Medicine

Listed below are a selection of research projects currently active within ISLHD.

Cardiology

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French J, Everett B, Middleton P, Faddy S, Lee A, Norman S, Zaki N, Krishnamoorthy R, Strategic Reperfusion in elderly patients Early After Myocardial Infarction(STREAM)2.
Locations: Illawarra Shoalhaven Local Health District.
External Partners: Western Sydney University, Liverpool Hospital, University of New South Wales, University of Sydney, NSW Ambulance.

 In elderly patients aged ≥70yrs with ECGs consistent with an acute STelevation myocardial infarction (STEMI or heart attack), who are ≥60 minutes from a primary percutaneous coronary intervention (PCI or coronary stenting) centre, the efficacy and safety of a strategy of early fibrinolytic therapy (clot dissolving) with halfdose tenecteplase as part of a pharmacoinvasive strategy, will be compared to a strategy of primary PCI, among those attended within 3 hours of onset of symptoms

 

Hillis G, Yong G, McQuillan B, Chow C, Myles P, Marwick T, Selvanayagam J, Danson E, Mackay S, A Randomised Controlled Trial of Early valve replacement in severe ASYmptomatic Aortic Stenosis (EASY-AS).
Locations: Wollongong Hospital.
External Partners: Royal Perth Hospital, University of Western Australia, WA Health East Metropolitan Health Service, Fiona Stanley Hospital, The Mount Hospital, Sir Charles Gardiner Hospital, The University of Sydney, The Alfred Hospital, Baker Heart and Diabetes Institute, Flinders University, Flinders Medical Centre.

Aortic stenosis (AS) is a common life-threatening condition in which one of the heart valves becomes narrowed over time. People with severe AS take years to develop symptoms, including shortness of breath, chest pain, or even sudden death. Some patients may never develop symptoms. Heart surgery is a good treatment for symptomatic patients but can cause complications and lead to prolonged recovery. The dilemma is: should we operate in everyone with severe AS to avoid the risk of heart failure and death or wait until symptoms develop to spare patients of unnecessary surgery? This study will reveal whether patients with severe AS but no symptoms are better managed by early valve replacement rather than waiting for symptom development and which strategy is more cost effective.

 

Krishnamoorthy R, Norman S, Mohd Zaki I, Lee A, Shetty P, Elison B, Diagnostic utility of paired myocardial perfusion scans and coronary calcium score in low to intermediate risk chest pain.
Locations: Wollongong Hospital.

Myocardial perfusion studies (MPS) and coronary artery calcium scores (CACS) have been widely utilised non-invasive modalities in the assessment of patients with intermediate risk chest pain. Whilst CACS correlates to burden to atherosclerotic disease, MPS is beneficial in assessing myocardial function and ischaemia. The combination of both modalities can be valuable in risk stratifying patients in the low to intermediate risk in order to appropriately refer higher risk patients for more invasive coronary investigation.

 

Lee A, Mackay S, Norman S, Zaki N, Krishnamoorthy R, Cardiovascular COVID-19 Database.
Locations: Wollongong Hospital.

 

McLean C, Sepahpour A, VT/VT Presentations to Wollongong Hospital - A retrospective study of patient details on presentation and prognosis/outcome.
Locations: Wollongong Hospital.

Out of Hospital Cardiac Arrest is a common presentation for individuals who have Ventricular Tachycardia or Ventricular Fibrillation. At present there is very little evidence to guide initial treatment given the heterogeneous nature of individuals. The main management options are interventional (ICD, EPS, PCI, CABG) or pharmacological. The aim of this research is to identify patient characteristics on presentation that can be used to guide specific management early in their admission.

 

Ooi S-Y, Lovell N, Shetty P, Vaughan B, Mackay S, Norman S, Moragues J, Mohd Zaki NI, TeleClinical Care Cardiac: Efficacy and safety of adjunctive virtual models of care in the secondary prevention of cardiovascular events.
Locations: Wollongong Hospital.
External Partners: The University of New South Wales, Prince of Wales Hospital, St George Hospital, Royal North Shore Hospital, Coffs Harbour Health Campus, Port Macquarie Base Hospital, Liverpool Hospital, St Vincent's Hospital Sydney, The George Institute for Global Health.

The TeleClinical Care (TCC) Cardiac Study is a multi-centre, pragmatic, open-label interventional study designed to examine the comparative effectiveness of a novel telehealth smartphone application  in patients who have recently been discharged from hospital after experiencing an acute cardiac event. The primary objective of this study will be  to determine if use of this system as an adjunct to usual care will decrease the rate of hospital readmission, as well as improve patient quality life and reduce repeated cardiac events by targeting risk factors. Patients are allocated to one of three cohorts and the characteristics of each cohort will be examined in a secondary analysis to examine whether specific risk factors predicate the magnitude of benefit associated with the various levels of the intervention. 

 

Ooi S-Y, Jorm L, Blake V, Mordaunt D, Lee A, Cardiac Analytics and Innovation (Cardiac AI) Research Repository.
Locations: Illawarra Shoalhaven Local Health District.
External Partners: Prince of Wales Hospital, The University of New South Wales, Eastern Heart Clinic.

This project aims to establish a cardiac research data repository of hospital electronic medical record (EMR) data that is linked to other state and national health data sets in order to produce a comprehensive and robust cardiac data set that will allow advanced analytics such as machine learning to improve patient care and outcomes.

