[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Menzies School of Health Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":167},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,71,96,121,142],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641007","phase-4-thrive---trial-of-passive-humoral-rsv-immunity-for-value-and-effectiveness-100641007",false,"NCT07578298","THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness","Passive Immunisation With RSV-specific Monoclonal Antibody (RSV-SMA) to Prevent RSV Respiratory Infections Among Aboriginal and Torres Strait Islander Children in the Northern Territory: a Pragmatic Randomised Controlled Trial.","THRIVE","Inclusion Criteria:\n\n1. Aboriginal and\u002For Torres Strait Islander infant ≥ 6 calendar months old and \\\u003C 9 calendar months old.\n2. Parent\u002Fcaregiver is willing for their infant to participate in the study and informed consent for the infant's participation in the study has been given.\n3. Parent\u002Fcaregiver is willing to comply with all study procedures outlined in the protocol, including review of maternal\u002F infant immunisation records, electronic medical records and public health notifications, for the duration of the study.\n\nExclusion Criteria:\n\n1. Infants with a contra-indication to RSV-SMA per the Australian Immunisation Handbook (i.e. anaphylaxis to a prior dose).\n2. Infants who have received a prior dose of RSV-SMA at ≥ 3 calendar months old.\n3. Previously enrolled in this trial.\n\nTemporary Exclusion Criteria\n\n1. Infants who have received a prior dose of RSV-SMA between ≥ 1 calendar months old and \\\u003C 3 calendar months old will be excluded until at least 150 days have passed since their most recent dose. Randomisation can be delayed until participants meet this criterion.\n2. Acute illness at the time of assessment (e.g. fever ≥ 38.5°C, acute respiratory or other infection as determined by trained and delegated study staff) is temporarily excluded until they are recovered and\u002For symptom-free for ≥ 24 hours.",true,"ALL","6 Months","9 Months",{"count":22,"type":23},1000,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in Australia's Northern Territory. The goal of this clinical trial is to evaluate whether routinely administering a single dose of respiratory syncytial virus (RSV)-specific monoclonal antibody, nirsevimab, from 6 months old, provides protection against RSV infections for Aboriginal and Torres Strait Islander children throughout in the first and second year of life.\n\nIn this study, participants will be randomly assigned to receive either a single dose of intra-muscular RSV-specific monoclonal antibody, nirsevimab, or standard care (no RSV-specific monoclonal antibody). The primary objective is to determine whether administration ofRSV-specific monoclonal antibody, nirsevimab reduces the occurrence of RSV infection over the subsequent 12 months. Secondary objectives include assessing whether nirsevimab reduces RSV-related hospital attendances, as well as respiratory and all-cause hospitalisations, over the following 6 and 12 months. An assessment of cost-effectiveness will also be undertaken.\n\nParticipants will receive the study intervention at 6 months of age (+90 days). Follow-up will be conducted through passive surveillance using electronic medical records and public health notification systems to capture relevant health outcomes.",[29,30],"Respiratory Syncytial Virus (RSV)","Respiratory Infection Virus",[29,32,33,34,35],"bayesian adaptive","pragmatic clinical trial","Aboriginal and Torres Strait Islander","infants","NOT_YET_RECRUITING","2026-05-05",{"date":39,"type":40},"2026-05-11","ACTUAL",{"date":42,"type":23},"2026-05-15",{"date":44,"type":23},"2030-12-31",{"name":46,"class":47},"Menzies School of Health Research","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100597615","phase-4-tafenoquine-and-acts-tadore--plus-100597615","NCT07060794","Tafenoquine and ACTs (TADORE- Plus)","TADORE+","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\u002Fdl\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","18 Years",{"count":58,"type":23},507,[26],"A trial designed to determine whether there is a clinically significant drug-drug interaction of tafenoquine with DHA-piperaquine or artesunate-pyronaridine using a control arm with radical cure given at the end of follow up (delayed radical cure).",[62],"Vivax Malaria","2026-03-16",{"date":65,"type":40},"2026-03-18",{"date":67,"type":23},"2026-06",{"date":69,"type":23},"2028-06",{"name":46,"class":47},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":24,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100628966","phase-4-primaquine-for-vivax-malaria-in-g6pd-intermediate-and-deficient-cases-100628966","NCT07468513","Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.","Inclusion Criteria:\n\n* • P. vivax peripheral parasitaemia (mono-infection)\n\n  * G6PD intermediate or deficient status (G6PD activity 30-\\\u003C70% or ≤30% 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  * Age ≥18 years\n  * Haemoglobin at presentation ≥8g\u002Fdl\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\n  * Pregnant or lactating females\n  * Regular use of drugs with haemolytic potential\n  * Known hypersensitivity to any of the study drugs.",{"count":78,"type":23},100,[26],"A non randomized observation study that is aiming to assess