Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT06148792
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2023-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016780', 'term': 'Malaria, Vivax'}], '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': 'C055852', 'term': 'tafenoquine'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1090}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2023-11-19', 'studyFirstSubmitQcDate': '2023-11-19', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence risk of vivax parasitaemia', 'timeFrame': '4 months', 'description': 'The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy.\n\n* compared between TQRevised and the PQ7 (non-inferiority)\n* compared between TQRevised and TQStandard (superiority)'}], 'secondaryOutcomes': [{'measure': 'The incidence risk of vivax parasitaemia', 'timeFrame': '4 months', 'description': 'The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy compared between TQStandard and PQ7'}, {'measure': 'The incidence risk of symptomatic vivax parasitaemia', 'timeFrame': '4 months', 'description': 'The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 4 months follow up period as determined by microscopy'}, {'measure': 'The incidence risk of vivax parasitaemia', 'timeFrame': '6 months', 'description': 'The incidence risk (time to first event) of any P. vivax parasitaemia at 6-month follow up as determined by microscopy'}, {'measure': 'The incidence risk of symptomatic vivax parasitaemia', 'timeFrame': '6 months', 'description': 'The incidence risk (time to first event) of symptomatic P. vivax parasitaemia at 6-month follow up as determined by microscopy'}, {'measure': 'The incidence rate of vivax parasitaemia', 'timeFrame': '6 months', 'description': 'The incidence rate (events per person-time) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy'}, {'measure': 'The incidence rate of symptomatic vivax parasitaemia', 'timeFrame': '6 months', 'description': 'The incidence rate (events per person-time) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy'}, {'measure': 'The incidence risk of anaemia', 'timeFrame': '7 and 14 days, 6 months', 'description': 'The incidence risk of developing severe anaemia (Hb \\< 5g/dl) or moderate (5g/dl and \\<7g/dl) anaemia within 7 and 14 days of starting treatment and/or requiring blood transfusion within the 6 months follow up period'}, {'measure': 'The incidence risk of an acute drop in Hb', 'timeFrame': '7 and 14 days', 'description': 'The incidence risk of an acute drop in Hb of \\>25% to \\<7g/dl within 7 and 14 days of starting treatment'}, {'measure': 'Adverse events', 'timeFrame': '42 days', 'description': 'The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment'}, {'measure': 'Meth Hb concentration', 'timeFrame': 'day 7', 'description': 'day 7 methaemoglobin concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vivax Malaria']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question\\[s\\] it aims to answer are:\n\n* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days)\n* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg)\n* is the tolerability and safety of TQRevised acceptable\n* is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* P. vivax peripheral parasitaemia (mono-infection)\n* G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))\n* Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours\n* Written informed consent\n* Living in the study area and willing to be followed for six months\n\nExclusion Criteria:\n\n* Danger signs or symptoms of severe malaria\n* Anaemia (defined as Hb \\<8g/dl)\n* Pregnant or lactating females\n* Regular use of drugs with haemolytic potential\n* Known hypersensitivity to any of the study drugs.'}, 'identificationModule': {'nctId': 'NCT06148792', 'acronym': 'TADORE', 'briefTitle': 'A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria', 'organization': {'class': 'OTHER', 'fullName': 'Menzies School of Health Research'}, 'officialTitle': 'A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised', 'orgStudyIdInfo': {'id': 'TADORE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQRevised', 'description': 'Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg)', 'interventionNames': ['Drug: Tafenoquine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TQStandard', 'description': 'Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)', 'interventionNames': ['Drug: Tafenoquine']}, {'type': 'EXPERIMENTAL', 'label': 'PQ7', 'description': 'Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7)', 'interventionNames': ['Drug: Primaquine']}], 'interventions': [{'name': 'Tafenoquine', 'type': 'DRUG', 'description': 'oral treatment', 'armGroupLabels': ['TQRevised', 'TQStandard']}, {'name': 'Primaquine', 'type': 'DRUG', 'description': 'oral treatment', 'armGroupLabels': ['PQ7']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manaus', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Dr Marcus Lacerda', 'geoPoint': {'lat': -3.10194, 'lon': -60.025}}, {'city': 'Arba Minch', 'status': 'RECRUITING', 'country': 'Ethiopia', 'contacts': [{'name': 'Tamiru Shibiru Degaga, MD', 'role': 'CONTACT'}], 'facility': 'Arba Minch General Hospital', 'geoPoint': {'lat': 6.03333, 'lon': 37.55}}, {'city': 'Hanura', 'status': 'NOT_YET_RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Inge Prof Sutanto', 'role': 'CONTACT', 'email': 'sutanto.inge@yahoo.com', 'phone': '000'}, {'name': 'Erni Dr Juwita', 'role': 'CONTACT'}], 'facility': 'Puskesmas Hanura', 'geoPoint': {'lat': -6.60861, 'lon': 107.40222}}, {'city': 'Alexishafen', 'status': 'RECRUITING', 'country': 'Papua New Guinea', 'facility': 'Dr Moses Laman and Dr Brioni Moore', 'geoPoint': {'lat': -5.09074, 'lon': 145.80288}}], 'centralContacts': [{'name': 'Hellen Mnjala', 'role': 'CONTACT', 'email': 'hellen.mnjala@menzies.edu.au', 'phone': '+610889468675'}, {'name': 'kamala K Thriemer', 'role': 'CONTACT', 'email': 'kamala.ley-thriemer@menzies.edu.au', 'phone': '+610889468644'}], 'overallOfficials': [{'name': 'Kamala N Thriemer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menzies School of Health Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menzies School of Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Melbourne', 'class': 'OTHER'}, {'name': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado', 'class': 'OTHER'}, {'name': 'Arba Minch University', 'class': 'OTHER'}, {'name': 'Addis Ababa University', 'class': 'OTHER'}, {'name': 'Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia', 'class': 'UNKNOWN'}, {'name': 'Curtin University', 'class': 'OTHER'}, {'name': 'Papua New Guinea Institute of Medical Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}