 

Patel S, Celermajer D, Keech A, Sullivan D, Vaidya K, Jacob J, Lee A, Norman S, Zaki N, Shetty P, The COLCARDIO-ACS Study - Colchicine Cardiovascular Outcomes in Acute Coronary Syndrome Study - A randomised clinical trial.
Locations: Wollongong Hospital.
External Partners: Royal Prince Alfred Hospital, The University of Sydney, NHMRC Clinical Trials Centre.

The aim of this study is to assess the effect of long-term, low-dose, regular Colchicine plus optimal medical therapy (OMT) versus placebo plus OMT, in patients post-Acute Coronary Syndrome (ACS) with biochemical markers of persistent coronary inflammation, measured 4 to 6 weeks after the ACS event if the patient has been discharged from an acute hospital ward.

 

Shetty P, Jaffar N, Shaw L, Elison B, Mohd Zaki N, Lee A, Norman S, Clingan E, Swainson I, Shen L, Chan L, Gray B, Diagnostic utility of paired myocardial perfusion scans and coronary calcium score in low to intermediate risk chest pain.
Locations: Wollongong Hospital.

This is a registry-style database of assessing paired utility of myocardial perfusion study (MPS) or heart stress test and coronary artery calcium scores or the burden of atherosclerotic plaques in blood supply of the heart (CACS) together with cardiovascular risk factors in predicting significant coronary artery disease or incidence of major cardiovascular events in 1-, 3- and 5-years. 

Endocrinology & Diabetes

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Bergman P, Selvaraj G, Jeyachanthiran K, Martin M, Nicholls N, Australasian Diabetes Data Network (ADDN).
Locations: Illawarra Shoalhaven Local Health District.
External Partners: Monash Health, John Hunter Children's Hospital, The Children's Hospital at Westmead, St George Hospital, Westmead Hospital, Blacktown and Mt Druitt Hospital, Bankstown-Lidcombe Hospital, Liverpool Hospital, Campbelltown Hospital, Queensland Children's Hospital, Mater Hospital Brisbane, Ipwich Hospital, The Women's and Children's Hospital SA, Lyell McEwin & Modbury Hospitals, Flinders Medical Centre, The Royal Melbourne Hospital, St Vincent's Hospital Melbourne, Western Health & Sunshine Hospital, The Royal Children's Hospital Melbourne, Barwon Health, Ballarat Health, Bendigo Health, Peninsula Health, Perth Children's Hospital, Fiona Stanley Hospital, Canberra Hospital, Tasmania North West Regional Hospitals, Monash Children's Hospital.

ADDN provides a secure and centralised data repository for the collection of longitudinal demographic and clinical data for people with diabetes from diabetes centres across Australia and New Zealand. 

 

Francois M, Moses R, Postmeal Walking to Improve Glycaemic Control in Gestational Diabetes
Locations: Illawarra Shoalhaven Diabetes Service.
External Partners: University of Wollongong.

This project seeks to determine the feasibility and effectiveness of postmeal walking exercise to control blood glucose in gestational diabetes.

 

Francois M, Moses R, Should an evening snack be recommended in the management of gestational diabetes.
Locations: Illawarra Diabetes Service.
External Partners: University of Wollongong, Illawarra Health and Medical Research Institute.

GDM, glucose intolerance in pregnancy, is the fastest growing diabetes subtype in Australia. Currently, high fasting glucose (FBG) is of high concern, with more women being diagnosed with elevated FBG increasing the need for exogenous insulin and complications for both mother and child. Despite popular advice from health care practitioners to consume a bedtime snack containing 1-2 carbohydrate exchanges, no scientific studies exist to support this recommendation as a strategy to lower FBG. The research will test whether consuming a snack prior to bed is a viable treatment option for improving fasting and nocturnal hyperglycaemia in women with Gestational Diabetes (GDM).

 

Francois M, Russel B, Moses R, Chang C, Preventing Cardiovascular Disease in Type 2 Diabetes: When is the Right Time to Move?
Locations: Illawarra Shoalhaven Local Health District.
External Partners: University of Wollongong.

High blood glucose after meals (Postprandial hyperglycaemia (PPH)) is an independent risk factor for cardiovascular disease (CVD). Yet there are no specific guidelines for the treatment of PPH. Physical activity (i.e., muscle contractions) stimulates glucose uptake into muscle independent of the hormone insulin. The proposed research will test the novel hypothesis that prescribing physical activity ‘as personalised medicine’ at the time of peak PPH, using continuous glucose monitoring, will reduce risk factors for CVD.

 

Francois M, Bastian B, Smithers L, Webb A, Exploring the effectiveness of insulin therapy in preventing maternal and neonatal adverse outcomes in women with Gestational Diabetes Mellitus (GDM).
Locations: Illawarra Shoalhaven Local Health District.
External Partners: University of Wollongong.

This project will analyse data from women diagnosed with diabetes in pregnancy from 2013-2019 to compare mother and baby outcomes from women treated with insulin compared to diet. Factors such as body mass index (weight vs height), age, weeks at diagnosis and weeks when insulin treatment was started will also be compared.

 

Gilet A, Martin M, Kennedy M, Natrass N, Pape A, Sullivan E, Meditation in Gestational Diabetes Mellitus (GDM).
Locations: Illawarra Shoalhaven Local Health District Ambulatory and Primary Care Services.

