Darwin City

Researchers are evaluating treatment options for children aged 1 to 18 years with acute, uncomplicated bone and joint infections BJIs in a multi-center trial across eight major pediatric hospitals in Australia and New Zealand. The study aims to determine if treating these infections entirely with oral antibiotics is not worse than the standard approach, which begins with 1 to 7 days of intravenous IV antibiotics followed by oral antibiotics. The goal is to see if children can fully recover without the need for IV treatment at 3 months after starting therapy. Children in the trial are randomly assigned to one of two groups. One group receives high-dose oral cefalexin four times daily for 1 to 7 days, followed by a standard dose of oral cefalexin three times daily to complete a total 3-week course. The other group receives standard treatment with IV cefazolin or IV flucloxacillin for 1 to 7 days, then oral cefalexin three times daily for 3 weeks. This comparison will help assess whether the oral-only treatment can effectively replace initial IV therapy. Throughout the study, children will be monitored for recovery status at 3 months, including assessment of full recovery, disease recurrence at 6 and 12 months, and any complications or treatment-related side effects. Researchers will also evaluate quality of life using various pediatric health scales, treatment adherence, and cost-effectiveness over 12 months. Medication use and adherence will be reviewed at 3 weeks to understand how well children follow the treatment plan.

This trial investigates treatment options for adults aged 16 to 69 with early-stage classical Hodgkin lymphoma, specifically stage I or II supradiaphragmatic disease without mediastinal bulk or B symptoms. The study compares two chemotherapy regimens ABVD and A2VD, using a PET response-adapted design to adjust therapy based on treatment response. It is a phase III, randomized, open-label trial conducted internationally and sponsored by University College London and Canadian Cancer Trials Group. 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. After two 28-day cycles, a PET-CT scan will assess response using the Deauville score to guide further treatment. Patients with scores 1-3 receive one more cycle those with score 4 receive two more cycles followed by involved site radiotherapy patients with score 5 discontinue trial treatment and receive alternative therapy as determined by their clinician. Throughout the study, participants undergo PET-CT scans and clinical assessments to monitor treatment response and safety. They will be followed for at least five years post-treatment to evaluate progression-free survival and other outcomes such as event-free survival, overall survival, and incidence of second cancers or cardiovascular disease. Safety and toxicity are monitored from treatment start until 30 days after completion. The overall study period extends until 2032.

Severe trauma can cause heavy bleeding and changes in blood clotting that make it hard for injured patients to stop bleeding effectively. This trial focuses on adults with severe trauma who experience low fibrinogen levels, a key clotting factor, to compare two ways of replacing fibrinogen during major bleeding. The study aims to evaluate the safety, effectiveness, and cost of fibrinogen concentrate versus cryoprecipitate, which is the current standard treatment made from donated blood. Participants will be randomly assigned to one of two groups one will receive fibrinogen concentrate, a dry powder that can be quickly prepared and given at the bedside, and the other will receive cryoprecipitate, which requires thawing before use and contains multiple clotting factors. Dosing is guided by specific clotting tests measuring fibrinogen levels. The study includes 850 patients from trauma centers in Australia and New Zealand and follows them for outcomes after treatment. During the study, researchers will monitor participants days alive and out of hospital up to 90 days after injury, along with other measures like blood transfusion amounts, mortality rates, organ failure, and quality of life over 12 months. Safety is assessed by tracking blood clot-related events and other complications. This phase III randomized trial uses blinded methods to ensure reliable results and includes careful follow-up to understand the impact of fibrinogen replacement in traumatic bleeding.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

This observational study focuses on people living with chronic hepatitis B in Australia. It aims to characterize and monitor how individuals link to care and their treatment needs across a wide network of healthcare services. The study is sponsored by the Kirby Institute and seeks to understand various aspects of hepatitis B management in a real-world setting. Participants are individuals diagnosed with chronic hepatitis B who have attended participating clinics for hepatitis B care within the past 12 months or are attending from the study start. There is no intervention as this is an observational study. Data collected includes demographics, lab results, liver disease assessments, treatment history, and clinical management details. Follow-up data will be gathered at each visit or at least every 12 months. During the study, participants will have their hepatitis B treatment and clinical management monitored regularly. Researchers will evaluate outcomes such as hepatitis B disease stage, treatment adherence, liver fibrosis progression, and surveillance for liver cancer. The study plans to collect data until July 2027, with ongoing observation to understand disease progression and care patterns over time.

This research aims to improve healthcare experiences and outcomes for Aboriginal people by embedding culturally safe healthcare practices and increasing the use of Aboriginal interpreters and health practitioners in Northern Territory hospitals. The study focuses on transforming healthcare culture through anti-racism training and enhancing communication to ensure care is delivered in patients first languages. It also evaluates the impact of these changes on patient outcomes and healthcare provider satisfaction using both quantitative data and qualitative interviews. The study involves implementing a behavioral intervention including anti-racism training called Ask the Specialist Plus, supporting clinical champions of cultural safety through social media and meetings, simplifying interpreter booking processes, and providing training and support to interpreters. Efficiency strategies to improve interpreter availability and retention are tailored to hospital sites. Continuous quality improvement cycles will use data collected through the study to guide ongoing improvements. Participants include Aboriginal patients, interpreters, and healthcare providers who will be involved in interviews, observations, and surveys throughout the study period from 2022 to 2026. Researchers will measure outcomes such as self-discharge rates, patient and provider experiences, interpreter use, hospital readmission rates, and cost-effectiveness. Data will be collected regularly across multiple hospitals to evaluate the interventions impact on cultural safety and healthcare delivery.

This research aims to find out whether an early three-day oral steroid treatment called dexamethasone can improve both physical and mental recovery in children with Sydenhams chorea. Sydenhams chorea is a movement disorder caused by brain inflammation after an abnormal immune response to certain bacterial infections, affecting childrens movements, mood, and concentration. The condition commonly affects children with acute rheumatic fever, and recovery can take months. The study is a phase 3, randomized, double-blinded, placebo-controlled trial involving children in New Zealand and Australia. Participants will be randomly assigned to receive either oral dexamethasone or a placebo for three days. The dexamethasone dose is 20 mg per square meter of body surface per day, divided into three doses, with a maximum of 24 mg per day. The placebo group will take matching capsules on the same schedule. This short course treatment is being tested to see if it reduces the severity of Sydenhams chorea and its psychiatric symptoms. Children in the study will be monitored through scheduled visits on days three, seven, one month, three months, and twelve months. Researchers will assess chorea severity, relapse rates, psychiatric symptoms, hospital stay length, and treatment failure. Safety will be checked for any side effects possibly related to dexamethasone. The trial plans to recruit 80 participants, and overall involvement may last up to 12 months to track recovery and treatment effects comprehensively.