Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-03 @ 2:17 AM
Study NCT ID:
NCT01743820
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2012-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase2a Primaquine Dose Escalation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Thailand']}, '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': 'D011319', 'term': 'Primaquine'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-16', 'studyFirstSubmitDate': '2012-11-26', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mosquito infectivity assessed through membrane feeding', 'timeFrame': '7 days', 'description': 'Baseline, Days 1, 2, 7'}], 'secondaryOutcomes': [{'measure': 'gametocyte prevalence and density', 'timeFrame': '28 days', 'description': 'Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28'}, {'measure': 'primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite', 'timeFrame': '24 hours', 'description': 'Hours 1, 2, 3, 4, 6, 8, 12, 24'}, {'measure': 'asexual parasite prevalence and density', 'timeFrame': '28 days', 'description': 'Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28'}, {'measure': 'safety measurements including hemoglobin and signs of hemolysis', 'timeFrame': '28 days', 'description': 'Baseline, Days 1, 2, 3, 7, 14, 28'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '21951597', 'type': 'BACKGROUND', 'citation': 'Gosling RD, Okell L, Mosha J, Chandramohan D. The role of antimalarial treatment in the elimination of malaria. Clin Microbiol Infect. 2011 Nov;17(11):1617-23. doi: 10.1111/j.1469-0691.2011.03660.x. Epub 2011 Sep 26.'}, {'pmid': '17254503', 'type': 'BACKGROUND', 'citation': 'Baird JK, Schwartz E, Hoffman SL. Prevention and treatment of vivax malaria. Curr Infect Dis Rep. 2007 Jan;9(1):39-46. doi: 10.1007/s11908-007-0021-4.'}, {'type': 'BACKGROUND', 'citation': 'WHO (2011) World Malaria Report 2011. Geneva: World Health Organization.'}, {'type': 'BACKGROUND', 'citation': 'WHO (2010) Guidelines for the treatment of malaria, Second edition. Geneva: World Health Organization'}, {'pmid': '18074034', 'type': 'BACKGROUND', 'citation': 'El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.'}, {'pmid': '20194698', 'type': 'BACKGROUND', 'citation': 'Shekalaghe SA, ter Braak R, Daou M, Kavishe R, van den Bijllaardt W, van den Bosch S, Koenderink JB, Luty AJ, Whitty CJ, Drakeley C, Sauerwein RW, Bousema T. In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (G6PD A-) individuals. Antimicrob Agents Chemother. 2010 May;54(5):1762-8. doi: 10.1128/AAC.01135-09. Epub 2010 Mar 1.'}, {'pmid': '26906747', 'type': 'DERIVED', 'citation': 'Dicko A, Brown JM, Diawara H, Baber I, Mahamar A, Soumare HM, Sanogo K, Koita F, Keita S, Traore SF, Chen I, Poirot E, Hwang J, McCulloch C, Lanke K, Pett H, Niemi M, Nosten F, Bousema T, Gosling R. Primaquine to reduce transmission of Plasmodium falciparum malaria in Mali: a single-blind, dose-ranging, adaptive randomised phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):674-684. doi: 10.1016/S1473-3099(15)00479-X. Epub 2016 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age \\>= 18 years and \\< 50 years\n* Malaria blood thick film positive\n* Presence of gametocytes on thick blood film\n* Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits\n* No allergies to study drugs\n* Hemoglobin \\>= 8 g/dl\n* No evidence of severe or chronic disease\n* Written, informed consent'}, 'identificationModule': {'nctId': 'NCT01743820', 'briefTitle': 'Phase2a Primaquine Dose Escalation Study', 'nctIdAliases': ['NCT02011555'], 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Phase 2a Dose Escalation Study of the Efficacy, Safety, and Pharmacokinetics of Low Dose Primaquine for Gametocytocidal Activity Against P. Falciparum in Sub-Saharan Africa and South East Asia', 'orgStudyIdInfo': {'id': 'MEG001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dihydroartemisinin-piperaquine only', 'description': 'dihydroartemisinin -piperaquine (DP) only', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine']}, {'type': 'EXPERIMENTAL', 'label': 'DP and 0.125 mg/kg primaquine', 'description': 'DP and single dose oral 0.125 mg/kg primaquine', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine', 'Drug: 0.125 mg/kg Primaquine']}, {'type': 'EXPERIMENTAL', 'label': 'DP and 0.5 mg/kg primaquine', 'description': 'DP and single dose oral 0.5 mg/kg primaquine', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine', 'Drug: 0.5 mg/kg Primaquine']}, {'type': 'EXPERIMENTAL', 'label': 'DP and 0.25 mg/kg primaquine', 'description': 'DP and a single dose oral 0.25 mg/kg primaquine', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine', 'Drug: 0.25 mg/kg Primaquine']}, {'type': 'EXPERIMENTAL', 'label': 'DP and 0.0625 mg/kg primaquine', 'description': 'DP and a single dose oral 0.0625 mg/kg primaquine', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine', 'Drug: 0.0625 mg/kg Primaquine']}], 'interventions': [{'name': 'dihydroartemisinin-piperaquine', 'type': 'DRUG', 'armGroupLabels': ['DP and 0.0625 mg/kg primaquine', 'DP and 0.125 mg/kg primaquine', 'DP and 0.25 mg/kg primaquine', 'DP and 0.5 mg/kg primaquine', 'dihydroartemisinin-piperaquine only']}, {'name': '0.125 mg/kg Primaquine', 'type': 'DRUG', 'armGroupLabels': ['DP and 0.125 mg/kg primaquine']}, {'name': '0.5 mg/kg Primaquine', 'type': 'DRUG', 'armGroupLabels': ['DP and 0.5 mg/kg primaquine']}, {'name': '0.25 mg/kg Primaquine', 'type': 'DRUG', 'armGroupLabels': ['DP and 0.25 mg/kg primaquine']}, {'name': '0.0625 mg/kg Primaquine', 'type': 'DRUG', 'armGroupLabels': ['DP and 0.0625 mg/kg primaquine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bamako', 'country': 'Mali', 'facility': 'Malaria Research and Training Centre', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}], 'overallOfficials': [{'name': 'Roland Gosling, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Alassane Dicko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Malaria Research and Training Centre'}, {'name': 'François Nosten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shoklo Malaria Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Malaria Research and Training Center, Bamako, Mali', 'class': 'OTHER'}, {'name': 'Shoklo Malaria Research Unit', 'class': 'OTHER'}, {'name': 'Mahidol Oxford Tropical Medicine Research Unit', 'class': 'OTHER'}, {'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'Wellcome Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}