Darwin City

Researchers are studying children aged 1 to 18 years with acute, uncomplicated bone and joint infections (BJIs) at eight major pediatric hospitals in Australia and New Zealand. This Phase 4 trial aims to find out if treating these infections entirely with oral antibiotics is as effective as the standard treatment, which starts with 1 to 7 days of intravenous (IV) antibiotics followed by oral antibiotics. The goal is to determine if children can fully recover 3 months after starting treatment without needing IV antibiotics initially. Children in the trial will be randomly assigned to one of two groups. One group will receive the standard treatment, which includes IV cefazolin or IV flucloxacillin for 1 to 7 days followed by 3 weeks of high-dose oral cefalexin. The other group will receive only high-dose oral cefalexin for the treatment duration. The outcomes of these two groups will be compared to assess whether the oral-only approach is not inferior to the standard IV plus oral treatment. During the study, children will be closely monitored and assessed for recovery at 3 months after treatment begins. Researchers will evaluate the proportion of children who have fully recovered from their infections. Safety and treatment effectiveness will be tracked throughout the study, with all data collected from the participating hospitals. The total participation duration includes the initial treatment period followed by the 3-month evaluation point for recovery.

Researchers are evaluating treatment options for patients with early-stage classical Hodgkin lymphoma who have not received prior therapy. This international phase III trial runs two parallel studies in different regions, combining data to better understand treatment effects. The trial compares two chemotherapy regimens, ABVD and A2VD, with treatment adapted based on PET-CT scan results after two cycles to guide further therapy. Participants will be randomly assigned to receive either ABVD chemotherapy (doxorubicin, bleomycin, vinblastine, and dacarbazine) or A2VD chemotherapy (doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine with growth factor support). PET-CT scans are performed after one cycle for exploratory purposes and after two cycles to determine subsequent treatment. Depending on PET results, patients may receive additional chemotherapy cycles or involved site radiotherapy following ILROG guidelines. Those with poor response discontinue trial treatment and receive alternative therapy. During the study, patients undergo PET-CT scans and regular assessments to monitor treatment response and safety. Follow-up continues for at least five years after treatment completion to assess progression-free survival. Researchers collect clinical data and imaging results to evaluate outcomes, with central review of PET scans guiding treatment adaptations. Participants are monitored for side effects and overall health throughout the trial period.

Each year, over 7,000 Australians suffer severe trauma that can cause serious bleeding and poor outcomes. This trauma can disrupt the body's ability to form blood clots, leading to excessive bleeding. Early replacement of clotting factors, especially fibrinogen which helps bind clots together, may improve recovery. This trial, called FEISTY II, is a phase III study comparing two methods of fibrinogen replacement in adults with major trauma and bleeding. The study compares fibrinogen concentrate, a dry powder that can be quickly reconstituted and given at the bedside, with cryoprecipitate, a blood product that requires thawing before use and is harder to supply, especially in remote areas. Participants will receive either 3 grams of fibrinogen concentrate or standard doses of cryoprecipitate (10 units whole blood or 4 units apheresis). This approach aims to evaluate the effectiveness, safety, and cost of these treatments in managing severe bleeding after trauma. Participants will be adults with trauma who are actively bleeding and require emergency blood transfusions. Researchers will monitor the number of days participants are alive and out of the hospital within 90 days after injury. The study will also assess safety and resource use. A total of 850 patients will be enrolled from major trauma centers in Australia and New Zealand, with follow-up to 90 days post-injury.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

This research aims to observe and understand people living with chronic hepatitis B in Australia. It focuses on tracking how these individuals are linked to care and their treatment needs through a national network of diverse healthcare services. The study includes individuals diagnosed with chronic hepatitis B, whether newly or previously diagnosed, to provide a comprehensive view of this population. Participants will not receive any new treatments or interventions as part of this study. Instead, researchers will collect enrollment data such as demographics, laboratory test results, liver disease assessments, treatment history, and clinical management information from those attending participating clinics for hepatitis B care. Follow-up data on treatment, clinical management, liver disease stage, and laboratory parameters will be gathered at each visit or at least once every 12 months. Participants will be involved through regular visits to healthcare services where their health information related to hepatitis B care will be recorded and monitored over time. Researchers will assess laboratory results, disease progression, and treatment patterns to characterize the hepatitis B infection within this group. The main study outcome is to understand the characteristics of hepatitis B in this population by July 2027, with ongoing data collection during the study period.

Researchers are examining ways to improve healthcare experiences and outcomes for Aboriginal people in Northern Territory hospitals by providing culturally safe care in their first languages. This phase 2 study aims to create lasting organizational changes that promote cultural safety and clinical excellence, focusing on anti-racism training and increased use of Aboriginal interpreters and Aboriginal Health Practitioners. The study includes both quantitative measures such as interpreter use and hospital stay outcomes, and qualitative insights from interviews with patients, healthcare providers, and interpreters. The study implements a behavioral intervention called 'Ask the Specialist Plus,' which offers anti-racism training through moderated discussions and reflections on podcast episodes. Additional strategies include fostering clinical champions of cultural safety via social media and meetings, simplifying interpreter booking processes, supporting interpreter retention and training, and optimizing interpreter deployment within hospital teams. Continuous quality improvement cycles involving senior managers use data from the study to refine these interventions. Participants, including Aboriginal patients, interpreters, and healthcare providers of any ethnicity, will engage in interviews, observations, and surveys throughout the study period from 2022 to 2026. Researchers will monitor interpreter uptake, patient self-discharge rates, readmissions, hospital stay length, and economic effects of interpreter use. Patient experiences will be tracked qualitatively over time to assess changes during the intervention. The study intends to enhance the Aboriginal workforce and improve provider satisfaction while advancing culturally safe healthcare delivery.

Researchers are evaluating whether an early three-day course of oral dexamethasone can improve recovery and wellbeing in children aged 4 to 17 years with Sydenham's chorea, a movement disorder caused by inflammation in the brain after a Group A streptococcus infection. This condition affects children's movements, mood, and concentration, and can take months to fully recover from. The study is a randomized, double-blinded, placebo-controlled phase 3 trial conducted in New Zealand and Australia, focusing on reducing symptoms and improving mental health outcomes. Participants will be randomly assigned to receive either oral dexamethasone suspension at a dose of 20mg/m2/day (up to 24mg/day) divided into three doses daily for three days, or matching placebo capsules taken three times daily for the same duration. The study compares the effects of this short steroid course against placebo to determine safety and effectiveness in treating Sydenham's chorea. The trial plans to enroll 80 children from multiple hospital sites. During the study, children's chorea severity and psychiatric symptoms will be assessed at one, three, and twelve months using standardized rating scales and questionnaires. Safety checks for adverse events related to dexamethasone will occur on days three, seven, and at one month. Additional outcomes include relapse rates, hospital length of stay, and treatment failures. The total follow-up period spans a year to monitor both physical and mental recovery.