Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-08 @ 4:11 AM
Study NCT ID:
NCT02143934
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2014-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016780', 'term': 'Malaria, Vivax'}, {'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D008288', 'term': 'Malaria'}, {'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'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}], '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'}, {'id': 'D000077549', 'term': 'Artemether'}, {'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 524}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '2014-05-19', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first or only Plasmodium vivax infection by light microscopy and PCR', 'timeFrame': '8 months post-baseline'}, {'measure': 'Time to first or only clinical P. vivax episode', 'timeFrame': '8 months post-baseline'}], 'secondaryOutcomes': [{'measure': 'Time to first or only P. falciparum infection by light microscopy and PCR', 'timeFrame': '8 months post-baseline'}, {'measure': 'Time to first or only P. ovale infection by light microscopy and PCR', 'timeFrame': '8 months post-baseline'}, {'measure': 'Time to first or only P. malariae infection by light microscopy and PCR', 'timeFrame': '8 months post-baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plasmodium vivax', 'Hypnozoites', 'Primaquine', 'Liver-stage', 'Blood-stage', 'Plasmodium falciparum'], 'conditions': ['Plasmodium Vivax Infection', 'Plasmodium Vivax Clinical Episode', 'Plasmodium Falciparum Infection', 'Plasmodium Falciparum Clinical Episode']}, 'referencesModule': {'references': [{'pmid': '38115002', 'type': 'DERIVED', 'citation': 'Potter GE, Callier V, Shrestha B, Joshi S, Dwivedi A, Silva JC, Laurens MB, Follmann DA, Deye GA. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials? Malar J. 2023 Dec 19;22(1):383. doi: 10.1186/s12936-023-04802-0.'}, {'pmid': '37790581', 'type': 'DERIVED', 'citation': 'Potter GE, Callier V, Shrestha B, Joshi S, Dwivedi A, Silva JC, Laurens MB, Follmann DA, Deye GA. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials? Res Sq [Preprint]. 2023 Sep 22:rs.3.rs-3370731. doi: 10.21203/rs.3.rs-3370731/v1.'}, {'pmid': '36534705', 'type': 'DERIVED', 'citation': 'Stadler E, Cromer D, Mehra S, Adekunle AI, Flegg JA, Anstey NM, Watson JA, Chu CS, Mueller I, Robinson LJ, Schlub TE, Davenport MP, Khoury DS. Population heterogeneity in Plasmodium vivax relapse risk. PLoS Negl Trop Dis. 2022 Dec 19;16(12):e0010990. doi: 10.1371/journal.pntd.0010990. eCollection 2022 Dec.'}, {'pmid': '36099312', 'type': 'DERIVED', 'citation': 'Holzschuh A, Gruenberg M, Hofmann NE, Wampfler R, Kiniboro B, Robinson LJ, Mueller I, Felger I, White MT. Co-infection of the four major Plasmodium species: Effects on densities and gametocyte carriage. PLoS Negl Trop Dis. 2022 Sep 13;16(9):e0010760. doi: 10.1371/journal.pntd.0010760. eCollection 2022 Sep.'}, {'pmid': '28862132', 'type': 'DERIVED', 'citation': 'Hofmann NE, Karl S, Wampfler R, Kiniboro B, Teliki A, Iga J, Waltmann A, Betuela I, Felger I, Robinson LJ, Mueller I. The complex relationship of exposure to new Plasmodium infections and incidence of clinical malaria in Papua New Guinea. Elife. 2017 Sep 1;6:e23708. doi: 10.7554/eLife.23708.'}, {'pmid': '28732068', 'type': 'DERIVED', 'citation': 'Wampfler R, Hofmann NE, Karl S, Betuela I, Kinboro B, Lorry L, Silkey M, Robinson LJ, Mueller I, Felger I. Effects of liver-stage clearance by Primaquine on gametocyte carriage of Plasmodium vivax and P. falciparum. PLoS Negl Trop Dis. 2017 Jul 21;11(7):e0005753. doi: 10.1371/journal.pntd.0005753. eCollection 2017 Jul.'}, {'pmid': '26505753', 'type': 'DERIVED', 'citation': 'Robinson LJ, Wampfler R, Betuela I, Karl S, White MT, Li Wai Suen CS, Hofmann NE, Kinboro B, Waltmann A, Brewster J, Lorry L, Tarongka N, Samol L, Silkey M, Bassat Q, Siba PM, Schofield L, Felger I, Mueller I. Strategies for understanding and reducing the Plasmodium vivax and Plasmodium ovale hypnozoite reservoir in Papua New Guinean children: a randomised placebo-controlled trial and mathematical model. PLoS Med. 2015 Oct 27;12(10):e1001891. doi: 10.1371/journal.pmed.1001891. eCollection 2015 Oct.'