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
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||Phase|
|Ventilator-associated Pneumonia||Other: Biomarker-based diagnostic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomised Controlled Trial of Biomarker-based Exclusion of VAP to Improve Antibiotic Stewardship|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||November 2016|
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
- Antibiotic free days (AFD) [ Time Frame: 7 days ]The frequency distribution of antibiotic-free days (AFD) in the 7 days following BAL
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
|Principal Investigator:||John Simpson||Newcastle University|