Surfers Paradise

Researchers are evaluating the safety of increasing doses of 131I-TLX101 given intravenously alongside standard care in patients newly diagnosed with glioblastoma, a type of brain tumor. This open-label, single-arm, multicenter Phase 1 study focuses on patients with histologically confirmed glioblastoma who have undergone surgery but not yet received systemic or radiation therapy. Participants receive ascending doses of 131I-IPA intravenously via infusion combined with the best standard of care, including planned chemoradiation therapy starting 3 to 6 weeks after surgery. The study monitors safety and dose-limiting toxicities over multiple dose levels to identify the recommended Phase 2 dose. During the 62-week study, participants undergo regular evaluations including clinical assessments, lab tests such as liver function, and monitoring for treatment-emergent adverse events. Researchers measure the incidence and severity of dose-limiting toxicities from the first dose until discharge after the second dose, along with overall safety and tolerability throughout the study period.

Researchers are conducting a multi-center, prospective, longitudinal cohort study to collect immunological and clinical data on Epstein-Barr Virus (EBV) reactivation in adults aged 18 to 29 years who are EBV seropositive. The study focuses on understanding EBV activity in healthy volunteers within this age group without introducing any experimental treatments or vaccines. Participants will undergo investigational procedures involving regular blood and saliva sample collections to monitor EBV presence and activity. No investigational medicinal products will be administered during the study. The study will take place over either a 6-month or 12-month period, following about 100 participants in Australia. Throughout the study, participants will be assessed for EBV DNA levels in blood and saliva, as well as serology testing for markers indicative of EBV reactivation, including anti-VCA IgG/IgM, anti-EBNA-1 IgG, and anti-EA IgG. These measures will be evaluated at each study visit to gather comprehensive data on the virus's behavior over time.

Researchers are evaluating the safety and tolerability of DB-1311/BNT324 in adults with advanced or metastatic solid tumors in this Phase 1/2a trial. The study includes a dose-escalation phase to find the maximum tolerated dose and recommended Phase 2 dose, followed by a dose-expansion phase to confirm safety and explore effectiveness, including in prostate cancer patients receiving novel hormone therapy. Additionally, a sub-study will assess the effects of other drugs on DB-1311's behavior in the body. During Phase 1, participants receive increasing doses of DB-1311 administered intravenously using an accelerated titration and classic 3+3 design to determine safe dosage levels. Phase 2a expands on this to further evaluate safety and tolerability, with DB-1311 given alone or combined with hormone therapy drugs such as enzalutamide or abiraterone for prostate cancer. The study also investigates drug interactions with lopinavir/ritonavir and itraconazole. Treatment schedules and dosing details follow the study protocol at multiple centers. Participants will undergo various assessments including safety labs, vital signs, electrocardiograms, heart function tests, and performance status evaluations up to approximately one year after treatment. Researchers will monitor treatment-related toxicities, serious adverse events, and response rates. The involvement includes tumor biopsies for biomarker analysis and adherence to follow-up visits. The total study duration varies by phase, with ongoing safety and efficacy monitoring throughout.

Researchers are investigating treatments for patients with acute ischemic stroke caused by basilar artery occlusion within 24 hours of symptom onset. This trial is designed as a multi-arm, multi-stage, prospective, randomized, open-label study with blinded endpoint evaluation. It involves a seamless transition from phase 2b to phase 3 if early results meet success criteria. The main goal is to see if tenecteplase combined with mechanical thrombectomy is better than standard care, including alteplase or no thrombolytic treatment, in achieving excellent functional recovery or returning patients to their previous level of function by 90 days. Participants will be randomly assigned to receive either tenecteplase at 0.25 mg/kg as an intravenous bolus or standard care, which may include intravenous alteplase at 0.9 mg/kg administered as a bolus followed by an infusion. Treatments will be given before mechanical thrombectomy if needed, based on the treating clinician's judgment. The study uses an adaptive design with sample size adjustments based on interim analyses, with a minimum of 320 and a maximum of 688 patients planned. The trial will be conducted across multiple regions and centers, with randomization stratified by planned mechanical thrombectomy and alteplase use. During the 12-month participation period, patients will be assessed for recovery using the modified Rankin Scale at 90 days as the primary outcome. Researchers will monitor recanalization success without symptomatic brain bleeding as an intermediate outcome. Assessments include imaging to confirm the basilar artery occlusion, functional evaluations, and safety monitoring. The study aims to gather data on the best treatment approach to improve outcomes for this serious type of stroke.

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.

Mycobacterium abscessus (MABS) is a group of rapidly growing, multi-drug resistant bacteria that can cause serious lung infections, especially in people with underlying inflammatory lung conditions. These infections, called MABS pulmonary disease (MABS-PD), can lead to worsened lung function, increased healthcare needs, and reduced quality of life. The trial, called Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT), aims to find the best treatment plans to clear MABS infections while minimizing side effects and treatment burdens. It also seeks to develop biomarkers to help guide treatment decisions and measure disease severity. The trial uses an innovative platform design to test and improve different treatment combinations for both children and adults with MABS-PD. Treatments include various intravenous and oral antibiotics such as amikacin, tigecycline, imipenem, cefoxitin, azithromycin, clarithromycin, clofazimine, ethambutol, linezolid, co-trimoxazole, doxycycline, moxifloxacin, bedaquiline, and rifabutin. The study includes phases of intensive intravenous therapy followed by consolidation with oral and/or inhaled antibiotics. Different durations and combinations of therapy are tested, including short and prolonged intensive treatments and consolidation therapies with or without inhaled amikacin. Participants will be involved in the study for up to 62 weeks, depending on their treatment group. Throughout the study, researchers will collect respiratory samples to monitor bacterial clearance and evaluate tolerance to treatments using standardized criteria for side effects. Additional assessments include quality of life measures, gene expression, imaging, and antibiotic resistance studies. The trial also includes an observational cohort for participants not receiving active treatment, allowing transition to the intervention program if eligible. Safety and treatment response will be closely monitored during and after therapy.

