Inhale work package 3 – rapid versus standard testing to diagnose lung infections in intensive care, including COVID-19 observational sub-study

Not Applicable

Completed

• Conditions: Pneumonia; Respiratory

• Registration Number: ISRCTN16483855
• Lead Sponsor: niversity College London

Brief Summary

2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34099497/ (added 06/09/2023) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34620213/ (added 06/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-05
• Study Completion: 2022-04-30
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 558

Inclusion Criteria

1. About to receive an antimicrobial to treat a suspected lower respiratory infection (LRTI – including suspected HAP/VAP) for the first time, or a change in existing antimicrobial for LRTI because of deteriorating clinical condition. This relates both to spontaneously breathing patients and those who are intubated for any reason
2. In-patients in a participating ICU/CCU
3. Hospitalised for > 48 hours
4. Sufficient volume of airway specimen obtained for routine testing at site plus 200 microlitres for the FilmArray test

Exclusion Criteria

1. Previous inclusion in work programme 3
2. Concurrent participation in the active phase (defined as within 30 days of primary end point) of an interventional trial not agreed as acceptable for co-enrolment by the local PIs of both trials. Participants will be permitted to co-enrol in studies that do not involve an intervention (e.g. observational studies).
3. Moribund and/or not expected to live more than 48 h
4. Presence of an existing directive to withhold life-sustaining treatment
5. Prisoners or young offenders currently in custody of HM Prison Service or supervised by the probation service

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Non-inferiority in clinical cure of pneumonia at 14 days post randomisation. Cure of pneumonia defined as: absence of (i) death where the pneumonia was considered causative or at least contributory, (ii) septic shock (except when associated with a documented non-respiratory infection), or (iii) relapse of pneumonia. Relapse is defined as an infectious pulmonary event, associated with clinical and radiological signs of HAP or VAP, or a worsening of 2 points of the baseline multiple organ dysfunction score (SOFA or PELOD-2).2. Improvement in antimicrobial stewardship at 24 h post-randomisation. Defined as: Participants on active and proportionate antimicrobial therapy within 24 h of clinical diagnosis, where active therapy is defined as receiving an antimicrobial active against the organism(s) in vitro and proportionate as defined in the prescribing algorithm specific to that site.