Plasmodium infections', 'remittent fever', 'paludism', 'artemether', 'artemisinins', 'benflumetol', 'lumefantrine'], 'conditions': ['Malaria', 'Falciparum']}, 'descriptionModule': {'briefSummary': 'THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.\n\nTo evaluate the effects of artemether/ lumefantrine on the auditory function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* 12 years of age or older\n* P. falciparum parasitemia between 50 and 100,000 parasites/μl\n* History of fever or presence of fever (temperature ≥ 37.5°C)\n\nExclusion Criteria\n\n* Signs/symptoms of severe/complicated malaria\n* Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months\n* History of any drug-related hearing impairment.\n* Abnormal hearing function at study entry\n* Exposure to sustained loud noises, by self-report, within the past 24 hours. -- Present ear problems\n\n(Other protocol-defined inclusion/exclusion criteria may apply.)'}, 'identificationModule': {'nctId': 'NCT00386750', 'briefTitle': 'Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Single-center Study of the Effects of Co-artemether, Atovaquone-proguanil, and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older.', 'orgStudyIdInfo': {'id': 'CCOA566A2412'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Artemether-lumefantrine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}