ANZCTR search results

To compare the outcome of daily intermittent intravenous dosing of ceftriaxone verses continuous intravenous infusion of cefazolin by looking at treatment duration in patients admitted with cellulitis to the CHQ at Home’s Hospital in the Home program from 1st of January 2020 to 30th of June 2024.

This study will evaluate an evidence-based online relationship program in an Australian context with individuals experiencing difficulties with alcohol or substance use, and dissatisfaction in their relationship with their intimate partner. The project will address major limitations in the AOD sector by taking a relationship science approach to address relationship dysfunction and breakdown in those couples where at least one partner is affected by substance misuse. Given that the OurRelationship program has already been shown to be highly effective in the wider community, the aim of this proposed project is translational in nature; specifically targeting individuals in the community who have unmet needs regarding problems in their relationships in the context of problematic substance use. It is expected that the application of the OurRelationship program to this section of the community will enhance their relationship functioning, confidence, stability, and quality, and reduce partner conflict and dysfunction.

This study is assessing the pharmacokinetics, safety and tolerability of single doses of eRapa compared to Rapamune in healthy volunteers. Who is it for? You may be eligible to join this study if you are aged between 18 and 65 years old who are overtly healthy as determined by screening study assessments. People who have been diagnosed with cancer will not be eligible for this study. Study details This healthy volunteer study is designed to compare the absorption of a new formulation of rapamycin called eRapa and a currently available formulation known as Rapamune for the treatment of familial adenomatous polyposis. Familial adenomatous polyposis (FAP) is a rare inherited disease that increases the risk of developing bowel cancer at an earlier age than the general population. Participants in this study are randomly allocated by simple randomisation to eRapa or Rapamune (rapamycin) as a first dose and then vice versa for the second dose 14-20 days after the first dose. Pharmacokinetics, safety and tolerability and will be assessed at regular intervals using clinical examinations and blood tests. The rate and predictability of the absorption of eRapa will be compared to Rapamune. It is hoped this research will contribute to improving clinical outcomes in patients with familial adenomatous polyposis (FAP) by preventing or delaying disease progression.

Despite how common and impactful child sleep problems are, they are not routinely treated within public hospital outpatient services, and there is a shortage of professionals trained in paediatric sleep. Our team has developed the Lights Out program, a caregiver-directed intervention that teaches practical strategies to manage child sleep problems. Research has shown that Lights Out improves children’s sleep, anxiety, and behaviour, as well as caregiver wellbeing, and can be delivered face-to-face or via videoconference. This study responds to an urgent request from Queensland’s two largest public hospital paediatric outpatient services to adapt the Lights Out program for routine care. Caregivers of children aged 3-to-12 years with sleep problems will be recruited from two paediatric outpatient clinics. Families will be randomly assigned to receive either the Lights Out program or usual care. Child sleep and wellbeing, as well as caregiver wellbeing, will be assessed over six months. The study will also examine how acceptable the program is for families and clinicians to support wider delivery in public health settings.

About 15% of the workforce in Australia do shift work, which can lead to sleep disturbance and circadian misalignment. This negatively impacts health and wellbeing and could impact organisational outcomes. In this study we plan to examine whether a digital sleep health intervention can improve sleep, mental health and organisational outcomes in healthcare workers. We also want to understand the feasibility and scalability of this tool and any enablers and barriers to workplace adoption of the app. Results from this study will help us understand the feasibility of the app to improve healthcare workers' sleep, improve organisational outcomes, and if it is feasible for workplace-level adoption.

The primary aim of the study is to define the point-prevalence of a Post-Viral Syndrome (PVS, Long COVID) at 12-24 weeks post SARS Cov-2 infection versus infective (RSV A/B or Influenza A/B) and non-infective controls using an operationalised PVS research case definition in the Australian community. The study will also help to understand: - how often SARS-CoV-2 infection and other respitatory viral infections cause PVS , - what symptoms (and symptom clusters) occur, and - what medical, mental health and functional impact those symptoms may have. We will screen-swab up to 10,000 participants aged 12+ with recent onset (<7 days) respiratory symptoms, to enroll a total of 500 confirmed acute SARS-CoV-2 infection cases, 500 Influenza cases and 500 RSV cases, as well as 500 non-infective control subjects across Australia. Participants will be tested for respiratory viruses including SARS-CoV-2, Influenza A/B, RSV A/B. Up to a total of 2000 participants who are positive for SARS CoV-2, Influenza A/B, RSV A/B and non-infective controls will be followed up at 6, 12, 24 and 48 weeks via self-reported questionnaires to assess for ongoing symptoms and application of a standardised PVS case definition. The OUTPOST cohort will provide a basis for health economic analysis. The cohort will complement a concurrent mapping exercise of existing studies and cohorts on Long COVID in addition to specialist support services and clinics around the country. Together, these project activities will inform better care and support for people experiencing Long COVID in Australia.

