Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Antibiotic | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2024

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
Fitzgerald DB, Koegelenberg CFN, Yasufuku K, et al. Surgical and non-surgical management of malignant pleural effusions. Expert Rev Respir Med. 2018;12(1):15–26.CrossRefPubMed
2.
Sears D, Hajdu SI. The cytologic diagnosis of malignant neoplasms in pleural and peritoneal effusions. Acta Cytol. 1987;31(2):85–97.PubMed
3.
DiBonito L, Falconieri G, Colautti I, et al. The positive pleural effusion. A retrospective study of cytopathologic diagnoses with autopsy confirmation. Acta Cytol. 1992;36(3):329–32.PubMed
4.
Clive AO, Kahan BC, Hooper CE, et al. Predicting survival in malignant pleural effusion: development and validation of the lent prognostic score. Thorax. 2014;69(12):1098–104.CrossRefPubMed
5.
Hunt BM, Farivar AS, Vallières E, et al. Thoracoscopic talc versus tunneled pleural catheters for palliation of malignant pleural effusions. Ann Thorac Surg. 2012;94(4):1053–7 discussion 1057-9.CrossRefPubMed
6.
Thomas R, Fysh ETH, Smith NA, et al. Effect of an indwelling pleural catheter vs talc pleurodesis on hospitalization days in patients with malignant pleural effusion: the AMPLE randomized clinical trial. JAMA. 2017;318(19):1903–12.CrossRefPubMedPubMedCentral
7.
Davies HE, Mishra EK, Kahan BC, et al. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012;307(22):2383–9.CrossRefPubMed
8.
Feller-Kopman DJ, Reddy CB, DeCamp MM, et al. Management of malignant pleural effusions. An official ATS/STS/STR clinical practice guideline. Am J Respir Crit Care Med. 2018;198(7):839–49.CrossRefPubMed
9.
Bibby AC, Dorn P, Psallidas I, et al. ERS/EACTS statement on the management of malignant pleural effusions. Eur Respir J. 2018;52(1)
10.
11.
Miller RJ, Chrissian AA, Lee YCG, et al. AABIP evidence-informed guidelines and expert panel report for the management of indwelling pleural catheters. J Bronchology Interv Pulmonol. 2020;27(4):229–45.CrossRefPubMed
12.
Fysh ETH, Tremblay A, Feller-Kopman D, et al. Clinical outcomes of indwelling pleural catheter-related pleural infections: an international multicenter study. Chest. 2013;144(5):1597–602.CrossRefPubMed
13.
Sethi DK, Rhodes J, Webber MA, et al. S5 bacterial isolates from infected and non-infected indwelling pleural catheters. Thorax. 2022;77(Suppl 1):A7–A7.
14.
15.
Uttley L, Vardhan A, Mahajan S, et al. Decrease in infections with the introduction of mupirocin cream at the peritoneal dialysis catheter exit site. J Nephrol. 2004;17(2):242–5.PubMed
16.
Wong SS, Chu KH, Cheuk A, et al. Prophylaxis against gram-positive organisms causing exit-site infection and peritonitis in continuous ambulatory peritoneal dialysis patients by applying mupirocin ointment at the catheter exit site. Perit Dial Int. 2003;23(Suppl 2):S153–8.CrossRefPubMed
17.
Thodis E, Passadakis P, Panagoutsos S, et al. The effectiveness of mupirocin preventing staphylococcus aureus in catheter-related infections in peritoneal dialysis. Adv Perit Dial. 2000;16:257–61.PubMed
18.
Xu G, Tu W, Xu C. Mupirocin for preventing exit-site infection and peritonitis in patients undergoing peritoneal dialysis. Nephrol Dial Transplant. 2010;25(2):587–92.CrossRefPubMed
19.
Lim CT, Wong KS, Foo MW. The impact of topical mupirocin on peritoneal dialysis infection in singapore general hospital. Nephrol Dial Transplant. 2005;20(10):2202–6.CrossRefPubMed
20.
Tacconelli E, Carmeli Y, Aizer A, et al. Mupirocin prophylaxis to prevent staphylococcus aureus infection in patients undergoing dialysis: A meta-analysis. Clin Infect Dis. 2003;37(12):1629–38.CrossRefPubMed
21.
Mahajan S, Tiwari SC, Kalra V, et al. Effect of local mupirocin application on exit-site infection and peritonitis in an indian peritoneal dialysis population. Perit Dial Int. 2005;25(5):473–7.CrossRefPubMed
22.
Ispd peritonitis recommendations. 2016 update on prevention and treatment. Perit Dial Int. 2018;38(4):313.CrossRef
23.
Szeto CC, Li PK, Johnson DW, et al. ISPD catheter-related infection recommendations: 2017 update. Perit Dial Int. 2017;37(2):141–54.CrossRefPubMed
24.
Lau EPM, Faber S, Charlesworth C, et al. Topical antibiotics prophylaxis for infections of indwelling pleural/peritoneal catheters (TAP-IPC): a pilot study. Respirology. 2023.
25.
Muruganandan S, Azzopardi M, Fitzgerald DB, et al. Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial. Lancet Respir Med. 2018;6(9):671–80.CrossRefPubMed
Metadata
Title
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
Authors
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
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08065-1

Other articles of this Issue 1/2024

Trials 1/2024 Go to the issue

Study protocol

Zero Self-Harm app: a mobile phone application to reduce non-suicidal self-injury—study protocol for a randomized controlled trial

Study protocol

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial

Study protocol

Optimization of cardiopulmonary bypass prime fluid to preserve microcirculatory perfusion during on-pump coronary artery bypass graft surgery: PRIME study protocol for a double-blind randomized trial

Study protocol

The effectiveness of therapeutic craft-making activities in treating lower-third forearm fracture: study protocol for a randomized controlled trial

Study protocol

Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study)

Study protocol

A physiotherapy group exercise and self-management approach to improve physical activity in people with mild-moderate Parkinson’s disease: a randomized controlled trial