Evidence map›Paper›PMID 38594766›Full record

ArticleTrials2024

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 and 14 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 4 citations in OpenAlex.

  1. An unusual case of chylothorax.Breathe (Sheffield, England) · 2026
    Article
  2. Article
  3. Review
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 18 institutions in 6 countries.

Estee P M LauPleural Medicine Unit, Institute for Respiratory Health, Perth, Australia.ORCID http://orcid.org/0000-0003-0972-1210
Matthew IngPleural Medicine Unit, Institute for Respiratory Health, Perth, Australia.
Sona VekariaDepartment of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Australia.
Ai Ling TanPleural Medicine Unit, Institute for Respiratory Health, Perth, Australia.
Chloe CharlesworthDepartment of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Australia.
Edward FyshMedical School, Faculty of Health & Medical Sciences, University of Western Australia, Perth, Australia.
Ranjan ShresthaDepartment of Respiratory Medicine, Fiona Stanley Hospital, Perth, Australia.
Elaine L C YapDepartment of Respiratory Medicine, Middlemore Hospital, Auckland, New Zealand.
Nicola A SmithDepartment of Respiratory Medicine, Wellington Regional Hospital, Wellington, New Zealand.
Benjamin C H KwanDepartment of Respiratory and Sleep Medicine, The Sutherland Hospital, Sydney, Australia.
Tajalli SaghaieDepartment of Respiratory Medicine, Concord Repatriation General Hospital, Concord, NSW, Australia.
Bapti RoyDepartment of Respiratory and Sleep Medicine, Westmead Hospital, Sydney, Australia.
John GoddardDepartment of Respiratory Medicine, Sunshine Coast University Hospital, Birtinya, QLD, Australia.
Sanjeevan MuruganandanDepartment of Respiratory Medicine, Northern Health, Epping, VIC, Australia.
Arash BadieiThoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia.
Phan NguyenThoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia.
Mohamed Faisal Abdul HamidRespiratory Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Vineeth GeorgeDepartment of Respiratory and Sleep Medicine, John Hunter Hospital, New Lambton Heights, NSW, Australia.
Deirdre FitzgeraldDepartment of Respiratory Medicine, Tallaght University Hospital, Dublin, Ireland.
Nick MaskellAcademic Respiratory Unit, Bristol Medical School, University of Bristol, Bristol, UK.
David Feller-KopmanDepartment of Medicine, Section of Pulmonary and Critical Care Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Kevin MurraySchool of Population and Global Health, University of Western Australia, Perth, Australia.
Aron ChakeraMedical School, Faculty of Health & Medical Sciences, University of Western Australia, Perth, Australia.
Y C Gary LeePleural Medicine Unit, Institute for Respiratory Health, Perth, Australia. gary.lee@uwa.edu.au.
The University of Western Australia · AURoyal Adelaide Hospital · AUSir Charles Gairdner Hospital · AUConcord Repatriation General Hospital · AUDartmouth–Hitchcock Medical Center · USEdith Cowan University · AUFiona Stanley Hospital · AUGriffith University · AUInstitute for Respiratory Health · AUJohn Hunter Hospital · AUMiddlemore Hospital · NZNational University of Malaysia · MYNorthern Health · AUSutherland Hospital · AUTallaght University Hospital · IEUniversity of Bristol · GBWellington Hospital · NZWestmead Hospital · AU

Funding

Cancer Council Western Australia RPG0068
6 · The paper itself

Abstract

backgroundMalignant 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.

methodsA 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 registrationAustralia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023.

Indexed as

Catheter-Related InfectionsPleural Effusion, MalignantAnti-Bacterial AgentsCatheters, IndwellingHumansMulticenter Studies as TopicMupirocinPleurodesisPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicTalcAnti-Bacterial AgentsMupirocinTalcIndwelling catheterInfectionMupirocin; ProphylaxisPleuralTopical antibiotic

Identifiers

PMID38594766
PMCPMC11005276
OpenAlexW4394678390

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.