ANZCTR search results

Invasive group A Strep (iGAS) is a severe infection that can lead to death or lifelong disability in people of all ages. When someone is diagnosed with iGAS, their household members have a much higher risk (2000x) of developing the same infection within the next month, a condition known as secondary iGAS, similar to the risk associated with meningococcal disease. While close contacts of meningococcal disease cases are routinely prescribed preventive antibiotics, only mother-baby pairs are routinely given preventive antibiotics for secondary iGAS, leaving a lack of guidance for other household members. The ISAAC study aims to understand if other household contacts of iGAS cases should also be prescribed preventive antibiotics. The study also aims to find out if taking a single dose of oral azithromycin is better than not taking any antibiotics at all, and if taking this shorter, single-dose oral antibiotic course could be as effective as the currently recommended longer or injectable antibiotic courses. Because these options are either long or painful, a single once-off oral medication (that you swallow) might be more preferable to household members. The trial aims to inform the public health management of invasive Strep A (iGAS) infections. Currently, household contacts are at a 2000 fold higher risk of also becoming unwell with iGAS in the 30 days after an initial case of iGAS. We think antibiotics are important to reduce this risk, but need to demonstrate both effectiveness of antibiotics and which antibiotic is the best to use. These are the main two questions of the trial. By generating evidence on the need for preventive antibiotics among household contacts of iGAS cases and exploring alternative antibiotic options, the ISAAC study hopes to better inform public health authorities and doctors across Australia on how to best manage iGAS cases.

This study will assess multiomics of intestinal microbial composition and the relationship with other metabolic components, including short-chain fatty acids (SCFA) and immune cell function, which will inform for improvements of health outcomes in Transplant and Cellular Therapy recipients.

This study aims to examine the impact of two different group interventions for parents who are presenting with mental health concerns. In particular the trial aims to see if any group is more effective for parents who present with disturbances of self organisation (DSO). DSO consists of emotional dysregulation, negative self concept and difficulties in interpersonal relationships. In addition, it hopes to test if any group is better at supporting improved parent-child relationships.

Newborn infants admitted to a neonatal intensive care unit (NICU) are exposed to multiple episodes of painful stimuli. These are in the form of heel-prick blood sampling, venepuncture, intravenous line insertion and injections. Cold and mechanical distraction methods such as Buzzy® have been trialled in older children as a non-pharmacological method to reduce pain by the gate control mechanism. This study aims to investigate the efficacy of Buzzy® to reduce pain felt by newborn infants from and heel-prick blood sampling. For this study, only the vibration component will be used. The device will be attached prior to heel prick and activated according to the randomisation arm. Video recording of the entire event pre, during and post procedure for a total duration of 10min, will be taken and assessed by experts blinded to the intervention for documenting pain scores and analysing the difference if any.

This study aims to investigate whether 3D printed patient-matched intranasal splints are effective in improving outcomes of full-thickness skin grafts on nasal oncological defects. Who is it for? You may be eligible for this study if you are an adult patient presenting to the Princess Alexandra Hospital via the Skin Lesion Assessment and Management clinic with a skin cancer localised to the nasal alar requiring surgical excision and reconstruction with a full thickness skin graft. Study details Participants will be randomly allocated to either receive 3D printed splints in their nostrils immediately post-operatively which will be changed daily for 10 days, or an intranasal merocel pack which will be inserted post-operatively and remain in place for 7 days, or no intranasal dressing. Participants will be asked to complete questionnaires on aesthetic and functional outcomes of surgery for up to 45 days post-operatively. It is hoped that findings from this study will contribute to new methods of improving rates of graft take on the nasal alar in patients with skin cancer causing nasal defects.

Delirium is a transient and fluctuating cause of cerebral dysfunction and manifests with a wide range of cognitive and behavioural abnormalities. Delirium is associated with both increased morbidity and mortality and is a medical emergency. The sequelae of delirium are multiple and significant and extend well beyond the acute hospital stay. Delirium is associated with higher rates of death, medical complications, longer hospital stays, functional and cognitive decline and admission to residential aged care facilities. There are no registered pharmacological agents for the prevention or management of delirium. Pharmacological management is currently focused on symptomatic control with antipsychotics, as thus far, the cerebral abnormalities causing delirium have been poorly elucidated. We hypothesise that intranasal insulin, via its neuromodulatory effects, will reduce the rate of delirium leading to improved outcomes for patients and decreased costs of patient care in hospital. This RCT aims to evaluate the use of short-acting intranasal insulin in the prevention of delirium in patients undergoing orthopaedic surgery for femoral fractures. We will also assess the effect of intranasal insulin on duration and severity of delirium, acute and total hospital length of stay, complications, new residential aged care facility placement, cognitive decline, new onset of dementia, mortality, function, cost of care, quality of life (QoL) and emotional/mental impact on patients and caregivers.

Systane Hydration is a lubricating eye drop with unique features and ingredients that may support corneal healing and reduce ocular surface inflammation. This project aims to investigate whether eye drops containing hyaluronic acid and hydroxypropyl guar improve the rate of corneal healing following transepithelial photorefractive keratectomy (tPRK) laser eye surgery, compared to standard carboxymethylcellulose drops. Secondary aims include evaluating the impact of the eye drops on vision and patient-reported comfort levels using a modified dry eye symptom scale. tPRK is an ideal model for assessing corneal healing, as a standard-sized epithelial defect is created in each eye during laser ablation. This controlled setting enables consistent comparison of healing outcomes between treatment groups.

The GLOW Trial is a randomised, double-blind, placebo-controlled feasibility trial of enema-delivered faecal microbiome transplant for Long COVID. This trial aims to test the feasibility of a clinical trial protocol of enema-delivered faecal microbiome transplantation (FMT) in adults living with Long COVID.

Eating disorders are highly disabling and have a high mortality rate (Treasure et al., 2020). Clients referred to community mental health services with an eating disorder can wait for 6-12 months to access specialist treatment. Long waitlists have been linked to poorer treatment outcomes, such as increased dropout rates (Carter et al., 2012). The aim is to evaluate the feasibility of using online self-help modules developed by the eating disorders team at the Centre for Clinical Interventions (CCI) to support people with eating disorders who are currently not receiving treatment. CCI provides free online evidence-informed self-help modules for eating disorders – Break Free from ED (BFED) - which have been accessed over 350,000 times since July 2022. The present research study will evaluate the feasibility of using the BFED modules in a self-help format with minimal guidance in reducing eating disorder and related symptoms.

PrEP STAT is an open-label-two-arm RCT designed to evaluate the uptake of PrEP where Medicare-ineligible MSM receive the intervention—the free PrEP STAT pack (Tenofovir disoproxil fumarate 300 mg and Emtricitabine 200 mg)— compared to those who receive the control —a prescription for PrEP with a PrEP initiation infosheet. Clients will receive either the intervention or control within their consultation at MSHC. This trial will be carried out between June and September 2025. The trial will be integrated into routine care, in which clinicians will be digitally notified (via a message on the client file) when eligible clients visit the centre. Participating clinicians will assess eligibility and invite eligible clients to participate in the PrEP STAT trial.