This project aims to explore the effects that a daily practice of meditation has on glucose levels in women with gestational diabetes.  Quality of life measures such as stress, anxiety and feelings of well-being will also be recorded

 

MacIsaac R, Isbel N, Ekinci E, Simpson R, Pape A, Reutens A, Vora P, Stranks S, Moses R, Webb A, Nattrass N, Apostoloski Z, A Phase 2b, Multicentre, Randomised, Double-Blind, Placebo-controlled, and Open-label Comparator Study of Cotadutide in Participants Who have Chronic Kidney Disease.
Locations: Illawarra Shoalhaven Local Health District.
External Partners: St Vincent's Hospital (Melbourne), Austin Health, Princess Alexandra Hospital, Southern Adelaide Diabetes and Endocrine Services, Box Hill Hospital, Baker Heart and Diabetes Institute, Alfred Health.

Chronic kidney disease (CKD) leads to progressive decline of renal function and arises due to a combination of age-related decline in renal function exacerbated by conditions such as diabetes mellitus, hypertension, obesity, and primary renal disorders . The global prevalence of CKD is approximately 11-13% and is increasing in parallel with aging populations and escalating prevalence of type 2 diabetes mellitus (T2DM) and obesity. Because dedicated treatments for CKD with T2DM are limited, a large unmet need exists for this patient group. This Phase 2b study is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic (PK) profile of cotadutide at different dose levels in participants who have CKD with T2DM.

 

McCarthy S, Simpson R, d'Emden MC, Howes L, Ekinci E, Caterson I, Williams K, Sangla K, Davis T, Stranks S, Judkins C, Pape A, Worthley M, Nicholls S, Moses R, Apostoloski Z, Luttrell M, van Gemert T, Webb A, Nattrass N, The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT).
Locations: Illawarra Shoalhaven Local Health District.
External Partners: University Hospital Geelong, Fremantle Hospital, Royal Brisbane and Women's Hospital, Gold Coast University Hospital, The Townsville Hospital, Heidelberg Repatriation Hospital, Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders, Nepean Family Metabolic Health Service, Fiona Stanley Hospital, Eastern Clinical Research Unit (Box Hill), Marion GP Plus Health Care Centre, Royal Adelaide Hospital, Monash Cardiovascular Research Centre.

The aim of this study is to compare the effect of tirzapetide versus dulaglutide, measured by effect on cardiovascular outcomes, when added to the standard of care in type 2 diabetes mellitus (T2DM) patients with established cardiovascular disease (CVD) and elevated risk for major adverse cardiovascular events (MACE).

 

Moses R, Pape A, A Randomised, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycaemic Control in Patients with Type 2 Diabetes on Metformin with or without a Sulphonylurea.
Locations: Illawarra Shoalhaven Diabetes Service.

Study GPHO is a phase 3, multicenter, randomized, open-label, parallel-group study to compare the efficacy and safety of 3 maintenance doses of tirzepatide with titrated insulin glargine in patients with T2DM who have inadequate glycemic control on stable doses of metformin +/- sulfonylurea. This study will compare the efficacy and safety of tirzepatide versus titrated insulin glargine in the treatment of T2DM.

Forensic Medicine

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Bilton L, Green H, l'Ons B, Application of 3D Printing in Post Mortem Reconstruction.
Locations: Wollongong Hospital.
External Partners: NSW Health Pathology, Western Sydney University.

This project plans to study the possibilities of advancing existing reconstruction techniques with the use of artificial prosthetics manufactured by 3D printing. Although there are currently several reconstructive approaches, few of them involve the restoration of fractured craniofacial structures as the foundation for the soft tissue reconstruction. In addition, current reconstruction techniques lack structure and stability in situations requiring replacement of vertebrae or skull repair after brain and spinal cord retrievals. The success of this project would substantially increase the likelihood of family viewings where there is significant craniofacial trauma (head and facial trauma) or following the removal of tissue (eg cervical spine) for forensic examination. It would also significantly minimise the trauma and grief process at such devasting times for families.

Gastroenterology

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Ding JNS, Connor S, Begun J, Moore G, Mountifield R, Gan LT, Pierce C, Leong R, Fon JTK, Holman R, Holtmann G, Keegan D, De Cruz P-P, Lee T, Leighton C, Robinson S, Rogge C, A Phase 3, multicentre, randomized, double blind placebo controlled study of oral ozanimod as maintenance therapy for moderately to severely active Crohn's disease.
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital (Melbourne), Liverpool Hospital, Mater Adult Hospital, Monash Health, Flinders Medical Centre, John Hunter Hospital, Fiona Stanley Hospital, Concord Repatriation General Hospital, The Queen Elizabeth Hospital, Royal Adelaide Hospital, Princess Alexandra Hospital, Nepean Hospital, Austin Hospital, .

Crohn’s disease (CD) is an inflammatory disease of the gastrointestinal (GI). Subjects with CD suffer from diarrhoea, rectal bleeding, weight loss, abdominal pain and fever. This is a study to determine the effect of oral ozanimod as a maintenance treatment for subjects with moderately to severely active CD. 

