A Phase 2 Multicentre, Open-label Study to Evaluate the Efficacy, Safety and Tolerability, and Pharmacokinetics of 28 Days Telacebec Treatment in Adult Participants with Buruli Ulcer.

The goal of this interventional clinical trial is to determine if treatment with 4 weeks of telacebac (T) will completely heal lesions in participants with Buruli ulcer (BU) by 52 weeks after treatment initiation, without relapse and/or surgery. Males and females age 18 and older will be included.
* Participants will attend visits every week during treatment (4 weeks)
* Thereafter they will be followed every 2 weeks until week 24 followed by visits as weeks 30, 40 and 52.
* Dependent on site requirements, there may be follow up visits on site or remotely.

开始日期2024-07-09

申办/合作机构

Barwon Health

[+1]

NCT06279260 / RecruitingN/AIIT

National Robotics-Assisted Radical Prostatectomy Database: Exploring Learning Curves and Long Term Surgical, Oncological and Patient Reported Outcome Measures (PROMS)

In Australia, nearly 70 men are diagnosed with Prostate cancer every day. Prostate removal (Radical Prostatectomy) is the proven treatment option to control cancer spread. Most of the prostate removal surgeries are done using robots. Robotic assisted prostate removal surgeries have been invented to minimise the risk of side effects post-surgery. Doctors prefer the robots over open surgery as there are benefits to patients (shorter hospital stays, lesser blood loss and better quality of life) and surgeons (better dexterity, improved field of vision and less pain). However, the cost of the robot outweighs the benefits at present and there is very less information concerning the long-term outcomes for patients.
Studies conducted so far are small scale studies and the results from these studies cannot be generalized to the population at large in Australia. So, there is need for a largescale study that will look at the long-term outcomes and the factors that impact robotic surgeries across the metropolitan and rural hospital sectors.
Hence, this comprehensive database has been setup to collaborate with major hospitals, across metropolitan and rural areas in Australia. Through this database, researchers will be able to explore the diagnostic pathway for Prostate cancer and understand the long-term benefits of robotic surgery through patient reported questionnaires. Outcomes from this database will also help compare the quality of care against other powerhouses of robotic surgery.
Eventually, the database aims to standardize diagnostic pathways and clinical notes that are the same across different hospitals conducting robotic-assisted surgeries for Prostatectomy and improve care for prostate cancer patients across the country.

开始日期2024-07-01

申办/合作机构

Austin Health

[+5]

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项与 Barwon Health 相关的文献（医药）

2024-08-01·Heart, Lung and Circulation

Long-Term Implications of Socioeconomic Status on Major Adverse Cardiovascular, Cerebrovascular Events (MACCE), and All-Cause Mortality

Article

作者: Ganes, Anand ; Williams, Lana J ; Pasco, Julie A ; Hughes, William ; Stuart, Amanda L

BACKGROUNDSocio-economic status (SES) has a large impact on health through a complex interplay of upstream, midstream and downstream factors. However, little is known about the predictive role of SES on long-term major adverse cardiovascular, cerebrovascular events, and mortality (MACCE).AIMTo determine the long-term relationship between SES and MACCE for men and women. The secondary endpoint was to determine the relationship between SES and all-cause mortality.METHODA total of 3,034 participants (1,494 women and 1,540 men) were assessed at baseline in the Geelong Osteoporosis Study, a large regional Australian population cohort study. Area-based SES was assessed, utilising the Index of Relative Socio-Economic Disadvantage (IRSD) and grouped into quintiles. The primary endpoint, MACCE, was defined as a composite of myocardial infarction, heart failure hospitalisation, malignant arrhythmias, stroke, and all-cause mortality. The secondary endpoint was all-cause mortality. Baseline data including age, sex, smoking status and alcohol use, and comorbidities were collected between 1993-1997 for women, and 2001-2006 for men, with follow-up over 30 and 22 years, respectively. Logistic regression was utilised to assess MACCE and all-cause mortality outcomes across the SES quintiles.RESULTSParticipants lost to follow-up or with incomplete data collection were excluded leaving 2,173 participants eligible for analysis. SES was associated with MACCE outcomes. Compared with Quintile I (lowest SES stratum), the odds of MACCE for each IRSD stratum were: Quintile II, odds ratio (OR) 0.85 (95% confidence interval [CI] 0.65-1.13); Quintile III, OR 0.69 (95% CI 0.51-0.91); Quintile IV, OR 0.66 (95% CI 0.50-0.88); and, Quintile V, OR 0.55 (95% CI 0.41-0.72). In the adjusted model, an inverse trend was noted, with reducing MACCE outcomes with an increasing SES status; IRSD Quintile II, OR 0.85 (95% CI 0.62-1.17); Quintile III, OR 0.70 (95% CI 0.50-0.97); Quintile IV, OR 0.73 (95% CI 0.52-1.02); and, Quintile V, OR 0.54 (95% CI 0.39-0.74). SES was inversely associated with all-cause mortality; IRSD Quintile II (OR 0.87, 95% CI 0.66-1.16) failed to achieve significance however IRSD Quintile III (OR 0.65, 95% CI 0.48-0.88), Quintile IV (OR 0.59, 95% CI 0.44-0.80) and Quintile V (OR 0.46, 95% CI 0.34-0.62) had a lower risk of mortality compared with Quintile I. In the adjusted model, an inversely proportional trend was noted between SES and all-cause mortality; IRSD Quintile II (OR 0.82, 95% CI 0.59-1.15), IRSD Quintile III (OR 0.63, 95% CI 0.49-0.95), Quintile IV (OR 0.59, 95% CI 0.45-0.90) and Quintile V (OR 0.44, 95% CI 0.31-0.61) had fewer mortality events compared with IRSD Quintile I.CONCLUSIONSOur research indicates that being part of a lower socio-economic stratum is linked to a higher likelihood of experiencing negative cardiovascular and cerebrovascular events, along with an increased risk of overall mortality. SES is an important risk stratification marker for long-term prognosis of cardiovascular diseases and stroke, and warrants further investigation.

