Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-04 @ 12:14 AM
Study NCT ID:
NCT00545935
Status:
COMPLETED
Last Update Posted:
2009-02-03
First Post:
2007-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso
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': 'C515299', 'term': 'amodiaquine, artesunate drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-10'}, 'lastUpdateSubmitDate': '2009-02-02', 'studyFirstSubmitDate': '2007-10-16', 'studyFirstSubmitQcDate': '2007-10-16', 'lastUpdatePostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of observed and self-reported non-serious adverse events over the 28 days observation period', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)', 'timeFrame': '28 days'}, {'measure': 'Early treatment failure (ETF) rate', 'timeFrame': '28 days'}, {'measure': 'Late clinical failure (LCF) rate at D14 and D28', 'timeFrame': '28 days'}, {'measure': 'Late parasitological failure (LPF) rate at D14 and D28', 'timeFrame': '28 days'}, {'measure': 'Fever clearance time', 'timeFrame': '28 days'}, {'measure': 'Parasite clearance time', 'timeFrame': '28 days'}, {'measure': 'Change in haematocrit after 2,14 and 28 days compared to baseline', 'timeFrame': '28 days'}, {'measure': 'MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose', 'timeFrame': '28 days'}]}, 'conditionsModule': {'conditions': ['Malaria']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0.5-5 year (6-59 months) old children\n* uncomplicated malaria caused by P. falciparum\n* asexual parasites ≥ 2000/µ and ≤ 200000/µ\n* axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours\n* Burkinabe nationality\n* informed consent\n\nExclusion Criteria:\n\n* complicated or severe malaria\n* any apparent significant disease\n* anaemia (haematocrit \\< 21%)\n* treated in the same trial before\n* modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine'}, 'identificationModule': {'nctId': 'NCT00545935', 'briefTitle': 'Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544', 'orgStudyIdInfo': {'id': 'MB-2007b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1-Methylenblue-Amodiaquine', 'interventionNames': ['Drug: Methylenblue-Amodiaquine (MB-AQ)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2-Methylenblue-Artesunate', 'interventionNames': ['Drug: Methylenblue-Artesunate (MB-AS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3-Artesunate-Amodiaquine', 'interventionNames': ['Drug: Artesunate-Amodiaquine (AS-AQ)']}], 'interventions': [{'name': 'Methylenblue-Amodiaquine (MB-AQ)', 'type': 'DRUG', 'description': 'For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ', 'armGroupLabels': ['1-Methylenblue-Amodiaquine']}, {'name': 'Methylenblue-Artesunate (MB-AS)', 'type': 'DRUG', 'description': '3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days', 'armGroupLabels': ['2-Methylenblue-Artesunate']}, {'name': 'Artesunate-Amodiaquine (AS-AQ)', 'type': 'DRUG', 'description': 'For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.', 'armGroupLabels': ['3-Artesunate-Amodiaquine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nouna', 'country': 'Burkina Faso', 'facility': 'Centre de Recherche en Sante de Nouna', 'geoPoint': {'lat': 12.72939, 'lon': -3.86305}}], 'overallOfficials': [{'name': 'Olaf Mueller, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}}}}