 

Ding JNS, Connor S, Begun J, Moore G, Mountifield R, Gan LT, Pierce C, Leong R, Fon JTK, Holman R, Holtmann G, Keegan D, De Cruz P-P, Lee T, Leighton C, Robinson S, Rogge C, A Phase 3, multicenter, open label study of oral ozanimod for moderately to severely active Crohn's disease.
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital (Melbourne), Liverpool Hospital, Mater Adult Hospital, Monash Health, Flinders Medical Centre, John Hunter Hospital, Fiona Stanley Hospital, Concord Repatriation General Hospital, The Queen Elizabeth Hospital, Royal Adelaide Hospital, Princess Alexandra Hospital, Nepean Hospital, Austin Hospital.

Crohn’s disease (CD) is an inflammatory disease of the gastrointestinal (GI). Subjects with CD suffer from diarrhoea, rectal bleeding, weight loss, abdominal pain, fever. The current standard of care therapy consists of anti-inflammatory approaches. There remains considerable unmet medical need for safe, effective, and oral treatments for CD. This is an open-label, multicenter extension study to evaluate safety and efficacy of ozanimod in subjects with moderately to severely active CD.

 

Ha T, Kapur A, McDonald J, Feletto E, Eckermann S, Simpson H, Bowel Cancer - time for targeting more effective screening strategies in those who benefit.
Locations: Wollongong Hospital.
External Partners: Cancer Council NSW, University of Wollongong.

The main aim of this study is to identify why colorectal cancer (CRC) and pre-cancerous lesions (adenomas and polyps) do not participate in screening and to begin to identify strategies to improve the current nationally funded and administered screening program in Australia (The National Bowel Cancer Screening Program; NBCSP).

 

Hold G, Lee T, Rogge C, Roberts J, Robinson S, et al., Defining the Australian Inflammatory Bowel Disease Microbiome - the AIM Study.
Locations: Wollongong Hospital.

The aim of this study is to better understand the microbial and host cellular events underlying the development of inflammatory bowel disease (IBD). Our aim is to define the changes in the gut microbiota and host response which occur prior to, during and after to IBD symptoms. Our experimental approach uses a multi-analysis approach strategy to allow us to understand how changes in the host response interplay with changes in the gut microbiota. Through understanding more fully the sequence of events which precedes IBD symptom onset we will be able to more effectively manage existing IBD patients and their disease but more exciting, ultimately to potentially prevent people from developing the disease.

 

Leong RWL, Andrews JM, De Cruz P-P, Holtmann J, Keegan D, Pearce CB, Fon JTK, Lee T, Leighton C, Robinson S, Induction Study #1 - A phase 3, multicenter, randomized, double blind, placebo controlled study of oral ozanimod as induction therapy for moderately to severely active Crohn's Disease.
Locations: Wollongong Hospital.
External Partners: Concord Repatriation General Hospital, Royal Adelaide Hospital, Austin Hospital, Princess Alexandra Hospital, Nepean Hospital, Fiona Stanley Hospital, Queen Elizabeth Hospital.

This is a Phase 3, randomized, double-blind, placebo-controlled study to determine the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease. Approximately 600 subjects with active clinical symptoms and mucosal inflammation will be randomized in a 2:1 ratio to receive either ozanimod or placebo. Subjects will be stratified by prior biologic use (yes/no) and corticosteroid use at baseline (yes/no).

 

Moore G, Rogge C, Lee T, Robinson S, Leighton C, A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease who have failed anti-TNF therapy.
Locations: Wollongong Hospital.
External Partners: Monash Health.

This study is being conducted to compare the efficacy and safety of risankizumab versus ustekinumab for the treatment of adult subjects with moderate to severe CD who have failed anti-TNF therapy.

 

Nash E, Strasser S, Duong T, Humphris J, Drug-induced liver injury from anabolic-androgenic steroids and selective androgen receptor modulators: an Australian case series.
Locations: Wollongong Hospital.
External Partners: Royal Prince Alfred Hospital, The University of Sydney.

This project will look at the number of people who have had liver damage due to taking anabolic steroids or similar drugs, which are commonly taken as bodybuilding supplements.  It will also look at what tests they had and their outcomes.  

 

Perananthan V, Valiozis I, Early W, Abdominal Computed Tomography (CT) in patients diagnosed with viral and bacterial gastroenteritis: Does CT abdominal imaging alter management? 
Locations: Wollongong Hospital.

This project aims to retrospectively analyse patients diagnosed with gastroenteritis, and evaluate those who received abdominal CT scans, and whether having this scan changed management, increased length of stay, resulted in endoscopic intervention, whether endoscopic intervention changed management, and whether there was an increased risk of CT-related complications.

 

Thompson A, Valiozis I, Lucas M, Hepatitis C DAA treatment failure with corresponding baseline and end-of-treatment HCV viral variants for resistance.
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital Melbourne.

This both a retrospective and prospective observational study that will assess the prevalence of resistance-associated substitutions (RAS) within the Hepatitis C (HCV) genome of chronically infected patient, including a subset who have failed direct acting antiviral (DAA) therapy. Multiple other Australian hospitals will also contribute deidentified data regarding their patients treated with Sofosbuvir, Velpatasvir and Voxilaprevir via an Australian wide extended access program to determine the efficacy and safety of this salvage regimen in real world settings. Baseline characteristic and investigational results at end of treatment and cure will be recorded to identify determinants of successful treatment.

