Biomarker-based exclusion of ventilator-associated pneumonia for improved antibiotic stewardship

Not Applicable

Completed

• Conditions: Topic: Respiratory, Generic Health Relevance and Cross Cutting Themes; Subtopic: Respiratory (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Respiratory, Critical Care; Respiratory

• Registration Number: ISRCTN65937227
• Lead Sponsor: ewcastle Upon Tyne Hospitals NHS Trust and University of Newcastle Upon Tyne (UK)

Brief Summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27422026 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27974525 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31810865 (added 09/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-22
• Study Completion: 2016-11-25
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

Current inclusion criteria as of 27/11/2013:
1. Age 18 years or over
2. Mechanically ventilated for 48hrs
3. New or worsening changes on chest x-ray or CT scan of the lungs
4. Two or more from:
4.1. Temperature <35ºC or >38ºC
4.2. Blood white cell count <4x10*9/L or >11x10*9/L
4.3. Purulent tracheal secretions
5. The patient is considered suitable for early discontinuation of antibiotics
Target Gender: Male & Female ; Lower Age Limit 18 years

Previous inclusion criteria:
1. Age 18 years or over
2. Intubated and mechanically ventilated for 48 hrs
3. New or worsening changes on chest x-ray or CT scan of the lungs
4. Two or more from:
4.1. Temperature <35ºC or >38ºC
4.2. Blood white cell count <4x10*9/L or >11x10*9/L
4.3. Purulent tracheal secretions
Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. PaO2 <8kPa on FiO2 >0.7
2. Positive end-expiratory pressure >15 cmH2O
3. Peak airway pressure >35 cmH2O
4. Heart rate >140 bpm
5. Mean arterial pressure <65 mmHg
6. Bleeding diathesis (including platelet count <20x10*9 per litre of blood or international normalised ratio (INR) >3)
7. Poorly controlled intracranial pressure (>20 mmHg)
8. ICU consultant deems procedure not to be safe
9. Previous BAL as part of this study
10. 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 coenrolment
is considered appropriate for a particular study, patients enrolled in an interventional trial will not be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibiotic-free days (AFD); Timepoint(s): The frequency distribution of antibiotic-free days (AFD) in the 7 days following BA