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Biomarker-based Exclusion of VAP for Improved Antibiotic Stewardship (VAPRapid-2)

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ClinicalTrials.gov Identifier: NCT01972425
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Critically ill patients whose lungs are supported by breathing machines (ventilators) commonly develop a new lung infection, called ventilator-associated pneumonia (VAP). Because VAP is often fatal, antibiotics are administered whenever it is suspected. However VAP is hard to distinguish from several non-infective lung conditions and most patients with suspected VAP do not have pneumonia. Therefore many patients receive unnecessary antibiotics for several days, promoting emergence of 'superbugs'. Laboratory test results for diagnosing VAP typically only reach the doctors after 3 days.

A simple test rapidly and confidently excluding VAP should improve patient care, reduce unnecessary antibiotics and decrease costs. We recently showed that low levels of specific proteins in fluid from the lungs of patients with suspected VAP effectively excluded VAP, using a test that may yield results within 6 hours. The test used is an extension of existing technology produced by our commercial partner Becton Dickinson (BD) Biosciences.

Our previous findings were derived from a single hospital's intensive care unit. We have recently confirmed this finding across many intensive care units, which will help show that the test can be used in 'real life'. The aim of this study is to take the new test to the next step and determine whether it can improve the care of patients by reducing the amount of unnecessary antibiotics prescribed. This will be done using a 'randomised controlled trial', the best tool for scientifically testing a new diagnostic test. To do this we shall identify patients with suspected VAP, all of whom will have a lung sample - half of the patients will receive 'usual care' for suspected VAP, the other half will have the new test performed on their lung fluid. If the new test suggests no lung infection, the doctors will be asked to consider not giving antibiotics. We shall test how much antibiotic is given to each group.


Condition or disease Intervention/treatment
Ventilator-associated Pneumonia Other: Biomarker-based diagnostic

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Biomarker-based Exclusion of VAP to Improve Antibiotic Stewardship
Actual Study Start Date : October 2013
Primary Completion Date : September 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Biomarker-based diagnostic
Analyse sample on arrival
Other: Biomarker-based diagnostic
The intervention will be a biomarker-based diagnostic test for the exclusion of VAP
No Intervention: Routine use of antibiotics
Do not analyse the sample on arrival


Outcome Measures

Primary Outcome Measures :
  1. Antibiotic free days (AFD) [ Time Frame: 7 days ]
    The frequency distribution of antibiotic-free days (AFD) in the 7 days following BAL


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria are based on those for adults fulfilling criteria for suspected VAP:

  • Age ≥18 years
  • Mechanically ventilated for ≥ 48hrs
  • 2 or more of:
  • Temperature <35ºC or >38ºC
  • White cell count <4x109/L or >11x109/L
  • Purulent tracheal secretions
  • New or worsening CXR or CT scan changes
  • The patient is considered suitable for early discontinuation of antibiotics

Exclusion criteria are based on features considered to predict poor tolerance of BAL and adapted from our previous studies:

  • PaO2<8kPa on FiO2>0.7
  • Positive end-expiratory pressure >15cmH2O
  • Peak airway pressure >35 cmH2O
  • Heart rate >140 bpm
  • Mean arterial pressure <65mmHg
  • Bleeding diathesis (including platelet count <20x109 per litre of blood or international normalised ratio (INR) >3)
  • Poorly controlled intracranial pressure (>20mmHg)
  • ICU consultant deems procedure not to be safe
  • Previous BAL as part of this study
  • Consent declined

Patients who are enrolled in observational studies will be eligible for co-enrolment. Co-enrolment with interventional studies will be possible following consideration of any scientific or statistical interaction, in accordance with current UK critical care research forum (UKCCRF) recommendations (see appendix). Until co-enrolment is considered appropriate for a particular study, patients enrolled in an interventional trial will not be included.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972425


Locations
United Kingdom
Royal Victoria Hospital
Belfast, County Antrim, United Kingdom, BT12 6BA
Wansbeck General Hospital
Ashington, Tyne and Wear, United Kingdom
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Sunderland Royal Hospital
Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Sandwell and West Birmingham
Birmingham, United Kingdom
Countess of Chester Hospital
Chester, United Kingdom, CH2 1UL
University Hospital Coventry
Coventry, United Kingdom, CV4 7AL
Russells Hall Hospital
Dudley, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4TS
Western General Hospital
Edinburgh, United Kingdom
Queen Elizabeth Hospital
Gateshead, United Kingdom
Royal Liverpool Hospital
Liverpool, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Manchester Royal Infirmary
Manchester, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
North Tyneside General Hospital
North Shields, United Kingdom, NE29 8NH
Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Salford Royal Hospital
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Wellcome Trust
Investigators
Principal Investigator: John Simpson Newcastle University
More Information

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01972425     History of Changes
Other Study ID Numbers: NUTH6293
65937227 ( Registry Identifier: ISRCTN )
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents