Community-acquired pneumonia Respiratory Pneumonia, organism unspecified
Conditions
Interventions
This study is a pragmatic, multicentre, open randomised controlled trial. We will recruit from 5 UK hospitals. Participants will be identified by the clinical care team or research nurse by assessing
Sponsors
NHS Lothian
University of Edinburgh
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalised for CAP 2. Uncomplicated CAP confirmed by physician 3. CURB65 score two or more 4. Aged 16 and over
Exclusion criteria
Exclusion criteria: 1. Immunodeficiency - defined as being on long term (?28 days) oral prednisolone 10mg or more per day or other long-term disease-modifying drug 2. All forms of pulmonary fibrosis including usual interstitial pneumonia, asbestosis, non-specific interstitial pneumonia, hypersensitivity pneumonitis, active sarcoidosis 3. No capacity to consent 4. Active malignancy 5. Solid organ transplant 6. COPD on domiciliary oxygen therapy 7. Palliative treatment only 8. Mechanical ventilation 9. End of life care 10. Previously randomised into this trial 11. Participation in another CTIMP or CIMD interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical outcome measured with Desirability of Outcome Ranking (DOOR) and then further ranked using the Response Adjusted for Duration of Antibiotic Risk, assessed at day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CAP resolution (Y/N), measured by improvement of symptoms and clinical signs related to CAP, CRP level< 20 mg/L, and not on antibiotics related to CAP, assessed at day 7 and day 30 2. Major adverse events (Y/N) and number, measured by clinician reporting an event in medical records, assessed at day 7 and day 30 3. Readmissions to hospital within 30 days due to CAP, measured by admission recorded in patient records, assessed at day 30 4. Death (at 30 days and time to death), measured by death recorded in patient records, assessed at day 30 5. Narrowing spectrum of antibiotics, measured by clinician confirming that antibiotic prescriptions were altered according to PIBCAP results, assessed at day 7 and day 30 6. Macrolide DDD, measured by calculating the daily dose of macrolide antibiotics prescribed, assessed at day 30 7. Alteration or addition of antibiotic therapy, measured by antibiotic prescriptions in medical records, assessed at day 7 and day 30 8. Length of hospital stay, measured by admission and discharge dates recorded in patient records, assessed at day 7 and day 30 9. Antibiotic side effects, measured by clinician reporting an event in medical records, assessed at day 7 and day 30 10. Antibiotic costs measured within trial analysis and longer term economic modelling, assessed at day 30 11. Participant symptoms, measured by clinician reporting an event in medical records, assessed at day 7 and day 30 12. Antibiotic resistance in bacteria isolated, measured within trial analysis, assessed at day 30 13. The optimum specimen(s) for assessment of CAP for bacteria, atypical bacteria and viruses, measured within trial analysis, assessed at day 30 14. Cost per QALY at 30 days, measured within trial analysis and longer term economic modelling, assessed at d | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed