Evidence map›Paper›PMID 27422026›Full record

Trial reportTrials2016

Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2): study protocol for a randomised controlled trial.

Thomas P Hellyer, Niall H Anderson, Jennie Parker, Paul Dark, Tina Van Den Broeck, Suveer Singh, Ronan McMullan, Ashley M Agus, Lydia M Emerson, Bronagh Blackwood and 6 more

Erratum issued Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01972425 (A Randomised Controlled Trial of Biomarker-based Exclusion of VAP to Improve Antibiotic Stewardship), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT01972425 nacompletednot on this map

A Randomised Controlled Trial of Biomarker-based Exclusion of VAP to Improve Antibiotic Stewardship

TypeinterventionalSponsorNewcastle-upon-Tyne Hospitals NHS TrustRan2013 to 2016Enrolled211ConditionsVentilator-associated PneumoniaArmsBiomarker-based diagnostic
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Biomarkers in lower respiratory tract samples in the diagnosis of ventilator-associated pneumonia: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2025
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Biomarkers in Pneumonia-Beyond Procalcitonin.International journal of molecular sciences · 2019
    Review
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Thomas P HellyerInstitute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK. t.p.hellyer@ncl.ac.uk.
Niall H AndersonCentre for Population Health Sciences, University of Edinburgh, Medical School, Edinburgh, UK.
Jennie ParkerNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.
Paul DarkInstitute of Inflammation and Repair, University of Manchester, Manchester Academic Health Sciences Centre & Intensive Care Unit, Salford Royal NHS Foundation Trust, Greater Manchester, UK.
Tina Van Den BroeckBecton Dickinson Biosciences, Erembodegem, Aalst, Belgium.
Suveer SinghIntensive Care Unit, Chelsea and Westminster Hospital, Imperial College London, London, UK.
Ronan McMullanDepartment of Medical Microbiology, Kelvin Building, The Royal Hospitals, Belfast, UK.
Ashley M AgusNorthern Ireland Clinical Trials Unit, Elliot Dynes Building, The Royal Hospitals, Belfast, UK.
Lydia M EmersonCentre for Experimental Medicine, Queen's University Belfast, Belfast, UK.
Bronagh BlackwoodCentre for Experimental Medicine, Queen's University Belfast, Belfast, UK.
Savita GossainPublic Health Laboratory, Heart of England NHS Foundation Trust, Birmingham, UK.
Tim S WalshMRC Centre for Inflammation Research, University of Edinburgh, Edinburgh, UK.
Gavin D PerkinsUniversity of Warwick and Heart of England NHS Foundation Trust, Coventry, UK.
Andrew Conway MorrisDivision of Anaesthesia, Department of Medicine, University of Cambridge, Addenbrooke's Hospital, Cambridge Biomedical Campus, Cambridge, UK.
Daniel F McAuleyNorthern Ireland Clinical Trials Unit, Elliot Dynes Building, The Royal Hospitals, Belfast, UK.
A John SimpsonInstitute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
Newcastle University · GBQueen's University Belfast · GBHeart of England NHS Foundation Trust · GBRoyal Victoria Hospital · GBCentre for Inflammation Research · GBImperial College London · GBUniversity of Cambridge · GBUniversity of Edinburgh · GBUniversity of Manchester · GB

Funding

Department of HealthMedical Research Council G0901697Medical Research Council MR/L004933/1Medical Research Council MR/L004933/2Wellcome Trust
6 · The paper itself

Abstract

backgroundVentilator-acquired pneumonia (VAP) is a common reason for antimicrobial therapy in the intensive care unit (ICU). Biomarker-based diagnostics could improve antimicrobial stewardship through rapid exclusion of VAP. Bronchoalveloar lavage (BAL) fluid biomarkers have previously been shown to allow the exclusion of VAP with high confidence. METHODS/

designThis is a prospective, multi-centre, randomised, controlled trial to determine whether a rapid biomarker-based exclusion of VAP results in fewer antibiotics and improved antimicrobial management. Patients with clinically suspected VAP undergo BAL, and VAP is confirmed by growth of a potential pathogen at [≥] 10(4) colony-forming units per millilitre (CFU/ml). Patients are randomised 1:1, to either a 'biomarker-guided recommendation on antibiotics' in which BAL fluid is tested for IL-1β and IL-8 in addition to routine microbiology testing, or to 'routine use of antibiotics' in which BAL undergoes routine microbiology testing only. Clinical teams are blinded to intervention until 6 hours after randomisation, when biomarker results are reported to the clinician. The primary outcome is a change in the frequency distribution of antibiotic-free days (AFD) in the 7 days following BAL. Secondary outcome measures include antibiotic use at 14 and 28 days; ventilator-free days; 28-day mortality and ICU mortality; sequential organ failure assessment (SOFA) at days 3, 7 and 14; duration of stay in critical care and the hospital; antibiotic-associated infections; and antibiotic-resistant pathogen cultures up to hospital discharge, death or 56 days. A healthcare-resource-utilisation analysis will be calculated from the duration of critical care and hospital stay. In addition, safety data will be collected with respect to performing BAL. A sample size of 210 will be required to detect a clinically significant shift in the distribution of AFD towards more patients having fewer antibiotics and therefore more AFD. DISCUSSION: This trial will test whether a rapid biomarker-based exclusion of VAP results in rapid discontinuation of antibiotics and therefore improves antibiotic management in patients with suspected VAP.

trial registrationISRCTN65937227 . Registered on 22 August 2013. ClinicalTrials.gov, NCT01972425 . Registered on 24 October 2013.

Indexed as

Antimicrobial StewardshipUnnecessary ProceduresAnti-Bacterial AgentsBacteriaBiomarkersBronchoalveolar Lavage FluidClinical ProtocolsColony Count, MicrobialHospital MortalityHumansInterleukin-1betaInterleukin-8Length of StayOrgan Dysfunction ScoresPatient SelectionPneumonia, BacterialAnti-Bacterial AgentsBiomarkersCXCL8 protein, humanIL1B protein, humanInterleukin-1betaInterleukin-8Antibiotic stewardshipBiomarkerRandomised controlled trialVentilator-acquired pneumonia

Identifiers

PMID27422026
PMCPMC4947254
OpenAlexW2473068687

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.