Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters
Estee P. M. Lau,
Matthew Ing,
Sona Vekaria,
Ai Ling Tan,
Chloe Charlesworth,
Edward Fysh,
Ranjan Shrestha,
Elaine L. C. Yap,
Nicola A. Smith,
Benjamin C. H. Kwan,
Tajalli Saghaie,
Bapti Roy,
John Goddard,
Sanjeevan Muruganandan,
Arash Badiei,
Phan Nguyen,
Mohamed Faisal Abdul Hamid,
Vineeth George,
Deirdre Fitzgerald,
Nick Maskell,
David Feller-Kopman,
Kevin Murray,
Aron Chakera,
Y C Gary Lee
Affiliations
Estee P. M. Lau
Pleural Medicine Unit, Institute for Respiratory Health
Matthew Ing
Pleural Medicine Unit, Institute for Respiratory Health
Sona Vekaria
Department of Respiratory Medicine, Sir Charles Gairdner Hospital
Ai Ling Tan
Pleural Medicine Unit, Institute for Respiratory Health
Chloe Charlesworth
Department of Respiratory Medicine, Sir Charles Gairdner Hospital
Edward Fysh
Medical School, Faculty of Health & Medical Sciences, University of Western Australia
Ranjan Shrestha
Department of Respiratory Medicine, Fiona Stanley Hospital
Elaine L. C. Yap
Department of Respiratory Medicine, Middlemore Hospital
Nicola A. Smith
Department of Respiratory Medicine, Wellington Regional Hospital
Benjamin C. H. Kwan
Department of Respiratory and Sleep Medicine, The Sutherland Hospital
Tajalli Saghaie
Department of Respiratory Medicine, Concord Repatriation General Hospital
Bapti Roy
Department of Respiratory and Sleep Medicine, Westmead Hospital
John Goddard
Department of Respiratory Medicine, Sunshine Coast University Hospital
Sanjeevan Muruganandan
Department of Respiratory Medicine, Northern Health
Arash Badiei
Thoracic Medicine, Royal Adelaide Hospital
Phan Nguyen
Thoracic Medicine, Royal Adelaide Hospital
Mohamed Faisal Abdul Hamid
Respiratory Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia
Vineeth George
Department of Respiratory and Sleep Medicine, John Hunter Hospital
Deirdre Fitzgerald
Department of Respiratory Medicine, Tallaght University Hospital
Nick Maskell
Academic Respiratory Unit, Bristol Medical School, University of Bristol
David Feller-Kopman
Department of Medicine, Section of Pulmonary and Critical Care Medicine, Dartmouth-Hitchcock Medical Center
Kevin Murray
School of Population and Global Health, University of Western Australia
Aron Chakera
Renal Unit, Sir Charles Gairdner Hospital
Y C Gary Lee
Pleural Medicine Unit, Institute for Respiratory Health
Abstract Background Malignant pleural effusion (MPE) is a debilitating condition as it commonly causes disabling breathlessness and impairs quality of life (QoL). Indwelling pleural catheter (IPC) offers an effective alternative for the management of MPE. However, IPC-related infections remain a significant concern and there are currently no long-term strategies for their prevention. The Australasian Malignant PLeural Effusion (AMPLE)-4 trial is a multicentre randomised trial that evaluates the use of topical mupirocin prophylaxis (vs no mupirocin) to reduce catheter-related infections in patients with MPE treated with an IPC. Methods A pragmatic, multi-centre, open-labelled, randomised trial. Eligible patients with MPE and an IPC will be randomised 1:1 to either regular topical mupirocin prophylaxis or no mupirocin (standard care). For the interventional arm, topical mupirocin will be applied around the IPC exit-site after each drainage, at least twice weekly. Weekly follow-up via phone calls or in person will be conducted for up to 6 months. The primary outcome is the percentage of patients who develop an IPC-related (pleural, skin, or tract) infection between the time of catheter insertion and end of follow-up period. Secondary outcomes include analyses of infection (types and episodes), hospitalisation days, health economics, adverse events, and survival. Subject to interim analyses, the trial will recruit up to 418 participants. Discussion Results from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections. Ethics and dissemination Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences. Trial registration Australia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023.