Infectious Diseases

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Davis J, Sud A, Dotel R, O'Sullivan M, Foo H, Ghosh N, McKew G, Gray T, Paterson D, Smith S, Holmes N, Rogers B, Robinson JO, Davies J, Aganostou N, Runnegar N, Tramontana A, Morton M, Impact of evidence-based quality-of-care processes gained from clinical trial participation on management and outcome of methicillin-resistant Staphylococcus aureus bacteraemia (CAMERA2 case-control retrospective study).
Locations: Wollongong Hospital.
External Partners: John Hunter Hospital, Menzies School of Health Research, Nepean Hospital, The University of Sydney, Blacktown Hospital, Westmead Hospital, University of Melbourne, Liverpool Hospital, Concord Repatriation General Hospital, University of Queensland, Royal Brisbane and Women's Hospital, Cairns Hospital, Austin Health, Monash University, Monash Medical Centre, Royal Perth Hospital, Royal Darwin Hospital, Flinders Medical Centre, Princess Alexandra Hospital, Western Health.

This retrospective case-control study aims  to compare clinical outcomes (i.e. mortality) and adherence to quality-of-care processes (QCPs; e.g. follow-up blood cultures, echocardiography, infectious disease specialist consultation, etc) between clinical trial participants (cases) versus non-clinical-trial patients (controls). The cases will be participants of our recently concluded Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus infection (CAMERA 2) trial. The controls will be Methicillin Resistant Staphylococcus aureus (MRSA) bacteraemia patients from CAMERA2 sites NOT enrolled into the CAMERA2 trial. We hypothesise that CAMERA2 participants have better outcomes compared with controls due to improved adherence to QCPs.

 

Ghosh N, Fernandez L, Jones A, Newton P, Handley B, Cuenca J, Epidemiology, Clinical Characteristics and Pulmonary Function Status of Patients Recovered from SARS-CoV-2 Infection.
Locations: Wollongong Hospital.

The primary aim of this project is to define the long term clinical impact of COVID-19 on respiratory function. In addition, we will assess the impact of SARS-CoV-2 infection on patients’ psychosocial and functional status.

 

Shehabi Y, Rogers B, Leditschke A, Nayyar V, Sarode V, Rudham S, Chimunda T, Finfer S, Taori G, Udy A, Moore J, White H, Dwivedi D, Shum O, Eyles M, Miyakis S, Stockbridge R, Arcioni S, Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: Randomized Controlled Trial - the BALANCE study.
Locations: Wollongong Hospital.
External Partners: Monash Health, Mater Private Hospital, Westmead Hospital, Cabrini Hospital, St Vincent's Hospital (Melbourne), Bendigo Health, Royal North Shore Hospital, Dandenong Hospital, Alfred Hospital, Sunshine Coast University Hospital, Logan Hospital.

The optimal duration of antibiotic treatment for critically ill patients with bloodstream infections is unknown. There is evidence in less severe infections that shorter durations of antibiotic treatment are as equally effective as longer durations of treatment. There is considerable variation in the length of antibiotic treatment doctors prescribe for patients with bloodstream infections, but longer duration contribute to antibiotic resistance, complications such as secondary infections and increased healthcare costs. This international, multicentre, randomized, controlled trial in New Zealand, Canada and Australia involving 3,600 patients in 40 intensive care units will determine whether a shorter duration of antibiotic treatment (7 days) for patients with bloodstream infections is as effective as a longer duration of treatment (14 days) and is associated with less total antimicrobial use, and fewer secondary bowel infections, adverse events and development of antibiotic resistant organisms. The cost effectiveness of total treatment costs under the two alternatives will also be studied.

 

Slavin M, Yong M, Thursky K, Teh B, Worth L, Haeusler G, Reynolds G, Weinkove R, McQuilten Z, Crane M, Shum O, Leighton C, Robinson S, A Multi-Centre National Study of COVID-19 Infection in Cancer Patients.
Locations: Wollongong Hospital.
External Partners: Multiple hospitals Australia-wide.

Since the identification of a novel coronavirus SARS-CoV-2 in January 2020 and its associated respiratory disease, COVID-19 has gained worldwide attention. While most cases result in mild symptoms, a significant proportion of the fifteen percent of patients hospitalised with COVID-19 have additional complications requiring intensive care admission, end-organ support and mechanical ventilation. Cancer patients are vulnerable to many infections and may represent a subgroup of patients disproportionately affected by COVID-19 morbidity and mortality. Currently, the outcomes of COVID-19 infection in cancer patients are yet to be adequately captured yet this population is at high risk of mortality. This National Centre for Infections in Cancer (NCIC)-led project aims to evaluate the clinical course of cancer patients who develop COVID-19 within Australia and New Zealand and will provide critical information about cancer patients’ risks, clinical outcomes and ways to best support cancer patients during public health epidemics. Nuances in potential interaction between cancer therapies, cancer immunity and treatments for COVID-19 may better inform management of COVID-19 infection amongst this group.

