ANZCTR search results

Partnered pharmacist medication charting (PPMC) is a safe and effective model of care which significantly reduces medication errors and length of stay in hospital, ultimately improving patient flow. This study aims to assess whether virtual delivery of this model (VPPMC) in rural/remote NSW can reduce length of stay, among other measures of effectiveness and feasibility, including an economic analysis using incremental cost-effectiveness ratios. Hospitals within Western NSW Local Health District will be approached for recruitment, then randomised to either the intervention (VPPMC) or control (best usual care). Eligible patients must be aged 18 years or over, admitted to a recruited hospital and, for those admitted to intervention sites, clinically reviewed by a pharmacist prior to partnered charting of regular medications and venous thromboembolism prophylaxis. Data generated from this project would provide evidence to support the VPPMC model as a new standard of care, enabling the expansion of clinical pharmacy services to geographically isolated patients. Therefore, the research team is uniquely placed to be the first to examine and evaluate the unique challenges associated with a VPPMC model.

Penicillin allergies are highly prevalent in the healthcare setting and are associated with second-line inferior antibiotics being prescribed. An incorrect penicillin allergy label leads to increased risk of resistant organisms, side effects from second-line antibiotics as well as increased medical costs. The gold standard for penicillin allergy testing is an oral challenge – either direct or following skin testing. What remains unknown is if a single dose is sufficient to determine if the patient has a delayed or unknown timing immune mediated penicillin allergy or if a prolonged oral challenge (5 days or more) is required. The PROSPECTOR pilot trial demonstrated the feasibility and safety of a placebo-controlled trial of single dose penicillin challenge versus prolonged challenge (5-day). PROSPECTOR2 continues from the PROSECTOR pilot trial (ACTRN12623001242617) to assess the superiority of prolonged oral challenge versus single dose challenge for identifying immune-mediated penicillin allergy. The current Drug Allergy Practice Parameters recommend “against the routine use of multiple-day challenges in the evaluation of penicillin allergy”, providing a “strong recommendation” but with “low certainty of evidence”. The European guidelines reviewed the literature of over 6484 patients, demonstrating a 2.3% positive rate following the initial challenge and 5.5% during the varied prolonged challenges. They concluded there is no consensus on a preferred procedure and could not provide a recommendation for or against prolonged challenge. In Europe, a mixture of observational and retrospective studies has suggested that extended challenges ranging from 3 to 10 days may be superior to single dose challenges at excluding delayed immune reactions, however the reported prevalence of delayed reactions is highly variable (5-12% of patients) and many were reliant on patient self-reporting. In a recent retrospective single centre Danish experience of 3,179 low-risk patients, 2.6% were positive on day 1 of challenge and 7.2% on days 3-10. This is in contrast to the North American experience, where delayed prolonged challenges have been associated with low rates of delayed reactions (0-1.8%). Whilst a study of children demonstrated that delayed reactions may occur less than 7 days following a single challenge. Therefore, whilst oral challenge is the well-defined gold standard for penicillin allergo-immunological investigation, limited controlled evidence is available regarding the efficacy of single dose versus prolonged oral challenge.

This study is investigating if low-dose localised radiotherapy (involved-site radiation therapy or “ISRT”) can sometimes activate the immune system to cause shrinkage or even disappearance of disease in other parts of the body, outside of the treated region, in patients with advanced Follicular lymphoma (FL) Patients in this study will receive very low dose radiotherapy to some, but not all, of their known lymphoma disease sites. This trial will systematically explore the potential of low dose ISRT as a single modality to engage anti-tumour immunity in advanced FL through investigating both the frequency and the biology of abscopal regression in FL. It will utilise serial imaging and correlative analyses with serial blood (+/- tissue) samples, to explore the underlying mechanisms that may be responsible for this important phenomenon. Who is it for? This study is open both to patients who have had recurrence of disease after previous treatments, and patients who have slow growing or stable lymphoma that would be otherwise be managed by close observation without any current active therapy. You must be aged 40 and over. Study details All participants will undergo a Positron Emission Tomography (PET)/Computed Tomography (CT) with fluoro-deoxyglucose (FDG) which is a standard type of scan to detect FL. PET scanning is performed by injecting a small amount of radioactive material (called a tracer) into your bloodstream followed by imaging your body by passing you through a PET/CT scanner. As well as standard FDG-PET scans, this study will involve the use of two new PET scan tracers that allow us to see different aspects of the immune system. These tracers are called 89Zr- IAB22M2C and 89Zr-durvalumab respectively. They need 1- 5 days to be taken up in the tumour after injection and therefore PET imaging scans are performed 1-5 days after the tracer is given. PET scanning with 89Zr-IAB22M2C allows CD8+ T lymphocytes to be tracked in the body. CD8 T cells can be involved in killing tumour cells in patients with cancer and there is evidence from laboratory studies that CD8 T cells accumulate in tumours before abscopal regression occurs. The other new tracer, 89Zr-durvalumab, enables a molecule called PD-L1 to be imaged in patients. PD-L1 is a target for Immune Checkpoint Immunotherapy and can be found on some tumour cells and on cells of the immune system. Using these novel PET tracers we hope to increase our understanding of the effects of radiation on immunity in general and on the abscopal effect in particular.

