Community Aquired Pneumonia Clinical Trial
Official title:
Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings
Main hypothesis: microbiological diagnossis off severe community acquired pneumonia can be
performed by non invasive or semi invasive microbiological tools, semi invasive tools
including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy
(FOB). A microbiological diagnosis could improve antibiotic therapy efficacy and improve
patient's outcome.
These Two strategies have never been prospectivally evauated.
- Aim of the study: To evaluate 2 diagnostic strategies: non invasive or semi invasive
including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy
(FOB)for the care of patients admitted in intensive care for severe community acquired
pneumonia and receiving an empirical antibiotic therapy as recommanded by 2001 American
thoracic guidelines
- Type of study randomized multicentric controlled open study
ď‚·Type of study randomized multicentric controlled open study
Number of patients: 200 patients (100 patients in each group)admitted in ICU for SCAP
- Number of center : 5
- Clinical strategies under evaluation :
- Group A: semi-invasive strategy: FOB within 24 hours after ICU admission
- Group B: non-invasive strategy: no FOB within 24 hours after ICU admission
- Evaluation criteria:
Main criteria: Changes in initial empirical antibiotic treatment according to
microbiological results obtained in each group.
others
- FOB related complications
- Microbiological results
- Type of antibiotic treatment modifications
- ICU outcome and outcome at day 28
- Duration of antibiotic therapy and nimber of days without antibiotics at day 28 after
inclusion
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic