Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-09 @ 2:36 AM
Study NCT ID:
NCT00845533
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-15', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Uncomplicated Malaria']}, 'descriptionModule': {'briefSummary': 'This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this open-label trial in Burkina Faso. The target population includes residents, aged 6 months to 10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic sampling for DP will occur on selected follow-up days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Months', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Positive screening thick blood smear\n2. Fever (\\> 37.5ºC axillary) or history of fever in the previous 24 hours\n3. Age ≥ 6 months to 10 years\n4. Weight \\> 5 kg\n5. Absence of any history of serious side effects to study medications\n6. No evidence of a concomitant febrile illness in addition to malaria\n7. No history of antimalarial use in the previous two weeks\n8. P. falciparum mono-infection\n9. Parasite density 2000-200,000/ul\n10. Provision of informed consent and ability to participate in 42-day follow-up\n\nExclusion Criteria:\n\n1. Danger signs or evidence of severe malaria\n2. Hemoglobin levels \\< 5.0 gm/dL'}, 'identificationModule': {'nctId': 'NCT00845533', 'briefTitle': 'Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'orgStudyIdInfo': {'id': 'H40380-31179-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dihydroartemisinin-Piperaquine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sunil Parikh, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Philip J Rosenthal, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francsico'}, {'name': 'Jean-Bosco Ouedraogo, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Receherche en Sciences de la Sante Bobo-Dioulasso'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Holley-Cotec Pharmaceuticals Co., LTD.', 'class': 'UNKNOWN'}, {'name': 'Mahidol University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sunil Parikh', 'investigatorAffiliation': 'University of California, San Francisco'}}}}