ANZCTR search results

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic effects, and exploratory efficacy of AGMG0201 vaccine administered as an intramuscular injection in male and female participants with essential hypertension at two dose levels (low dose; high dose) compared with placebo. You may be eligible to join this study if you are of non-childbearing potential, between 18 and 79 years of age, and have mild to moderate hypertension This is a placebo controlled, dose escalation study. Each participant will receive a single injection to the deltoid muscle, followed by a second injection to the deltoid muscle, in the same arm, 30 days later. A vaccine for hypertension could potentially reduce or halt the use of antihypertensive drugs and reduce long-term medical expenses. Although current antihypertensive drugs appear to fulfill the unmet medical needs of hypertensive patients, there are still serious issues (e.g., daily dosage of the medication, often for life) that may be a significant financial burden, particularly in developing countries.

Indwelling urinary catheters are commonly used in healthcare facilities, with foundation work by two investigators indicating that 26% of patients admitted to an Australian hospital receive an indwelling urinary catheter and 1% of these patients develop catheter-associated urinary tract infections (CAUTIs). Healthcare associated urinary tract infections (HAUTIs), including CAUTIs have been associated with increased morbidity, mortality, higher hospital costs for patients and health systems. In Australia, an estimated 380,000 bed days are lost each year due to HAUTIs, a large proportion of which are CAUTIs. Urinary tract infections (UTIs), specifically CAUTIs are associated with higher risk of antimicrobial resistance (AMR), making the treatment of patients difficult and compounding the effects of AMR when treatment is provided. A recent high-level meeting of the United Nations General Assembly addressed the issue of increasing AMR. This further emphasises the need to develop interventions to reduce the incidence of CAUTIs. Despite advances in infection prevention and control, CAUTIs remain problematic, hence further research is needed to identify ways to reduce the burden they create. The greatest risk factor for CAUTIs is prolonged catheterisation, with catheters often placed unnecessarily, lacking documented reasons for insertion, and catheters remaining in place too long and not being promptly removed. Interventions that prompt removal of unnecessary catheters may therefore enhance patient safety. A reminder intervention is a mechanism used to remind either a physician or nurse that the catheter is still in place and that removal may be warranted if the catheter is no longer required. The current study aims to evaluate the effectiveness of an electronic reminder system – the CATH TAG – to reduce urinary catheter use.

This study aims to determine the maximum tolerated dose (MTD) and assess the efficacy of panitumumab, irinotecan and trifluridine/tipiracil when given in combination for participants with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a confirmed diagnosis of metastatic colorectal cancer that is RAS/BRAF wild type. Study details This study will be conducted in two parts: phase Ib and phase II. The study will commence with a phase Ib dose escalation phase, during which participants will be administered Irinotecan (180mg/m2) and Panitumumab (6mg/Kg) intravenously (IV) on Day 1 of every 14 day cycle, in combination with oral Trifluridine/tipiracil twice a day on Days 1-5 of every 14 day cycle. Dosing of trifluridine/Tipiracil will commence at 25 mg/m2 orally twice a day in the first group. If tolerated, the dose will be elevated for subsequent groups up to a maximum of 35 mg/m2 orally twice a day. Phase II of the study will enrol a separate group of participants who will receive the maximum tolerated dose determined in phase Ib. Treatment in both phases will continue until disease progression, unacceptable toxicity or participant withdrawal. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. Follow-up visits will occur every 12 weeks after the end of treatment visit until death or study closure. It is hoped that this study will provide evidence for further research into this combination, and improve health outcomes for patients with this disease.

