Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-29 @ 2:02 AM
Study NCT ID:
NCT00540202
Status:
UNKNOWN
Last Update Posted:
2007-10-05
First Post:
2007-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}, {'id': 'D011803', 'term': 'Quinine'}], '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'}, {'id': 'D002930', 'term': 'Cinchona Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 302}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2008-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-10-04', 'studyFirstSubmitDate': '2007-10-04', 'studyFirstSubmitQcDate': '2007-10-04', 'lastUpdatePostDateStruct': {'date': '2007-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': '1. Fever clearance time assessed by self report. 2. Hemoglobin changes on day 0, 7, 14 and 28. 3. Safety profiles. 4. Adherence: measured by patient report and pill count on day 3 for the artemether-Lumefantrine group and day 7 for the quinine group.', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Effectiveness', 'Oral quinine', 'Coartem', 'Uncomplicated malaria', 'Children'], 'conditions': ['Uncomplicated Malaria']}, 'referencesModule': {'references': [{'pmid': '15569777', 'type': 'BACKGROUND', 'citation': 'Fogg C, Bajunirwe F, Piola P, Biraro S, Checchi F, Kiguli J, Namiiro P, Musabe J, Kyomugisha A, Guthmann JP. Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda. Am J Trop Med Hyg. 2004 Nov;71(5):525-30.'}, {'pmid': '10770766', 'type': 'BACKGROUND', 'citation': 'de Vries PJ, Bich NN, Van Thien H, Hung LN, Anh TK, Kager PA, Heisterkamp SH. Combinations of artemisinin and quinine for uncomplicated falciparum malaria: efficacy and pharmacodynamics. Antimicrob Agents Chemother. 2000 May;44(5):1302-8. doi: 10.1128/AAC.44.5.1302-1308.2000.'}, {'pmid': '19622553', 'type': 'DERIVED', 'citation': "Achan J, Tibenderana JK, Kyabayinze D, Wabwire Mangen F, Kamya MR, Dorsey G, D'Alessandro U, Rosenthal PJ, Talisuna AO. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial. BMJ. 2009 Jul 21;339:b2763. doi: 10.1136/bmj.b2763."}]}, 'descriptionModule': {'briefSummary': 'We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.', 'detailedDescription': 'This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged between 6 and 59 months of age seen at the assessment centre during the study period\n2. With fever defined as axillary temperature ≥37.5 °C or history of fever in the past 24 h\n3. With a microscopically confirmed monoinfection of Plasmodium falciparum\n4. Able to tolerate oral therapy,\n5. Whose parents/guardians have provided written informed consent.\n\nExclusion Criteria:\n\n1. Children with a history of allergy to quinine, artemether-Lumefantrine or milk.\n2. Evidence of severe malaria.\n3. Residence at more than 20km from the health clinic.\n4. Evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness'}, 'identificationModule': {'nctId': 'NCT00540202', 'acronym': 'QALE', 'briefTitle': 'Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children', 'orgStudyIdInfo': {'id': 'QALE07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.Oral quinine', 'description': 'Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days', 'interventionNames': ['Drug: Oral quinine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Coartem', 'description': 'Tablets', 'interventionNames': ['Drug: artemether-lumefantrine']}], 'interventions': [{'name': 'artemether-lumefantrine', 'type': 'DRUG', 'otherNames': ['Coartem'], 'description': 'Tablets taken twice daily for 3 days according to weight based guidelines.', 'armGroupLabels': ['2. Coartem']}, {'name': 'Oral quinine', 'type': 'DRUG', 'description': 'Quinine tablets given at 10mg/kg 8 hourly for 7 days', 'armGroupLabels': ['1.Oral quinine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '256', 'city': 'Kampala', 'state': 'Central Region', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Jane Achan, MMed', 'role': 'CONTACT', 'email': 'achanj@yahoo.co.uk', 'phone': '+256-772-410183'}, {'name': 'Catherine Maiteki, MD', 'role': 'CONTACT', 'email': 'cmaiteki@yahoo.com', 'phone': '+256-712-840449'}, {'name': 'Moses Kamya, MMed', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mulago National Referral Hospital', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'centralContacts': [{'name': 'Jane Achan, MMed', 'role': 'CONTACT', 'email': 'achanj@yahoo.co.uk', 'phone': '+256-772-410183'}, {'name': 'Daniel Kyabayinze, MSc', 'role': 'CONTACT', 'email': 'd.kyabayinze@malariaconsortium.org', 'phone': '+256-772-744066'}], 'overallOfficials': [{'name': 'Ambrose O Talisuna, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Uganda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Uganda', 'class': 'OTHER_GOV'}, {'name': 'Uganda Malaria Surveillance Project', 'class': 'OTHER'}]}}}