2024-07-01·Journal of Affective Disorders

Psychiatric symptoms, associated pharmacological treatments and cognitive function: A population-based study of men

Article

作者: Sui, Sophia X ; Kavanagh, Bianca E ; Mohebbi, Mohammadreza ; Stuart, Amanda L ; Corney, Kayla B ; Pasco, Julie A ; Williams, Lana J

BACKGROUNDPsychiatric symptomatology and medications used in their treatment may be modifiable risk factors associated with cognitive function, although findings from population-based studies spanning the full adult age range are lacking. This study aimed to investigate associations between psychiatric symptomatology, psychotropic medication use and cognitive function in a population-based sample of men.METHODSData for 537 men were drawn from the Geelong Osteoporosis Study. Cognitive function (psychomotor function, attention, working memory and visual learning) was determined using the Cog-State Brief Battery. Current depressive and anxiety symptomatology was determined using the Hospital Anxiety and Depression Scale, and psychotropic medication use was self-reported. Linear regression models were developed to determine associations between psychiatric symptomatology and psychotropic medication use with each cognitive measure.RESULTSDepressive symptomatology was associated with lower overall cognitive function (b-0.037 ± 0.010, η² = 0.025, p < 0.001), psychomotor function (b 0.006 ± 0.002, η² = 0.028 p < 0.001) and attention (b 0.004 ± 0.001, η² = 0.021, p < 0.001), whereas psychotropic use was associated with lower overall cognitive function (b - 0.174 ± 0.075, η² = 0.010, p = 0.021), attention (b 0.017 ± 0.008, η² = 0.008, p = 0.038 and working memory (b 0.031 ± 0.012, η² = 0.010, p = 0.010). Anticonvulsant use was associated with lower overall cognitive function (b - 0.723 ± 0.172, η² = 0.032, p < 0.001), attention (b 0.065 ± 0.018, η² = 0.029, p < 0.001) and working memory (b 0.088 ± 0.026, η² = 0.022, p < 0.001). All relationships were found to have a small effect. There were no significant associations between anxiety symptomatology and antidepressant and anxiolytic use with any of the cognitive domains.CONCLUSIONDepressive symptomatology and anticonvulsant use were associated with lower cognitive function. Understanding the underlying mechanisms involved in these relationships can advance knowledge on the heterogeneity in cognitive ageing and aid in prevention initiatives.

2024-03-01·Women and Birth

Barriers and enablers to antenatal care attendance for women referred to social work services in a Victorian regional hospital: A qualitative descriptive study

Article

作者: Vasilevski, Vidanka ; Dunn, Matthew ; McKay, Fiona ; Radelaar, Engelina ; Sweet, Linda ; Wright, Marion ; Graham, Kristen ; Vuillermin, Peter J

BACKGROUNDWomen referred to social work services during pregnancy are more likely to experience social disadvantage than those who are not, resulting in reduced antenatal care attendance. Lack of antenatal care engagement leads to poor identification and management of concerns that can have immediate and long-term health consequences for women and their babies. Identifying the barriers and enablers to antenatal care attendance for women referred to social work services is important for designing models of care that promote effective engagement.AIMSThis study aimed to explore the barriers and enablers to antenatal care attendance by women referred to social work services from the perspectives of women, and clinicians who provide antenatal healthcare.METHODSA qualitative descriptive study using constructivist grounded theory methods was undertaken. Ten women referred to social work services and 11 antenatal healthcare providers were purposively recruited for interviews from a regional maternity service in Victoria, Australia.FINDINGSContinuity of care and healthcare providers partnering with women were central to effective engagement with antenatal care services. Three interrelated concepts were identified: 1) experiences of the hospital environment and access to care; 2) perceptions of care influence engagement, and 3) motivations for regularly attending services.CONCLUSIONSContinuity of care is essential for supporting women referred to social work services to attend antenatal appointments. Women are better equipped to overcome other barriers to antenatal service attendance when they have a strong partnership with clinicians involved in their care.

