Pneumonia, Lower respiratory tract infection Respiratory Pneumonia, Lower respiratory tract infection
Conditions
Interventions
Study arm (intervention arm) – patient sputum sample will be tested by rapid pneumonia assay (MICAP) and then have treatment guided in response to results. The treatment guidance is as per standard t
Sponsors
NHS Lothian
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 and over 2. Hospitalised 3. Lower respiratory tract specimen taken for routine microbiology within 48 hours of admission and - 3 or more of following signs or symptoms of respiratory tract infection: -new or worsening cough -new or worsening expectoration of sputum -haemoptysis -new or worsening dyspnea -pleuritic chest pain -fever -headache -abnormalities on chest auscultation or percussion
Exclusion criteria
Exclusion criteria: 1. Hospitalisation for more than 48 hours 2. No capacity to consent 3. Active malignancy 4. Immunodeficiency - defined as being on long term (?28 days) oral prednisolone 10mg or more per day or other long term disease modifying drug 5. Solid organ transplant 6. All forms of pulmonary fibrosis including usual interstitial pneumonia, asbestosis, non-specific interstitial pneumonia, hypersensitivity pneumonitis, active sarcoidosis 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 |
|---|---|
| To explore whether participants admitted with LRTI can safely receive personalised antibiotic therapy within 12 hours of consent for this test on existing sputum sample assessed by review of patient notes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CAP resolution at days 7 and 30 (Y/N) 2. Major adverse events (Y/N) and number. Major adverse events = complicated parapneumonic effusion, empyema, lung abscess, vascular event (acute coronary syndrome or cerebrovascular accident) or antibiotic-associated C. difficile, need for inotropic support, non-invasive or invasive ventilation or another major adverse event reported by the clinician and confirmed by the adjudication committee 3. Readmissions to hospital within 30 days due to LRTI 4. Death (at 30 days and time to death) 5. Narrowing spectrum of antibiotics assessed by drug chart for antibiotics given daily from date of consent 6. Macrolide DDD assessed by drug chart for antibiotics given daily from date of consent 7. Alteration or addition of antibiotic therapy assessed by drug chart for antibiotics given daily from date of consent 8. Length of hospital stay assessed by date of admission to date of discharge. Recovered for hospital records 9. Antibiotic side effects measured from date of consent assessed by notes of side effects attributed to antibiotics in clinical notes 10. Antibiotic costs assessed by costs from Pharmacy unit of current drug costs for the course given 11. Patient symptoms assessed using a pneumonia specific questionnaire 12. Antibiotic resistance in bacteria isolated assessed by MICs of bacteria isolated, resistance markers via molecular methods for bacteria detected by PCR 13. Assess the optimum specimen(s) for assessment of LRTI for bacteria, atypical bacteria and Viruses assessed by comparison of PCR results with sputum to throat swab where they exist 14. Cost per Quality-Adjusted Life Year at 30 days 15. Cost per DDD of antibiotics at 30 days | — |
Countries
United Kingdom
Contacts
Public ContactKate Templeton
Outcome results
None listed