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Spontaneous bacterial peritonitis or in short ‘SBP’ is a life threatening bacterial infection within the excessive abdominal fluid that accumulates in patients with advanced liver cirrhosis. SBP if discovered or treated late can cause prolonged hospitalisation and even death. The key to treatment of SBP is early detection or prophylactic antibiotic use to prevent its occurrence. It is well known that prophylactic antibiotic use can prevent SBP occurrence but can be associated with side effects of the antibiotics and development of multi-resistant bacteria. Current research to date has limited information on which patients may best benefit from prophylactic antibiotics and there is lack of consensus between experts in this field. The theory behind development of SBP is through the concept called bacterial translocation. The passage of pathogenic bacteria from the inside of the gut through the bowel wall barrier into the gut tissue leads to eventual infective process. One of the key changes that contribute to development of SBP in context of advanced liver cirrhosis is the change that occurs in the gut barrier. Patients with liver cirrhosis have increased permeability or ‘leakiness’ of the gut barrier, thereby allowing pathogenic bacteria to leak across the barrier into the tissue space. This is often compounded by the abnormal overgrowth of pathogenic gut flora in patients with liver cirrhosis. We propose that by determining which patients with liver cirrhosis have highly abnormal gut permeability will allow us to predict who will best benefit from prophylactic antibiotics. We hypothesize that individuals with high gut permeability are most at risk of SBP and would have the most benefit of prophylactic antibiotic use. There has been long standing safe method of measuring gut permeability in children with many different gut disorders since 1980 by measuring two different types of ingested sugars, namely rhmanose and lactulose on a blood or urine test. The test allows measurement of the ingested sugars which crosses the gut barrier into the blood or urine at a set time to determine the functionality of the barrier. The study aims to recruit patients with advanced liver cirrhosis and examine their gut permeability by using this dual sugar test. Subsequently patients with abnormal permeability will be randomised to antibiotics or no antibiotic prophylaxis in a controlled trial to observe its benefit.

This study is being conducted to evaluate the safety, tolerability, pharmacokinetics of ascending multiple doses of XW10172 compared to placebo.

This will be a two part, single-center, randomized, crossover study to investigate the impact of ritonavir co-administration on PRN1008 pharmacokinetics, and to assess the effect of therapeutic and supratherapeutic concentrations of PRN1008 on the QT interval. Participants may enroll in Part A or Part B; participants may not enroll in both Parts. Participants will be screened for this study within 28 day before dosing. Total length of participation in the study for study participants is; Part A, 46 days and Part B 53 days, from study screening through study completion.

Background. Chronic lung allograft dysfunction (CLAD), and especially bronchiolitis obliterans syndrome (BOS), remain dominant causes of morbidity and mortality after lung transplantation. Interest is growing in the forced oscillation technique, of which impulse oscillometry (IOS) is a form, as a tool to improve our understanding of these disorders. However, data remain limited and no longitudinal studies have been published, meaning there is no information regarding any capacity IOS may have for the early detection of CLAD. Methods. We conducted a prospective longitudinal study enrolling a consecutive sample of adult bilateral lung transplant recipients with healthy lung allografts or CLAD and performed ongoing paired IOS and spirometry tests on a clinically determined basis. We assessed for correlations between IOS and spirometry and examined any predictive value either modality may hold for the early detection of BOS. Results. We enrolled 91 patients and conducted testing for 43 mo, collecting 558 analyzable paired IOS and spirometry tests, with a median of 9 tests per subject (interquartile range, 5–12) and a median testing interval of 92 d (interquartile range, 62–161). Statistically significant moderate-to-strong correlations were demonstrated between all IOS parameters and spirometry, except resistance at 20 Hz, which is a proximal airway measure. No predictive value for the early detection of BOS was found for IOS or spirometry. Conclusions. This study presents the first longitudinal data from IOS after lung transplantation and adds considerably to the growing literature, showing unequivocal correlations with spirometry but failing to demonstrate a predictive value for BOS.

CNSA-001 represents the first viable formulation of sepiapterin intended for the treatment of hyperphenylalaninemia (HPA) in PKU patients. This Phase 2 study will assess 2 doses of CNSA-001 in comparison to the maximum recommended dose of Kuvan. This is a proof-of-concept (PoC) study that will help to establish dose selection and support the design of future Phase 2/3 studies in PKU patients.

