Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00329134
Status:
COMPLETED
Last Update Posted:
2009-04-17
First Post:
2006-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-16', 'studyFirstSubmitDate': '2006-05-22', 'studyFirstSubmitQcDate': '2006-05-22', 'lastUpdatePostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clocktime when child has had no fever for minimal 48h (< 37,5°C)'}, {'measure': 'Parasitemy'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration of quinine at day 4 between first and second administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malaria']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'No pediatric formulations of quinine exist. Therefore, quinine tablets are broken into 2 or 4 parts, according to the body weight. Based on the body weight, 1/2 or 1/4 a tablet is administered to the child.\n\nAt this moment, quinine sulphate pellets are developed. These pellets enable an adequate dosing according to the body weight.\n\n56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malaria (falciparium malaria, uncomplicated)\n* Informed consent\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00329134', 'briefTitle': 'Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria', 'orgStudyIdInfo': {'id': '2006/177'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Administration of quinine sulphate taste-masked pellets', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Butare', 'country': 'Rwanda', 'facility': 'Centre Hospitalier De Butare', 'geoPoint': {'lat': -2.59667, 'lon': 29.73944}}], 'overallOfficials': [{'name': 'Luc Van Bortel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean Paul Remon', 'oldOrganization': 'University Ghent'}}}}