Clinical trials

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. In 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. Participants 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.

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).

A non randomized observation study that is aiming to assess the safety and efficacy of high dose primaquine (1mg/kg 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 (\<30% activity)

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.

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: * is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days) * is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg) * is the tolerability and safety of TQRevised acceptable * 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.

The vision of the Communicate Study Partnership is to ensure more Aboriginal patients receive culturally safe healthcare in their first language. The 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. Quantitative 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. Successful project implementation will improve experience of care and health outcomes for Aboriginal people, build Aboriginal workforce, and improve healthcare provider satisfaction.