 

Slavin M, Coussement J, Teh B, Chen S, Van Hal S, Beardsley J, Smibert O, Heath C, Morrissey O, Crowe A, Kennedy K, Smith B, Tramontana A, Korman T, Alcorn K, Chean R, O'Kane G, David J, Bartolo C, Bloch A, Mahony A, Cooley L, Roberts M, Lynar S, Crawford S, Pratt W, Presentation, management and outcome of Cryptococcus infections: a multicentre retrospective study focusing on patients without HIV infection.
Locations: Wollongong Hospital.
External Partners: The Royal Melbourne Hospital, Westmead Hospital, Prince of Wales Hospital, Fiona Stanley Hospital, Royal Perth Hospital, The Alfred Hospital, St Vincent's Hospital Melbourne, ACT Pathology, Canberra Health Services, Eastern Health Victoria, Monash Health, Peter MacCallum Cancer Centre, Gosford Hospital, Gold Coast Hospital and Health Service, Royal Prince Alfred Hospital, Western Health Victoria, La Trobe Regional Hospital, Wyong Hospital, University Hospital Geelong, Bendigo Health, NSW Health Pathology, John Hunter Hospital, Ballarat Health Services, Royal Hobart Hospital, Royal Adelaide Hospital, Flinders Medical Centre, Royal Darwin Hospital, Palmerston Hospital, The University of Melbourne.

Cryptococcosis is one of the most common and deadly opportunistic infections in people living with HIV. In medically developed countries, the incidence of cryptococcosis has greatly decreased since the 1990s, following the widespread use of highly active antiretroviral therapy in people living with HIV. In contrast, patients with other forms of immunosuppression are increasingly being recognised as vulnerable to Cryptococcus, including transplant recipients, other patients receiving immunosuppressive therapy, and cancer patients. We would like to conduct a multicentre retrospective study focusing on Cryptoccocus infections in patients without HIV infection, with the intention to describe the epidemiology, presentation, management and outcomes of cryptococcosis in these patients.

 

Sud A, Davis J, Cheng A, Peel T, Tong S, Gilroy N, Patterson D, Gray T, Marriott D, Shum O, Crawford S, Adams N, Eyles M, Vertebral OsteoMyelitis Baseline Assessment and Treatment (VOMBAT).
Locations: Wollongong Hospital.
External Partners: Nepean Hospital, John Hunter Hospital, The Alfred Hospital Melbourne, The Royal Melbourne Hospital, Westmead Hospital, The Royal Brisbane and Women's Hospital, Concord Repatriation General Hospital, St Vincent's Hospital Sydney.

Spinal infection (including vertebral osteomyelitis, discitis and epidural abscess) remains an uncommon condition which is difficult to diagnose but a potentially devastating infectious disease. Delays in diagnosis can lead to death, irreversible neurological deficits and persistent pain. Vertebral osteomyelitis accounts for approximately 2-7% of all cases of osteomyelitis. In recent years a rise in the incidence of pyogenic spinal infection has been reported in many institutions.  Some of the apparent increase in incidence may be due to enhanced detection through improved imaging technology, especially magnetic resonance imaging (MRI). The strength of evidence guiding duration and route of administration of antibiotics is at best moderate; neither is there a standard tool for assessment of response to therapy. This study therefore aims to 1) describe the presentation, diagnostic and management strategies, and outcomes adults with pyogenic vertebral osteomyelitis; and 2) estimate the burden of disease and costs of managing patients presenting with VOM.

 

Tong S, Shum O, Leighton C, Miyakis S, et. al., Australasian COVID-19 Trial (ASCOT).
Locations: Wollongong Hospital.
External Partners: Several hospitals Australia-wide.

There are no therapies known to be effective for COVID-19. Several treatments have shown laboratory activity and are entering clinical trials. Lopinavir/ritonavir (LPV/r) has demonstrated some laboratory activity and is available as an approved oral formulation for HIV. Hydroxychloroquine has demonstrated some laboratory activity and is available as an approved oral formulation for malaria. The ASCOT trial is multi-centre Randomised Clinical Trial to assess clinical, virological and immunological outcomes in hospitalised patients with SARSCoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to current standard of care.

Medical Imaging

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Glenn D, Hewitt L, Seth I, The incidence of head injuries at time of neck of femur fracture and the role of CT brain scans.
Locations: Wollongong Hospital.

This study is looking to determine the incidence of head injuries alongside with neck of femur fractures, including the role that CT brain scans may have as an appropriate investigation for such patients. 

Neurology

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Strathdee J, Venkat A, Lichtenberg I, Impact of COVID-19 on acute stroke admissions and outcomes: A regional Australian hospital experience.
Locations: Wollongong Hospital.

If there is a change in stroke presentations with corresponding worse outcomes, public health campaigns encouraging patients to present earlier to hospital with stroke-like symptoms may be required. This is particularly important as Australia transitions to a post COVID-19 life as viral case numbers drop. At present, there have been no Australian publications on rates of presentation for strokes during COVID-19.

Renal Medicine

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Badve S, Krishnasamy R, Paul-Brent P-A, Hassan HIC, Chen JHC, Shen Y, Phosphate Study.
Locations: Wollongong Hospital.
External Partners: St George Hospital, University of New South Wales, Western Sydney Renal Service, Bundaberg Hospital, Logan Hospital, Mackay Hospital, Princess Alexandra Hospital, Sunshine Coast Hospital and Health Service, Central Northern Adelaide Renal and Transplantation Service, Monash Health.