Researchers are evaluating the use of fludrocortisone compared to placebo in patients who have experienced aneurysmal subarachnoid haemorrhage (aSAH), a severe type of stroke often affecting younger adults with significant risk of death and lasting neurological problems. This Phase 2, multi-centre, blinded, randomized clinical trial aims to find out if early treatment with enteral fludrocortisone can reduce death and dependency six months after the event. The condition has a high mortality rate and many survivors suffer cognitive impairments that affect quality of life and ability to work. Managing complications like hyponatraemia is challenging and costly, creating a need for effective, low-cost treatments. Participants will receive either fludrocortisone tablets, containing 100mcg, or matched placebo tablets. Treatment is initiated early after hospital admission for aSAH and continues while patients are cared for in a critical care environment. The study compares these two groups to assess if fludrocortisone can prevent hyponatraemia and improve neurological outcomes. Previous smaller studies suggested potential benefits but were not definitive, and this trial aims to provide clearer evidence with modern care standards. During the study, participants are monitored closely with blood tests to track sodium levels and other clinical assessments to evaluate neurological function and recovery. The primary outcome measured is the Modified Rankin Scale at six months post-randomization, which assesses disability and dependence. Safety is also monitored, and participants are followed through their hospital stay and after discharge to capture long-term outcomes and any adverse effects. The total participation duration spans at least six months for outcome measurement.

Researchers are evaluating the safety and outcomes of different surgical margin sizes for adults with stage II primary invasive cutaneous melanoma. The trial compares the effects of removing 1 cm versus 2 cm of healthy skin around the melanoma site to see if smaller margins provide similar disease control. This study aims to understand if narrower excision margins can reduce surgery side effects and improve quality of life without increasing the risk of melanoma returning. Participants will be randomly assigned to undergo wide local excision surgery with either a 1 cm or 2 cm margin around the original melanoma scar. Both approaches involve removing an extra margin of skin to eliminate any remaining melanoma cells after the initial biopsy. Surgery is scheduled to be completed within 120 days after diagnosis and within 28 days after randomization. This phase III, multi-center trial will assess if the smaller margin is as effective as the larger one. During the study, patients will be followed for up to 60 months to monitor disease-free survival, which means the length of time without melanoma recurrence. Researchers will also evaluate quality of life, side effects from surgery, and the economic impact on health services. Participants will have regular clinical assessments, and outcomes will be recorded to determine the long-term safety and benefits of the two surgical approaches.

Researchers are evaluating ways to increase the use of antimicrobial stewardship resources by doctors treating adults with respiratory tract infections in Australian general practices. This study compares two types of implementation activities: face-to-face sessions in the Integrated Network group and virtual or online activities in the Virtual Network group. The goal is to find out which approach leads to more frequent use of these antimicrobial interventions. Doctors in the study will receive about seven hours of educational activities either through live interactive sessions and peer discussions (Integrated Network) or online self-paced modules and podcasts (Virtual Network). Both groups will have access to an online AMS Toolbox with resources for decision-making, delayed prescribing, and clinical support, including point-of-care tests to help identify infection types for some doctors. The study includes a baseline data collection over five months during winter, followed by implementation activities and another five months of data collection the following winter. Participants will track their use of antimicrobial interventions and report which ones they prefer. General practice staff will provide data on patient visits. Patients who saw participating doctors will be invited to complete surveys about their experiences, and a subgroup will take part in interviews. The main outcome measured is the change in the use of antimicrobial stewardship interventions per 100 consultations, monitored over the study period. Safety is monitored through patient-reported outcomes and reports from doctors, with an independent monitor overseeing the study's progress.

Researchers are evaluating the use of intra-arterial tenecteplase after mechanical thrombectomy in adults who have experienced an acute ischemic stroke caused by a large vessel occlusion in the anterior circulation. This is a multicenter, randomized, placebo-controlled, double-blind trial designed to test the safety and effectiveness of tenecteplase compared to best standard care. The trial includes both phase 2b and phase 3 stages to assess early neurological improvement and functional independence over time. Participants are randomly assigned to receive either a bolus injection of intra-arterial tenecteplase (0.062 mg/kg, max 6.25 mg) delivered through a microcatheter at the site of the clot after thrombectomy, or a placebo consisting of an intra-arterial bolus of 0.9% Sodium Chloride solution. Treatment is administered within 24 hours of symptom onset. The trial uses a parallel assignment with two arms and equal randomization. During the study, participants undergo imaging such as CT or MR angiograms to confirm eligibility and monitor treatment effects. Early neurological improvement is assessed 24 to 36 hours after randomization, and functional independence is evaluated at 3 months. Safety measures and adherence to treatment protocols are closely monitored. The study includes follow-up visits to collect clinical and imaging data, with total participation extending over several months to capture treatment outcomes.