The HSCT-BIOME study aims to promote gut microbiota health prior to conditioning chemotherapy and promote its stability/recovery after HSCT using encapsuled, lyophilised faecal microbiota transplantation (FMT). Who is it for? You may be eligible for this study if you are a male or female over the age of 18 and have been diagnosed with multiple myeloma, leukaemia, lymphoma or another haematological malignancy to be treated with auto-HSCT. Study details Participants in this study will be randomised to receive either encapsulated faecal microbiota transplantation (FMT) or placebo; each given as 2 courses of 36 capsules. The first course starts before chemotherapy, aiming to boost gut microbiota health. You will be given the second course after HSCT, once your immune system has recovered. Participants' bowel function and symptom burden will be assessed daily for 3 weeks after HSCT. Other clinical data, including how long you stay in hospital and the use of other medications to control side effects, will also be collected. Any adverse event will be constantly monitored during intervention until 30 days post FMT. It is hoped that findings from this study will show FMT is safe and effective at reducing HSCT complications.

Rapid Sequence Intubation (RSI) is a high-risk procedure in the emergency department (ED). Patients are routinely preoxygenated (given supplemental oxygen) prior to RSI to prevent hypoxia during intubation. For many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation prior to intubation. The ETO2 gives an objective measurement of preoxygenation efficacy, this is not currently available in most EDs. This trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED.

Both dietary fibre and unsaturated fats are known for their health benefits on cardiovascular health, however, there are a lack of studies evaluating the effects of dietary fibre from whole foods on endothelial function. The purpose of the study is to assess the impact of a high fibre diet compared to a lower carbohydrate, high unsaturated fat diet on endothelial function, as an early indicator of cardiovascular disease risk. Males over 45 years old and females post menopause with a low dietary fibre intake of less than 15 g/day will be randomised to one of two groups: high fibre diet (40 g/day from whole foods - wholegrains, legumes, fruits, vegetables, nuts and seeds), or high unsaturated fat diet (approx. 40% energy intake from fat from whole foods). Participants will be provided with dietetic counselling to adhere to their allocated diet during the first 3 months of the study, with a follow up at 6 months from commencement. A subset of participants will be assessed in the postprandial phase (as a more sensitive marker or metabolic health), where they will be provided with a high fat, high sugar meal and have their endothelial function tested every 2 hours for up to 6 hours at baseline and 3 months. This study may help with the development of clinical practice guidelines for dietitians to provide dietary advice to patients for vascular health. We hypothesise that both diets will improve endothelial function.

The purpose of this study is to assess the feasibility and safety of an exercise program concurrent with immune checkpoint inhibitor (ICI) immunotherapy for people diagnosed with melanoma. Who is it for? You may be eligible for this study if you are a patient aged 18 years or over with a diagnosis of cutaneous melanoma and are scheduled to receive adjuvant immune checkpoint inhibitor immunotherapy treatment. Study details Participants will be randomly allocated to either an exercise intervention, or standard medical care. Participants randomised to the exercise group receive a structured exercise intervention for the duration of their ICI immunotherapy treatment (approximately 12 months). The intervention will involve 3 exercise sessions per week (45-60min per session) involving both supervised and unsupervised exercise sessions. Participants randomised to the control group will receive usual medical care and general exercise advice as per the current exercise oncology guidelines. Participants will be asked to complete a variety of questionnaires, undergo fitness testing, and provide blood samples. It is hoped that findings from this study will inform researchers of the effects of exercise concurrent to ICI immunotherapy, following surgery, for patients with melanoma.

This is a single-arm pilot study, involving 28 individuals with diabetes; aged between 14 and 26 years old, wearing up to four blinded DS5 sensors for a period of 15 days. The DS5 device is a new disposable sensor platform utilising the Enlite 3 sensor technology which provides a longer sensor wear and improved ease of device insertion. The product incorporates an insertion device, a sensor recorder, and sensor flex into a single disposable device. The primary aims of this pilot study will be to assess the feasibility and acceptability of the study protocol, familiarise the team with the study procedures, identify potential logistical difficulties that may arise in the main study, and collect estimates of parameters to inform power calculations for the larger study. Sensor performance will be assessed against the gold standard venous glucose readings generated by the bedside Yellow Springs Instrument (YSI) glucose lactate analyser. Patient visits will be scheduled to ensure observations are equally spread over 10 days for both the hypo- and hyper-glycaemic conditions.

The project aims to continue from a previous exploration. We will implement a feasibility clinical trial/teletrial to 1) determine the impact of having a co-facilitator with lived experience of voice-hearing sharing their experiences as part of the delivery method, on participants’ levels of empathy and 2) explore whether this translates to a change in practice. Workshops will be delivered in regional and remote South Australia and available to health and social care staff and undergraduate health sciences students.

This study aims to investigate if pre-exercise ingestion of whey protein isolate can prevent hypoglycaemia in adults with T1D using automated insulin delivery (AID) during moderate intensity exercise. We will explore this under both 'optimal' conditions (session A) and modified 'sub-optimal' conditions when pre-exercise and exercise conditions are modified (session B and C). We will also investigate in a sub-cohort of individuals the effect whey protein ingestion has on blood glucagon levels during the 'optimal' exercise session and a 'rest' session (session D). We hypothesise that the used of whey protein ingestion will mitigate the risk of hypoglycaemia during moderate intensity exercise in people with T1D.