High phosphate levels are common in patients with End Stage Kidney Disease (ESKD) and are associated with increased risk of death. The international guidelines suggest lowering elevated phosphate levels towards the normal range. However, there is a lack of evidence that phosphate lowering treatments will improve patient-centred outcomes

 

Badve S, Smyth B, Chen JHC, Shen Y, Hassan HIC, The TRACK Trial:  Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced Chronic Kidney disease.
Locations: Wollongong Hospital.
External Partners: The George Institute for Global Health, The University of New South Wales, St George Hospital, Sutherland Hospital.

Investigator-initiated, multi-centre, prospective, double-blind, parallel-group, event-driven, randomised controlled trial (RCT) to assess the effect of low dose rivaroxaban on the risk of cardiovascular (CV) death or major cardiovascular events (MACE) in people with advanced stages of chronic kidney disease (CKD) or end-stage kidney disease (ESKD) receiving dialysis, and CV disease. Patients with CKD stage 4-5 and ESKD receiving dialysis are at significantly increased risk of CV death, myocardial infarction and stroke, but also bleeding.  Unfortunately, RCT-based evidence relevant to any antithrombotic agent, such as rivaroxaban, in this patient population is currently lacking. A recent randomised control trial, the COMPASS trial, showed that low dose rivaroxaban has a favourable benefit:harm balance in patients with mild CKD and stable coronary or peripheral arterial disease. Thus, low dose rivaroxaban is a promising novel cardiovascular disease treatment option for patients with advanced CKD including ESKD.

 

Chen JHC, Mullan J, McAlister B, Ilic N, Kim D, Mitchell H, Renal supportive care in Illawarra Shoalhaven Local Health District: Symptom management and hospital utilisation in patients with advanced chronic kidney disease and end-stage kidney disease on non-dialysis pathway.
Locations: Illawarra Shoalhaven Local Health District.
External Partners: University of Wollongong, Centre for Health Research Illawarra Shoalhaven Population (CHRISP).

The Renal Supportive Care (RSC) service started in Illawarra Shoalhaven Local Health District (ISLHD) in November 2015. There is limited literature available on symptom improvement and hospital utilisation among patients on a non-dialysis pathway managed by RSC service. We aim to examine whether the RSC service improves symptom burden in patients with advanced chronic kidney disease (CKD) and end-stage kidney disease (ESKD) and whether the RSC service has reduced hospital readmission rates and emergency department presentations for ESKD patients on a non-dialysis pathway.

 

Chen JHC, Boudville N, ANZDATA Peritoneal Dialysis Working Group, Temporal trends and peritoneal dialysis outcomes of low GDP peritoneal dialysis solutions in Australia and New Zealand.
Locations: Illawarra Shoalhaven Local Health District.
External Partners: University of Western Australia.

This study aims to examine the association between PD solutions and PD peritonitis, technique failure, all-cause mortality, and cause-specific mortality using ANZDATA registry. The findings from this study will provide more insight into PD prescription in Australia and New Zealand and improve our understanding of the long term clinical outcomes in patients receiving low GDP PD solutions, which may assist clinicians in selecting the appropriate PD solutions and catheters for kidney failure patients on peritoneal dialysis.

 

Currow D, Clark K, Agar M, Lovell M, Chye R, Clayton J, Sanderson C, Chen JHC, Ilic N, Rapid Report Pharmacovigilance Program.
Locations: Wollongong Hospital.
External Partners: University of Technology Sydney, Bankstown Hospital, Braeside Hospital, Calvary Health Care Kogarah, Calvary Mater Newcastle, Camden Hospital, Campbelltown Hospital, Concord Hospital, Greenwich Hospital, Liverpool Hospital, Neringah Hospital, Prince of Wales Hospital, Royal North Shore Hospital, St Vincent's Hospital (Sydney), St Vincent's Private Hospital, Westmead Hospital.

A prospective observational study of palliative and supportive care interventions - understanding the burden of the adverse effects.

 

Hassan HIC, Murali K, Chen JHC, Association between peritonitis and cardiovascular mortality in patients on peritoneal dialysis.
Locations: Illawarra Shoalhaven Local Health District.

In the peritoneal dialysis (PD) population, PD peritonitis remains a challenge for patients and health care providers and remains one of the most common reasons for technique failure. However, the association between peritonitis and cardiovascular events has not been extensively examined in this high-risk population. Three studies which directly addressed this question yielded conflicting results and were limited by methodological issues. Only one registry analysis, from Brazil, showed an increased risk of cardiovascular death following a peritonitis episode. Similarly, a single centre study showed an increased risk of cardiovascular mortality in PD patients following an episode of PD peritonitis. However, a recent ANZDATA study examining technique and patient survival in PD patients showing that <10% of the association between diabetes and cardiovascular mortality was mediated by peritonitis. This study aims to examine the association between peritonitis and cardiovascular mortality in detail using the Australia and New Zealand Dialysis and Transplant (ANZDATA) registry.

 

Hassan HIC, Chen J, Murali K, An ANZDATA study examining peritonitis as a risk factor for cardiovascular mortality along with annual trends of peritonitis episodes and cardiovascular mortality from 2003- 2019.
Locations: Illawarra Shoalhaven Local Health District.

Patients on peritoneal dialysis (PD) are at a high risk of cardiovascular death. An episode of infection is a risk factor of cardiovascular death in this population. Patients on PD are at risk of peritonitis. Studies previously examining the risk of cardiovascular death following a peritonitis episode have been done but were flawed. We previously undertook a study examining peritonitis as a risk factor for cardiovascular death in our Centre, however the result is underpowered. We seek to examine a national dialysis registry (ANZDATA) in order to understand the risk of cardiovascular death following a peritonitis episode in this high risk group. We also aim to examine peritonitis trends annually and see how this compares to cardiovascular mortality trends.

