Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-29 @ 12:04 PM
Study NCT ID:
NCT01213433
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amodiaquine+Artesunate for Uncomplicated Malaria Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C515299', 'term': 'amodiaquine, artesunate drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2010-09-30', 'studyFirstSubmitQcDate': '2010-10-01', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure at day 28', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uncomplicated Malaria']}, 'descriptionModule': {'briefSummary': 'This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and Females aged 6 months and above.\n* Body weight of 5 Kg and above.\n* RDT positive test.\n* Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.\n* Signed (or thumb-printed whenever patients are illiterate) informed consent.\n* Patients' willingness and ability to comply with the study protocol for the duration of the study.\n\nExclusion Criteria:\n\n* Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.\n* Known hypersensitivity to the study drugs.\n* Severe malaria.\n* Danger signs: not able to drink or breast-feed, vomiting (\\> twice in 24hours), recent history of convulsions (\\>1 in 24h), unconscious state, unable to sit or stand.\n* Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.\n* Severe malnutrition (defined as weight for height \\<70% of the median NCHS/WHO reference)."}, 'identificationModule': {'nctId': 'NCT01213433', 'acronym': 'ASAQ-MAL', 'briefTitle': 'Amodiaquine+Artesunate for Uncomplicated Malaria Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Muraz'}, 'officialTitle': 'Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso', 'orgStudyIdInfo': {'id': '016-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amodiaquine+Artesunate', 'interventionNames': ['Drug: Artesunate-Amodiaquine']}], 'interventions': [{'name': 'Artesunate-Amodiaquine', 'type': 'DRUG', 'description': 'Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008.It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)', 'armGroupLabels': ['Amodiaquine+Artesunate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01', 'city': 'Nanoro', 'state': 'Boulkiemdé', 'country': 'Burkina Faso', 'facility': 'CRUN', 'geoPoint': {'lat': 12.68662, 'lon': -2.19375}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Muraz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Tropical Medicine, Belgium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PharmD, PhD', 'investigatorFullName': 'Tinto Halidou', 'investigatorAffiliation': 'Centre Muraz'}}}}