项与 Barwon Health 相关的新闻（医药）

2024-10-10

·GlobeNewswire-Health Care

Recce Pharmaceuticals Announces Recruitment Passes Halfway in Phase II Trial for Acute Bacterial Skin and Skin Structure Infections

Phase II trial assessing the efficacy of RECCE® 327 topical gel (R327G) against acute bacterial skin and skin structure infectionsR327G demonstrating promising antibacterial effect across a broad range of human infectionsClinical study review board on track for mid-October, with interim results to followTrial study locations expand across New South Wales (NSW) and Victoria, broadening access to this potentially novel approach SYDNEY, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd., (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it dosed 15 patients in a Phase II trial evaluating RECCE® 327 topical gel (R327G) in patients with acute bacterial skin and skin structure infections (ABSSSI). ABSSSI includes diabetic foot infections (DFI) and other wound infections – areas of significant unmet medical need. “We are thrilled to pass the halfway point of this pivotal Phase II study for the unmet clinical need of topical skin infections. Indications of promising antibacterial effect are significant achievements, with patient recruitment to be completed within the year,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “The market for ABSSSI is expanding due to an increase in the frequency of bacterial skin infections, particularly those brought on by drug-resistant strains. The acute lack of effective broad-spectrum antimicrobials contributes significantly to this challenge. With our initial data from the Therapeutic Goods Administrations (TGA) Special Access Scheme, which saw dramatic results in several DFI patients, we are excited to complete this trial and the potential of R327G to impact this growing global healthcare need.” R327G has been shown to be safe and well tolerated across subjects, indicating promising antibacterial responses in patients. These initial data represent a significant opportunity to expand the application of R327G’s formulation. ABSSSIs are a significant healthcare concern, with clinical trials addressing indications such as DFIs, necrotizing fasciitis, and post-operative wound infections. The global ABSSSI market size was estimated to be $1.34 billion in 2023 and is expected to reach $2.31 billion in the next 10 years. The Phase II trial is an open-label, pilot efficacy study and exploratory evaluation of the systemic bioavailability of single and/or multiple doses of R327 as a topical gel for ABSSSIs, designed to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area. The study is on track to enroll 30 participants by the end of 2024. In addition to the lead site, Barwon Health, the Company has added two new sites with the Australian Clinical Research Network NSW and ACRN Melbourne. About Recce Pharmaceuticals LtdRecce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens. Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 (R327) as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including their superbug forms; RECCE® 435 (R435) as an orally administered therapy for bacterial infections; and RECCE® 529 (R529) for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics. The World Health Organization (WHO) added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development. Recce wholly owns its automated manufacturing, supporting current clinical trials. Recce’s anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies. Corporate ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 9256 2571James.graham@recce.com.au Media & Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media (USA)Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Investor Relations (USA & EU)Guillame van RenterghemLifeSci Advisorsgvanrenterghem@lifesciadvisors.com

临床2期快速通道合格传染病产品

2022-07-28

·Healthcare IT News

Barwon Health to rollout community EMR next year

Regional health service Barwon Health in Geelong, Victoria is set to implement a community EMR system next year. Based on a media release, the cloud-based EMR system will utilise Salesforce Health Cloud to provide real-time access to clinical information, resources, and appointment times. Its design will also incorporate security and privacy controls. The health service tapped local software integrator Mav3rik to implement the system across Barwon Health's services and Mental Health, Drugs and Alcohol Services (except for the Swanston Centre). WHY IT MATTERS According to Barwon Health, the community EMR is one of the Victorian public health system's first platform-based solutions for community health settings. It is intended to digitise health records for community and mental health patients. "Access to this real-time Barwon Health consumer information will enable clinicians to better respond to each care episode to a level not previously possible in a paper-based health record environment," claimed Barwon Health Chief Information Officer Andrew Macfarlane. "Clinicians will be able to gain access to the full picture of their consumer’s healthcare experience, and consumers will also be able to access their own Barwon Health information," he added. The platform will also allow consumers to have greater control and choice over their health, said Jackie James, Hospital Admission Risk Program community clinician. "The portal will offer an avenue for consumers to access up-to-date information about their healthcare, get valuable health education and resources and communicate with their healthcare providers," she explained. Additionally, the community EMR will help reduce paperwork and provide staff quick access to information while on the road for visitation. THE LARGER TREND Barwon Health has continuously digitised its processes and services in recent years. When the highly-contagious Delta variant caused a new outbreak last year, the health service launched the CovaxApp , a vaccine booking and administration tool, to support its vaccination drive. The app was launched ahead of the rollout of a state-wide online vaccine booking platform by the Victorian government. To have a single source of data that supports real-time analysis, Barwon Health, along with the South West Alliance of Rural Health, implemented InterSystems' IRIS for Health platform to simplify and accelerate the process of extracting value from healthcare data in real-time.

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