Pneumonia and infection with Gram-negative bacteria Infections and Infestations
Conditions
Interventions
Patients hospitalized with suspicion of pneumonia and clinical indication for bronchoscopy will be screened for inclusion into the study. Patients with risk factors for infection with Gram-negative ba
Sponsors
University Hospital Basel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent as documented by signature 2. Clinical indication for diagnostic bronchoscopy with bronchoalveolar lavage 3. Suspicion of pneumonia (e.g. community-acquired pneumonia (CAP); aspiration pneumonia (AP); hospital acquired pneumonia (HAP); or acute pneumonic exacerbation of COPD based on: 3.1. New pulmonary infiltrate seen on chest radiograph or CT scan plus at least one of the following: 3.2. New or increased cough with/without sputum production 3.3. Fever (documented temperature –rectal or oral- = 38.3 Grad Celsius or hypothermia (documented temperature – rectal or oral - 10.0x109/l) or leukopenia (7.5 mg/d or equivalent for more than 4 weeks) or other immunosuppressive therapy (such as in connective tissue disease, rheumatic disease or solid organ transplantation) 5.3. Suspicion of or diagnosis of underlying chronic bronchopulmonary disease such as COPD, bronchiectasis, interstitial lung disease 5.4. Suspicion of aspiration 5.5. Recent or frequent antibiotic therapy within the last 3 months 5.6. Chemotherapy within the last 3 months 5.7. Immunocompromised status due to any condition such as haematological disease, haemodialysis, HIV, solid organ or stem cell transplantation 6. Adults (age 18 – 99)
Exclusion criteria
Exclusion criteria: Failure to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time (in hours) on inappropriate antibiotic therapy based on multiplex bacterial PCR, recorded daily until discharge or 30 days follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to clinical stability; vital signs recorded at inclusion and daily up to discharge or up to 30 days, whichever happens first 2. Length of hospital stay in days, measured until discharge up to 30 days 3. Mortality, measured at 30 days follow-up 4. Adverse events and their relation to antibiotic therapy, assessed daily by history taking and any examination as clinically indicated up to discharge or up to 30-day observational period 5. Diagnostic performance of the multiplex bacterial PCR (HPN Pneumonia panel) as compared to conventional microbiologic testing and to a second confirmatory multiplex PCR, measured at the BAL day for the intervention group and after completion of the study (last visit, last patient out) for the control group 6. Diagnostic performance of multiplex PCR from BAL compared to multiplex PCR from sputa, measured after completion of the study (last visit, last patient out) for both randomized groups | — |
Countries
Switzerland
Contacts
Public ContactDaiana Stolz
Outcome results
None listed