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Antibiotics treat infections by killing bacteria. Antibiotic resistance occurs when an antibiotic has lost its ability to kill the bacteria; the bacteria has become resistant to the antibiotic and continues to multiply. One of the main reasons antibiotics lose their effectiveness is we take antibiotics when we don’t need them. Most antibiotics are prescribed for respiratory tract infections, in the community, that often get better without the need for medical intervention. There are many strategies to help doctors and patients to reduce antibiotic use in the community. One of these strategies is called ‘delayed prescribing’. Delayed prescribing, also called ‘wait-and-see prescribing’, is the process whereby a general practitioner (GP) makes available an antibiotic prescription during the consultation, but asks the patient to delay its use to see if symptoms will resolve first. This has been used in other countries very successfully but has never been trialed in Australia. The GP4DP trial wants to test if delayed prescribing can help reduce antibiotic use in community for people who present to their GP with respiratory tract infections. This trial will ask GPs not to prescribe antibiotics unnecessarily and if they do think it might be necessary, to ask the patient to wait and see if the illness will get better on its own before taking the antibiotic. Other studies have shown that most people do wait before taking the antibiotics, complications are extremely rare and the amount of people who present to the Emergency Department does not increase.

This is a single blinded randomised placebo-controlled study. This study will be performed in healthy subjects to determine the pharmacokinetic, safety and tolerability characteristics of a novel Cannabidiol formulation in the form of an oro-buccal spray. The drug contains 6 mg CBD and <0.3 mg other cannabinoids (including THC)/0.3 mL in 2 actuations of the pump (equals 1 dose).

There is a limited number of strong pain relieving medications available for children. All have their own advantages and dis-advantages. For example, anti-inflammatories, like ibuprofen, are unsuitable for those with a bleeding risk and can cause kidney damage. Morphine like drugs come with the risk of slowing breathing and a fear of diversion for illegal use. Tramadol is a medicine that has been used safely for many years in both adults and children. Its advantage is that is has similar pain relieving power to morphine like drugs in the typical dose range, but because it works in a different way, it has much less ability to impair breathing. Its main disadvantage in children is that the drug itself tastes very bitter. In adults, this is overcome by presenting the medication in capsules, so the drug is not released until it reaches the stomach. While there are some 82 registered products in Australia containing tramadol, none of them are licenced for use in children. To provide a suitable dose to small child, the standard adult dose capsule must be broken open, the drug dissolved in water, and the correct proportion given. This is cumbersome for parents, risks error in dosing and produces a horrible tasting solution that most children dislike. There is one preparation available (although not licensed for use in children) of very concentrated oral drops, 1ml containing 100mg of drug, equal to 2 standard capsules. This is unsuitable for young children because the risk of overdose with such a concentrated solution is great, and has occurred with this formulation. To make drugs more palatable to young children they are often dissolved in syrup, but this only masks the bitter taste to a degree and often involves adding artificial flavours and sweeteners. The pharmacy department at Princess Margaret hospital (PMH) in partnership with the Anaesthesiology, Pharmacology and Pharmacy Unit at the University of Western Australia has developed a novel chocolate sweet which can be used to mask the taste of bitter drugs. It has already been used successfully for other medications and found to be very acceptable to children. Using this delivery system has also given the ability to deliver a smaller defined dose, not previously available in Australia, which will allow easier and more reliable dosing in smaller children. This study plans to test the chocolate tramadol tablet against the current broken-open capsule method of delivering tramadol in patients following minor to moderate operations at Princess Margaret Hospital. We will compare how the new “tablet” is tolerated, absorbed and if it is an effective pain reliever. Ultimately we hope to develop a new method to deliver tramadol so it can be more easily and safely be given to children.

Inactivity during pregnancy is associated with adverse health and pregnancy related outcomes for the mother and her unborn child. This innovative randomised controlled trial aims to increase physical activity in pregnant women by integrating an already examined eHealth intervention (Fit4Two) into clinical practice. This intervention will provide participants with highly personalised and automated physical activity feedback, endorsed by their practitioner. As such, participants will receive high quality care in a convenient, credible and time efficient manner, whilst placing very little additional burden on practitioners.

The aim of the EXHALE pilot project is to test whether the Personal Activity Intelligence (PAI) e-Health program improves adherence to exercise targets over a twelve month period in people withType 2 Diabetes. Sixty participants with Type 2 Diabetes will be randomised into the PAI e-Health Program or usual care. Those in the intervention group will receive a MIO Fuse wristband, which uses their heart rate to calculate PAI, the goal being to achieve 100PAI per week. Participants will attend group sessions to learn how to use the technology, and how exercise accumulates PAI. The control group will receive standard care from their GP and/or other healthcare providers. The primary outcome will be the ability to accumulate 100 PAI per week over twelve months. In addition, cardiorespiratory fitness, glycemic control and various physical measures will be assessed at baseline and follow-up. It is expected that the PAI e-Health program will be associated with superior adherence to physical activity compared to usual care.