Background: Children with chronic health conditions have better health-related outcomes when their care is managed in a personalised and coordinated way. However, increased demand on Australian ambulatory care hospital services has led to longer waitlist times to access specialists and appropriate intervention services; placing vulnerable children at increased risk of poorer short-term (e.g. social difficulties) and long-term (e.g. convictions) health and social outcomes. Traditional approaches to increasing frequency and service of delivery are expensive and can have minimal impact on caregiver burden. A community based service-integration approach, rather than self-directed care is proposed as a better health systems approach, as increased service linkages are more likely to occur thus and improving the health outcomes of children with a chronic health condition resulting in health economic benefits . Aim:To determine the effectiveness of an integrated care pathway led by an allied health liaison officer in the management of chronic disease in children. Methods: An open, unblinded, multi-centre randomised controlled trial in two Australian public hospitals. 112 children (0-16 years) fulfilling the inclusion criteria will be randomised to one of two clinical pathways for management of their chronic health condition: (1) integrated children’s care clinic (ICCC) or (2) self-directed care pathway. All children and caregivers will be interviewed at 1 week, 3, 6 and 12 months time intervals. Primary outcome measures include the Pediatric Quality of Life (PedQOL) questionnaire, subjective units of distress scale, child behaviour checklist (CBCL) and Rotter’s locus of control scale. Secondary outcome measures include the total number of medical appointments, school days missed and quantity of services accessed. Our main objectives are to determine if the ICCC results in better health and economics outcomes compared to the self-directed care pathway. Hypotheses: a) Children who access the ICCC will have improved quality of life (child and family impact) scores than children who access the self-directed care pathway. b) The ICCC pathway is more cost-effective than a self-directed care pathway. Discussion: The success of a health systems approach needs to be balanced against clinical, mortality and cost-effectiveness data for long-term sustainability within a publicly funded health system. A clinical pathway that is sustainable, cost-effective, provides efficient evidence-based care and improves the quality of life outcomes for children with chronic health conditions has the potential to reduce waitlist times to access health services, increase consumer satisfaction; and prevent costs associated with poorly managed chronic health conditions

This is a multicentre, phase 2, randomised, double-blind, placebo-controlled clinical trial with two parallel arms, which will test the effect of GKT137831 200 mg twice a day compared to placebo on urine albumin to creatinine ratio, in adults with type 1 diabetes and persistent albuminuria despite optimal preceding standard of care treatment. We hope to get 92 randomised in order to get 80 people complete treatment. The treatment period is for 48 weeks with total study duration for the participant of up to 56 weeks. There will be 10 study visits. Analyses will include urine albumin: creatinine ratio, HbA1c, renal and liver function, full blood examination, thyroid stimulating hormone, fasting glucose, fasting lipids, pregnancy test if applicable.

One in three older people fall at least once a year and sedentary behaviour (more than 10 hours of inactivity during waking hours) is a risk factor. These dual problems need to be addressed effectively as the ageing population increases. This study is a prospective single-blinded randomized controlled trial (RCT) with a follow-up period of 6 months. This trial aims to establish the feasibility of an individualised goal-setting coaching intervention using feedback from an accelerometer on sedentary time in older people with a recent fall or at risk of one compared to a health advice brochure over 24 weeks. Forty community-dwelling older adults will be randomised to the intervention group and control group respectively. Primary outcomes include feasibility of the intervention and change in sedentary time measured at 12 and 24 weeks after randomisation. Secondary outcomes include falls, fear of falling and walking speed. This trial will address a key gap to evaluate an intervention that could be implemented within the primary health care settings.

Postoperative nausea and vomiting (PONV) is a common complication that may cause significant morbidity. It is usually treated with anti-emetics. Recently, Chewing Gum (GC) showed similar level of efficacy to ondansetron in a pilot controlled trial of surgical patients. Moreover, CG has bee shown to reduce postoperative gut malfunction and vomiting after colorectal surgery However, to date, CG has not bee studied in the prevention of PONV in patients admitted to the intensive care unit (ICU). Thus we aim to perform a study to evaluate the comparative effect of CG compared with the effects of taking a 20 ml sip of water in the prevention of PONV in patients admitted to the ICU after major surgery. Patients will be randomly allocated to be given sugarless plain CG or a 20 ml sip of water 4 hourly for 24 hours. The nurse looking after the patient will record the effects of the intervention on the presence of nausea, its duration, and severity using a visual analogue scale every 4 hours. The number of episodes of vomiting and retching will be recorded. Rescue anti-emetic therapy if the nausea is rated > 5, or if vomiting has occurred. Nausea and vomiting assessments will be made 30 minutes after the patient had been given rescue medication. If the CG intervention proves effective, it will represent an important and easily deployed, safe step towards making the patient's post-operative period less distressing.