Children with ASD aged 3 - 5 years old will receive a twice-daily nasally-administered oxytocin or placebo nasal spray for a period of 12-weeks and will also concurrently receive 16 sessions of the Parent-Delivered Early Start Denver Model early learning intervention. Assignment to either the placebo or oxytocin group will be randomised with researchers and participants unaware of treatment group allocation (blinded). Using this double-blinded placebo-controlled between subjects design we hope to identify children with ASD who may benefit from this treatment and the associated cognitive/neurobiological markers that predict these benefits. It is hypothesised that at post-treatment and at three-month follow up, OT treatment combined with P-ESDM will: 1. Improve caregiver-rated social responsiveness as measured by the Pervasive Developmental Disorder Behavior Inventory – Screening Version (PDDBI-SV)

Hypertension does not discriminate; it can affect anyone regardless of age, gender or fitness status. 6 Million Australians (34%) suffer from high blood pressure. Of these, 68% have uncontrolled or unmanaged high blood pressure. This means 4 million Australians are at a greatly increased risk of heart attack or stroke. Out of the 2 million people that are managed, 1 in 3 people measure blood pressure incorrectly at home with current BP monitors. 1 in 3 people have difficulty applying a conventional BP cuff. Tournicare Pty Ltd is developing a BP monitor, Tournicare, that promotes correct placement using only 1 hand. This trial aims to test the safety, accuracy and ease of use of Tournicare compared to a clinically validated home BP monitor. Tournicare will be tested on up to 30 generally healthy participants. Each participant will have their blood pressure measured multiple times over a 15 minute period. The participant will perform successive BP measurements followed coinciding measurements performed by a registered nurse with Tournicare on the left arm and the standard BP monitor on the right arm. The monitors will then switch arms and coinciding measurements will be repeated. During the process the participants will be asked questions regarding usability and user experience.

This is a first in human single-center vaccine study on Dengue Vaccine.The research vaccine is being developed to help protect against a type of virus called dengue virus. Infection with dengue virus can cause a flu-like illness (dengue fever) that sometimes develops into a severe complication (dengue haemorrhagic fever) The study will consist of 3 periods including the Screening Period,Treatment Period and Follow-up Period. After providing the written consent, subject will be screened for eligibility between Day -45 and Day -1. . Approximately 60 participants will participate in this study at one study centre in Australia. All participants will receive two vaccinations, with either the research vaccine or placebo given each time. A placebo is a sterile fluid that has no active vaccine in it. The study consists of 2 parts-Part 1 or Part 2.Participants in Part 1 will receive either low dose research vaccine or placebo. Participants in Part 2 will receive either standard dose research vaccine or placebo.The purpose of this research study is to check whether the research vaccine is safe and how well the subject can tolerate vaccination with the research vaccine (tolerability). The study will also test whether the research vaccine activates an immune response against dengue virus by measuring levels of antibodies (a type of protein involved in the immune response that may protect from future dengue infection) and immune response cells in the blood.

A single centre, open label, sequential dose study to assess the safety and tolerability of two strengths of PA5108 ocular implant in adult who have Open Angle Glaucoma. Participants who are currently administering combination drop therapy for Open Angle Glaucoma will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.

Elevations and excessive fluctuations of intraocular pressure (IOP) are associated with the development and progression of glaucoma. To date, limited research has examined the effect of topical treatments on the patterns of IOP fluctuations in glaucoma patients throughout the course of the day. Access to a novel self-measurement device (Icare HOME), in addition to the research team’s experience in a completed clinical trial and access to an existing glaucoma patient cohort will allow the facilitation of a project which aims to: • Evaluate the effect of topical glaucoma treatments (prostaglandin analogues and beta blockers) on diurnal IOP • Identify glaucoma progression risk in patients with previously undetected, inadequate IOP control • Provide the basis for translational research integrating rebound self-tonometry into clinical protocols for improved glaucoma patient management Results from this study could influence clinical management protocols for glaucoma patients and suspects. Identification of diurnal IOP-related risk factors for disease progression could help clinicians manage at-risk patients appropriately to prevent irreversible vision loss.