This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for macular oedema secondary to retinal vein occlusion despite regular injections. The study will describe the effectiveness, safety of intravitreal aflibercept and changes in health related quality of life (HRQoL) among these patients.

Fatigue causes a deterioration in cognitive performance that leads to workplace errors, injury and reduced safety. Shift work is a major source of fatigue because it disrupts the timing and duration of sleep opportunities; and therefore night workers are often chronically sleep deprived. Our work shows that 30min naps can be a powerful tool for maintaining performance during conditions of sleep deprivation. Naps can be particularly beneficial for night workers, who are on duty at times when their body rhythms naturally prime them to be asleep. However, napping can also be hazardous. Our studies show that it can have deleterious effects, in particular, `sleep inertia’, the groggy feeling and performance impairment experienced after waking where workers are extremely vulnerable to errors. This is problematic for oncall workers or health care professionals who take naps during extended hours or night shifts, but on waking need to process complex information, or engage in safety critical activities. Our recent systematic review found very few studies have investigated countermeasures that that can be implemented immediately on waking to reduce sleep inertia. Our work with caffeine gum, funded by USA and Australian Army has found it is fast acting (i.e. within 5min). It could therefore be the ideal countermeasure for the sleep inertia associated with night time naps. This study aims to answer two questions: 1. Will 200mg of caffeine (given in gum form) administered upon waking from a 30 min nap at 2:30am prevent sleep inertia when compared to placebo? 2. Will 200mg of caffeine (given in gum form) administered upon waking from a 30 min nap at 2:30am impact daytime recovery sleep between 12 and 6pm?

This project aims to observe the effects of an endoscopic sleeve gastroplasty utilising the overstitch procedure for the treatment of obesity and diabetes which is an increasing problem in our community. During the procedure, a small tube (the endoscope) is inserted through your mouth and passed down your oesophagus into the stomach and proximal small bowel for visual examination of the upper gut by the physician. The endoscope will be removed and provided the endoscopic examination of your upper gut was normal a stitching device (Overstitch, Apollo Endosurgery) will be attached to the endoscope tip. Then the endoscope will be reinserted and used to stitch the walls of the stomach together to create a smaller volume residual stomach in the form of a tube. This usually requires between 3 and 5 stitches to be placed. These stitches will remain in the stomach indefinitely but can potentially be removed if required. This study will also look to assess the following outcomes • Weight loss - assessed via weight on digital scales at each appointment • Health related quality of life as measured by the SF-36v2 • Psychological wellbeing measured by the Hospital Anxiety and Depression Scale • Pancreatic exocrine functional testing as measured by a 13C labeled mixed triglyceride breath test as measured by a 13C labeled mixed triglyceride breath test • Fasting insulin measured via blood assay • Composite secondary outcome measure of cardiopulmonary reserve and exercise capacity measured by a 6 minute walk test • Fasting Blood glucose measured by blood assay • Stool microbiome community profiling will enable characterisation of the bacterial diversity of the gastric and duodenal mucosa-associated microbiome. • Gastric emptying as measured by 13C Octanoid breath test • Liver function measured by non-invasive hepatic elastography. • Body composition assessment as measured by Dual-energy X-ray absorptiometry • Visceral sensitivity as measured by a Standard Nutrient challenge test. • Self reported diet quality as measured by diet history and 24 hour recall • Gastrointestinal This study will enroll 15 obese type 2 diabetic patients (males and females) recruited from the “Obesity clinic” run by the Department of Endocrinology, general practice referrals or on the waiting list for another study HREC/QPAH/15/246. Patients will be followed up for a period of 1 year from the time of procedure and assessed for changes in the above mentioned variables throughout the follow up period. The data will be compared to the study group baseline characteristics and to the results of a currently still ongoing trial conducted at our Department. In this ongoing trial a group of 15 patients underwent a temporary duodenaljejunal bypass sleeve insertion (HREC/QPAH/15/246).

About 20-30% of patients with angina have no obstructive coronary disease on coronary angiogram (NoCAD). Despite no significant obstructive CAD most of these patients continue to experience recurrent chest pain without any definitive diagnosis. Main aim of this study is to investigate patients with angina and NoCAD with a comprehensive invasive coronary and peripheral haemodynamic studies at the time of diagnostic coronary angiogram and to evaluate the prevalence of various vasomotor disorders in these patients. Further we aim to relate the results of testing to outcome by determining the clinical and coronary haemodynamic predictors of recurrent chest pain on one and 12 months follow up.

Current treatments to control damaging immune responses during autoimmunity use broad immunosuppressive drugs associated with undesirable side effects. Alternative strategies to control damaging immune responses are desirable. DEN-181 offers a novel liposomal therapy that does not broadly suppress the immune system, with the associated increased risk of infectious complications, but rather is designed to specifically address the underlying pathology of Rheumatoid Arthritis by re-programming the immune system towards tolerance for improved patient outcomes and minimal side effects. This study is designed to assess the safety and tolerability of a single dose of DEN-181 in Rheumatoid Arthritis patients.