Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT07060794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tafenoquine and DHA-piperaquine (TADORE- Plus)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence risk (time to first event) of any P. vivax parasitaemia', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vivax Malaria']}, 'descriptionModule': {'briefSummary': 'A trial designed to determine whether there is a clinically significant drug-drug interaction of tafenoquine with DHA-piperaquine using a control arm with radical cure given at the end of follow up (delayed radical cure).'}, '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\n* as determined by the Standard G6PD (SD Biosensor, ROK))\n* Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours\n* Age ≥18 years\n* Haemoglobin at presentation ≥8g/dl\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* Pregnant or lactating females\n* Regular use of drugs with haemolytic potential\n* Known hypersensitivity to any of the study drugs\n* History of any psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT07060794', 'acronym': 'TADORE+', 'briefTitle': 'Tafenoquine and DHA-piperaquine (TADORE- Plus)', 'organization': {'class': 'OTHER', 'fullName': 'Menzies School of Health Research'}, 'officialTitle': 'Tafenoquine and DHA-piperaquine (TADORE- Plus)', 'orgStudyIdInfo': {'id': 'TADORE+'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tafenoquine plus DHA-Piperaquine', 'interventionNames': ['Drug: Tafenoquine']}, {'type': 'NO_INTERVENTION', 'label': 'DHA-Piperaquine'}], 'interventions': [{'name': 'Tafenoquine', 'type': 'DRUG', 'description': 'Tafenoquine in combination with DHA-piperaquine', 'armGroupLabels': ['Tafenoquine plus DHA-Piperaquine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hellen Mnjala', 'role': 'CONTACT', 'email': 'hellen.mnjala@menzies.edu.au', 'phone': '000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Submission to WWARN'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menzies School of Health Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}