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

Lau EPM 1 , Ing M 1 , Vekaria S 2 , Tan AL 1 , Charlesworth C 2 , Fysh E 3 Show all authors , Shrestha R 4 , Yap ELC 5 , Smith NA 6 , Kwan BCH 7 , Saghaie T 8 , Roy B 9 , Goddard J 10 , Muruganandan S 11 , Badiei A 12 , Nguyen P 12 , Hamid MFA 13 , George V 14 , Fitzgerald D 15 , Maskell N 16 , Feller-Kopman D 17 , Murray K 18 , Chakera A 3 , Lee YCG 19

Affiliations 

  • 1 Pleural Medicine Unit, Institute for Respiratory Health, Perth, Australia
  • 2 Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Australia
  • 3 Medical School, Faculty of Health & Medical Sciences, University of Western Australia, Perth, Australia
  • 4 Department of Respiratory Medicine, Fiona Stanley Hospital, Perth, Australia
  • 5 Department of Respiratory Medicine, Middlemore Hospital, Auckland, New Zealand
  • 6 Department of Respiratory Medicine, Wellington Regional Hospital, Wellington, New Zealand
  • 7 Department of Respiratory and Sleep Medicine, The Sutherland Hospital, Sydney, Australia
  • 8 Department of Respiratory Medicine, Concord Repatriation General Hospital, Concord, NSW, Australia
  • 9 Department of Respiratory and Sleep Medicine, Westmead Hospital, Sydney, Australia
  • 10 Department of Respiratory Medicine, Sunshine Coast University Hospital, Birtinya, QLD, Australia
  • 11 Department of Respiratory Medicine, Northern Health, Epping, VIC, Australia
  • 12 Thoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia
  • 13 Respiratory Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
  • 14 Department of Respiratory and Sleep Medicine, John Hunter Hospital, New Lambton Heights, NSW, Australia
  • 15 Department of Respiratory Medicine, Tallaght University Hospital, Dublin, Ireland
  • 16 Academic Respiratory Unit, Bristol Medical School, University of Bristol, Bristol, UK
  • 17 Department of Medicine, Section of Pulmonary and Critical Care Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA
  • 18 School of Population and Global Health, University of Western Australia, Perth, Australia
  • 19 Pleural Medicine Unit, Institute for Respiratory Health, Perth, Australia. gary.lee@uwa.edu.au
Trials, 2024 Apr 10;25(1):249.
PMID: 38594766 DOI: 10.1186/s13063-024-08065-1

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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