}]}, 'descriptionModule': {'briefSummary': 'This study specifically seeks to quantify the contribution of relapes to the burden of P. vivax infections and disease by determining on the effect of radical pre-erythrocytic and erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in children aged 5-10 years in a treatment to re-infection study design. In order the clear liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days, standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days, 0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks.\n\nIn addition to this epidemiological data, the study will assess the natural acquisition of cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG children aged 5-10 years.\n\nThese data will not only be essential for development of future vaccines against P. vivax and P falciparum but provide invaluable insight into the contribution of long-lasting liver-stages to the force of infection with P. vivax that will contribute towards designing more rational approaches to the treatment of P. vivax both in the context of case management and future attempts at elimination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 5-10 years (±3 months)\n* permanent residents of the area\n* absence of history of hypersensitivity reactions to the drugs\n\nExclusion Criteria:\n\n* chronic illness\n* severe malnutrition (weight-for-age nutritional Z score \\[WAZ\\] \\<60th percentile)\n* severe anemia (Hb \\<5 g/dL),\n* G-6-PD deficiency (\\<60% G-6-PD activity)\n* permanent disability, which prevents or impedes study participation. Any 1 or more of the criteria is sufficient to exclude study participation.'}, 'identificationModule': {'nctId': 'NCT02143934', 'briefTitle': 'Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Papua New Guinea Institute of Medical Research'}, 'officialTitle': 'Host and Parasites Factors Contributing to Risk of Plasmodium Re-infection and Morbidity in Elementary School Children in Maprik, East Sepik Province', 'orgStudyIdInfo': {'id': '07200734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Primaquine', 'description': 'Primaquine, 0.5mg/kg/day, 20 days directly observed treatment Chloroquine, 25mg/kg total dose, divided over 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD', 'interventionNames': ['Drug: Primaquine', 'Drug: Chloroquine', 'Drug: Artemether Lumefantrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD', 'interventionNames': ['Drug: Placebo', 'Drug: Chloroquine', 'Drug: Artemether Lumefantrine']}], 'interventions': [{'name': 'Primaquine', 'type': 'DRUG', 'armGroupLabels': ['Primaquine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar pills, appearance identical to Primaquine tablets', 'armGroupLabels': ['Placebo']}, {'name': 'Chloroquine', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Primaquine']}, {'name': 'Artemether Lumefantrine', 'type': 'DRUG', 'otherNames': ['Coartem'], 'armGroupLabels': ['Placebo', 'Primaquine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maprik', 'state': 'East Sepik Province', 'country': 'Papua New Guinea', 'facility': 'PNG Institute of Medical Research', 'geoPoint': {'lat': -3.62714, 'lon': 143.05422}}], 'overallOfficials': [{'name': 'Ivo Mueller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter and Eliza Hall Institute of Medical Research; Centre de Recerca en Salut Internacional de Barcelona (CRESIB)'}, {'name': 'Inoni Betuela, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PNG Institute of Medical Research'}, {'name': 'Louis Schofield, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter and Eliza Hall Institute of Medical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papua New Guinea Institute of Medical Research', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Walter and Eliza Hall Institute of Medical Research', 'class': 'OTHER'}, {'name': 'Swiss Tropical & Public Health Institute', 'class': 'OTHER'}, {'name': 'Barcelona Centre for International Health Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}