the safety and efficacy of high dose primaquine (1mg\u002Fkg per day over 7 days) among patients with intermediate (30-70%) G6PD activity and the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (\\\u003C30% activity)",[62,82],"G6PD Deficiency",[84,85],"Primaquine in G6PD deficiency","Vivax malaria in G6PD deficient patients","RECRUITING","2026-03-09",{"date":89,"type":40},"2026-03-12",{"date":91,"type":40},"2024-05-17",{"date":93,"type":23},"2028-12-31",{"name":46,"class":47},4,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":18,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":24,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100628967","phase-3-an-ultra-short-course-of-primaquine-for-the-radical-cure-of-vivax-malaria-100628967","NCT07468526","An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria","An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria (PRIMUS)","PRIMUS","Inclusion Criteria:\n\n* P. vivax peripheral parasitaemia as determined by microscopy\n* G6PD normal status (G6PD activity ≥70% of the site specific adjusted male median as determined by the Standard G6PD (SD Bioline, ROK))\n* Fever (temperature ≥37.5°C) or history of fever in the preceding 48 hours,\n* Age ≥5 years\n* Bodyweight ≥14kg\n* Living in the study area and willing to be followed-up for six months\n\nExclusion Criteria:\n\n* Signs or symptoms of severe malaria,\n* Anaemia (defined as Hb \\\u003C8g\u002Fdl) and measured by the Standard G6PD\n* Pregnant or lactating\n* Blood transfusion within the preceding four months\n* Regular or recent use (last month) of tafenoquine, primaquine or dapsone\n* Known hypersensitivity to any of the study drugs","5 Years",{"count":106,"type":23},1019,[108],"PHASE3","Current treatment regimens to prevent relapsing malaria are too long. A shorter higher dose treatment could improve treatment outcomes, but this needs to be balanced against increased risk of side effects. Recent data from a trial in children in Papua New Guinea (PNG) suggests a shortened treatment of 3 days is safe and effective. Our multicentre trial will assess the safety and efficacy of an ultra-short primaquine course. This trial is expected to directly influence global treatment policies.",[111],"Malaria",[113,102],"An ultra-short course of primaquine for the radical cure of vivax malaria",{"date":89,"type":40},{"date":116,"type":23},"2026-06-01",{"date":118,"type":23},"2028-04-01",{"name":46,"class":47},5,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":24,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":95},"100527517","phase-3-a-revised-tafenoquine-dose-to-improve-radical-cure-for-vivax-malaria-100527517","NCT06148792","A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria","A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised","TADORE","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 \\\u003C8g\u002Fdl)\n* Pregnant or lactating females\n* Regular use of drugs with haemolytic potential\n* Known hypersensitivity to any of the study drugs.",{"count":130,"type":23},1090,[108],"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\u002Fkg) non-inferior to high dose primaquine (7mg\u002Fkg over 7 days)\n* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg\u002Fkg) 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\u002Fkg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.",[62],"2025-07-15",{"date":136,"type":40},"2025-07-18",{"date":138,"type":40},"2024-05-10",{"date":140,"type":23},"2027-03-01",{"name":46,"class":47},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":24,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":95},"100487617","phase-2-the-communicate-study-partnership-100487617","NCT05629416","The Communicate Study Partnership","The Communicate Study Partnership - Improving Healthcare Experiences and Outcomes for Aboriginal Peoples Through Delivery of Culturally Safe Healthcare in First Languages","Inclusion Criteria:\n\nDifferent patient and provider participants (e.g. Aboriginal patients, Aboriginal interpreters, healthcare providers of any ethnicity) will be invited to participate in interviews, observations and surveys to assess effectiveness of study activities\n\nExclusion Criteria:\n\nNone",{"count":150,"type":23},340,[152],"PHASE2","The vision of the Communicate Study Partnership is to ensure more Aboriginal patients receive culturally safe healthcare in their first language.\n\nThe Communicate Study Partnership will implement and evaluate creative ways to embed cultural safety training and increase use of Aboriginal Interpreters and Aboriginal Health Practitioners at Northern Territory Top End hospitals.\n\nQuantitative outcomes (interpreter uptake, outcomes including leave against medical advice, costs) will be measured using time-series analysis. Qualitative outcomes derived from interviews with patient, healthcare provider and interpreter participants, will be informed by decolonising theory and participatory approaches.\n\nSuccessful project implementation will improve experience of care and health outcomes for Aboriginal people, build Aboriginal workforce, and improve healthcare provider satisfaction.",[155,156,157,158],"Aboriginal Health","Cultural Safety","Access to Interpreters","Healthcare Provider Training","2023-02-14",{"date":161,"type":40},"2023-02-16",{"date":163,"type":40},"2022-05-23",{"date":165,"type":23},"2026-12-31",{"name":46,"class":47},""]