 

Jardine M, Wilcox A, Hockham C, Kotwal S, Chen JHC, Shum O, Shen Y, Facci F, Ralph M, Treatment of COVID-19 Infection with Angiotensin Receptor Blockers, a Randomised-Controlled Evaluation (CARE).
Locations: Wollongong Hospital.
External Partners: Concord Repatriation General Hospital, The George Institute for Global Health, The University of New South Wales, The University of Sydney.

This study aims to investigate whether treatment with angiotensin receptor blockers will reduce the severity of symptoms in people with a positive diagnosis of COVID-19.

 

Lambert K, Ilic N, Chen JHC, Mitchell H, How does pain impact the life of people with severe kidney failure?
Locations: Illawarra Shoalhaven Local Health District.
External Partners: University of Wollongong.

Half the population with end stage kidney disease (ESKD) experience chronic pain. The aim of this project is to explore the lived experience of pain in older people with ESKD from the patient and carer perspective.  The significance of this project is two-fold. First, new insights will enable the development of strategies to reduce pain and improve patient quality of life. Secondly, the multidisciplinary team involved in this research has the capacity to readily facilitate and translate the findings of this study into changes in policy and clinical practice.

 

Pedagogos G, Chen J, Foote C, Badve S, Shen Y, Holt J, A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease.
Locations: Illawarra Shoalhaven Local Health District.
External Partners: Western Health Victoria, Eastern Health Victoria, Concord Repatriation General Hospital, St George Hospital.

This study will investigate the efficacy and safety of finerenone on the progression of non-diabetic chronic kidney disease in comparison to placebo, in addition to standard of care. The main objective is to demonstrate that finerenone in addition to standard of care may delay the progression of kidney disease. The study also aims to explore the changes in chronic eGFR slope decline over time of Finerenone treatment vs Placebo.

Respiratory Medicine

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Jones AC, Maqbool MB, Napaki SM, Optimum volume of pleural fluid required to find immune-cytological and molecular markers among patients of Non-small Cell Lung cancers (NSCLC).
Locations: Wollongong Hospital.

The data available to date is from two studies performed in the United States recommended optimum pleural fluid volume 50 ml and 70 ml for accurate cytological diagnosis of lung cancers. It is unclear whether collection of extra pleural fluid would provide extra cellular material to improve defining molecular and immuno-cytological markers which are now routine in lung cancer management. We aim to determine the optimal volume of pleural fluid that is required to diagnose lung cancer using molecular and immune-cytological markers in a retrospective cohort of patients presenting to the Illawarra Shoalhaven Local Health District.

 

Jones A, Wen K, The Wollongong Hospital Virtually enhanced Respiratory Care with Short Term Oxygen Therapy Pilot Study.
Locations: Wollongong Hospital.

This pilot study aims to shift the last one to two days of a patient's hospital stay into the home setting through the use of virtual care. The study population will be inpatients with exacerbations of chronic obstructive pulmonary disease.  The hospital nursing and interventions will be shifted into the home setting with vital sign monitoring and nursing will be provided through the  virtually enhanced community care service.  Supplemental oxygen therapy (if required) that would be provided in hospital will be provided through oxygen concentrators in the patient's home. The patients will be on medications that they will be able to self administer. The aim of the pilot study is to determine if this management strategy is safe and feasible. It is hypothesized that there will be cost savings to the hospital system by decreased length of hospital stay. 

 

Wark P, Samuel S, Vining L, Choosing between biological agents for severe allergic eosinophilic asthma.
Locations: Wollongong Hospital.
External Partners: University of Newcastle, John Hunter Hospital.

Severe asthma clinicians now have the choice to access treatment with two biologic agents: Omalizumab or Mepolizumab. Clinical trials were designed to maximise their treatment effect against the broadest number of severe asthma patients. They did not compare them to each other in terms of efficacy, nor provide clarity as to who may benefit from one agent compared to the other if either presents as a possible treatment option. The study described here will compare the two monoclonal antibody treatments in severe asthma patients whose asthma presentation qualifies for either treatment according to PBS approval criteria.

Rheumatology

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Loganathan A, Raman A, Riordan J, Evaluating the perceptions of the management of lower back pain.
Locations: Illawarra Shoalhaven Local Health District.

We have designed a questionnaire to be distributed to junior doctors and final year medical students in Australia to understand their perceptions about managing back pain. The questionnaire involves demographic data and ten multiple choice questions based on a hypothetical clinical scenario of a patient with lower back pain.

 

Loganathan A, Siva Das A, Raman A, Naveed A, Riordan J, Concordance of temporal artery biopsy in Giant Cell Arteritis.
Locations: Wollongong Hospital.

The aim of the project is to determine the concordance rate of bilateral temporal artery biopsies in patients with giant cell arteritis. It will be a retrospective review of patients who have had a positive temporal artery biopsy in The Wollongong Hospital, who will be compared to a randomly-selected matched control group who have had negative temporal artery biopsies. From examining this data, will determine the negative predictive value of biopsies and prevalence of medical and surgical complications. 

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