AXA-042 is a novel toll-like receptor (TLR) 2/6 agonist designed to re-engage the innate immune system and promote anti-tumour immune responses. In this first-in-human study, researchers will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumour activity of AXA-042 administered as monotherapy in participants with advanced solid tumours. This part of the study (Part C) will use a Simon’s two-stage design to identify early signals of clinical activity while minimising exposure to potentially ineffective treatment. Who is it for? You may be eligible for this study if you are 18 years of age or older, have a diagnosis of a locally advanced or metastatic solid tumour, and your cancer has progressed despite standard treatments or you are intolerant to standard of care therapies. Study details Participants will receive AXA-042 as monotherapy, administered as an intravenous infusion on Day 1 of a 21-day treatment cycle. Treatment will continue until disease progression, withdrawal of consent, unacceptable toxicity, investigator decision, or study completion. The dose of AXA-042 used in this part of the study will be selected based on available safety and pharmacokinetic/pharmacodynamic data from earlier parts of the study and confirmed by the Safety Monitoring Committee. Participants will be monitored closely for adverse events throughout treatment and for at least 30 days after the last dose. Blood samples will be collected to assess pharmacokinetics, immunogenicity, and pharmacodynamic biomarkers, including immune response markers and cytokine profiles. Tumour response will be evaluated using RECIST v1.1, iRECIST, and/or PERCIST criteria, as appropriate. Quality-of-life assessments will also be conducted during the study. It is hoped that this study will help determine whether AXA-042 monotherapy demonstrates sufficient biological and clinical activity in selected solid tumour types to support further clinical development.

The purpose of this Phase 1 study is to evaluate the safety, tolerability and PK profile of Smartech Aspirin, applied daily to the skin for 10 days, compared to topical vehicle control and orally administered immediate release (IR), low dose aspirin in healthy adult participants. The study will be initiated with 2 treatment cohorts as follows: 1. Topical Cohort (randomized, double-blind, vehicle-controlled): up to 10 evaluable participants will be enrolled and randomized to receive Smartech Aspirin (2 pumps of a nominal 179 mg per pump; 358 mg total per day) or vehicle control in a 4:1 ratio (8 active: 2 vehicle control), to be applied topically once daily (QD) for 10 days. 2. Oral Cohort (open-label): up to 8 evaluable participants will be enrolled and treated with oral, IR, low dose aspirin (81 mg) dosed QD for 10 days. Up to 2 additional cohort(s) of 10 participants each; i.e., Cohort A2 and Cohort A3, may be enrolled to further investigate the safety, tolerability and PK/PD of Smartech Topical Aspirin gel.

This study aims to directly compare the laboratory findings from samples collected from 10 healthy volunteers with results from a laboratory bladder infection model, using similar antibiotic therapy dosing. Laboratory testing involves measuring concentrations of amoxicillin and clavulanate in urine, assessing the activity of the antibiotic against E. coli uropathogens, and studying how the antibiotic affect the healthy microorganisms in the urinary tract, called the urobiome. Results from this study will validate the utility of the laboratory bladder infection model and help guide future research. This includes finding the best doses of antibiotics and testing other types of antimicrobials.

Piano training using creative improvisation provides opportunities for autonomy-supportive learning where participants can self-direct and express themselves through their musical play. Piano training using traditional methods often requires precise replication of music notation. This study aims to investigate the cognitive and wellbeing benefits experienced by older adults who participate in piano improvisation training compared to those who engage in traditional piano instruction, with particular attention to individuals who report memory concerns, formally referred to as subjective cognitive decline.