Pneumonia Respiratory Pneumonia
Conditions
Interventions
Patients in intensive care presenting with suspected Lower Respiratory Tract Infections (LRTIs) including Hospital Acquired Pneumonia (HAP) or Ventilator Acquired Pneumonia (VAP) will be potentially e
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ICU length of stay – time from randomisation to discharge from ICU 2. Number of ventilator-free days over 21 days post randomisation (VAP participants only surviving 21 days post randomisation) 3. Mortality - death from any cause within 28 days of randomisation 4. Incidence of septic shock – within 21 days of randomisation. 5. Change in SOFA (?SOFA) score from randomisation to 7 days post-randomisation (adults) 6. Change in PELOD-2 (?PELOD-2) score from randomisation to 7 days post-randomisation (children) 7. Change in pSOFA (?pSOFA) score from randomisation to 7 days post-randomisation (children) 8. % of participants on antibiotics active/inactive against the pathogen(s) found at 24 and 72h from randomisation 9. % of participants on proportionate/disproportionate antibiotics in relation to pathogen(s) found at 24 and 72h from randomisation 10. % of participants on narrow-spectrum antimicrobials at 24 and 72 h from randomisation 11. % of participants with specific adverse events associated with antibiotics within 21 day from randomisation 12. % of participants that contract a secondary pneumonia within 21 days from randomisation 13. Total antibiotic usage in Defined Daily Dose (DDDs) at 21 days post randomisation (all conditions) 14. In patient stay related costs Added 11/06/2020: COVID-19 observational sub-study: 1. Amongst those who received at least one prescription of antibiotics for a respiratory infection, the proportion of patients on narrow (vs broad) antibiotics at 24 h and 72 h from the start of respiratory antibiotics, comparing Biofire versus non Biofire groups 2. Amongst those who received at least one prescription for antibiotics for a respiratory infection, the proportion of patients on active and proportionate antibiotics at 24 h and 72 h from the start of respiratory antibiotics, comparing Biofire versus non Biofire groups 3. Amongst patients who had a Biofire test, length of stay in ICU, mortality and ventilator-free days within 28 days from I | — |
Countries
England, United Kingdom
Outcome results
None listed