Despite advances in management, falls continue to be a major problem for people with Parkinson’s disease (PD). Most falls prevention research excludes people with PD with cognitive impairment; however these are the people most at risk of falls. The objective of this study is to determine the feasibility and acceptability of a multifactorial fall prevention program and assessment for people with PD, including people with impaired cognition and freezing of gait. A mixed methods study with a single group trial of a 4 to 6 month multifactorial home-based fall prevention intervention will be conducted. The intervention will consist of behavioural modification, environmental modification and exercise. The intervention will be delivered by physiotherapists and occupational therapists. Semi-structured interviews will be conducted with participants before and after the intervention. Before the intervention the interview will explore participant’s perceptions of risk and their response to this perceived risk, and after the intervention questions will explore intervention acceptability.

Wernicke-Korsakoff syndrome (WKS) is a neurological disorder caused by thiamine deficiency associated with alcohol dependence or other causes of malnutrition. Although WKS is a common condition, there are currently no universally accepted, national or international, evidence-based guidelines for thiamine dosing for the treatment of either acute symptomatic WKS or for prevention of subclinical WKS-related brain damage in at-risk people. WKS is most commonly seen in alcohol dependent people who therefore constitute a major at-risk population. In the absence of agreed treatment guidelines, different clinical groups or hospital settings tend to maintain their own protocols based on experience or tradition, and in general the dosage levels of thiamine prescribed in Australia for symptomatic WKS varies from lower doses (100-300mg daily) to higher doses (1000mg daily). Australian Department of Health and Aging treatment guidelines recommend 300mg per day for at risk patients (DoHA, 2009). The main aim of this study is to evaluate whether high dose (1000mg daily) thiamine is more effective than Australian standard dose (300mg daily) thiamine for treating subclinical WKS-related brain damage in at-risk alcohol dependent patients admitted for management of their alcohol dependence. The study has direct implications for how this common condition should be treated in the future. In this study, patients will not have acute symptomatic WKS, rather, they will be alcohol dependent patients at risk of subclinical WKS-related brain damage. Patients will be treated as per usual hospital protocols, except that they will be randomly allocated to one of two treatment groups that differ only on dosage amount of thiamine (300mg or 1000mg per day for 3 days) administered via intravenous (IV) infusion. All patients admitted to Depaul House and receiving “treatment as usual” for alcohol withdrawal would routinely have received at least 3 days of thiamine (200mg x two times per day administered intramuscularly) as part of that treatment. Baseline measures, to be obtained before treatment on day 1 and outcome measures obtained after treatment on day 3, include structured examinations of mental health and neurological symptoms, particularly signs associated with WKS such as lack of coordination and irregularity of muscle movement (ataxia) and abnormal eye movements (nystagmus, ophthalmoplegia). Cognitive function will be assessed via standardised tests of working memory and anterograde memory. All participants will receive full hospital care during and after data collection, as per usual hospital protocols for such patients. It was hypothesised that higher doses of parenteral thiamine (1000 mg daily) will lead to greater improvements in specific aspects of cognition and neurological function than lower doses (300mg) in alcohol dependent patients undergoing alcohol withdrawal who are at risk for subclinical WKS-related brain damage.

The primary purpose of this trial is to evaluate the safety and tolerability of A-337, the rate that the drug is processed by the body, and the best dose for treatment in patients with solid tumours. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced malignant solid tumor known to express EpCAM, that does not respond to standard therapy or for which no standard therapy is available. Study details All participants enrolled in this trial will receive eight doses of A-337, delivered twice per week over four weeks. The dose received by each participant depends on the time of their enrolment and the safety of previous doses. A-337 is an antibody designed to target a specific cancer marker, found in some cancers. Researchers will assess patients for side effects of the medication, and take blood samples until 6 weeks after the first dose. It is hoped that the findings from this trial will determined the optimal dose of A-337 to administer for treatment, and to determine whether A-337 is safe and well tolerated by cancer patients.