Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Community Aquired Pneumonia

Treatments

Procedure: FOB protected distal microbiological samplings

Study type

Interventional

Funder types

Other

Identifiers

NCT00308659

CNMR grant, cardiff

SCAP FOB

Details and patient eligibility

About

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

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

New radiological infiltrate SCAP clinical diagnosis admitted in ICU Admitted in hospital for less than 24 hours Aged 18 or older Signed informed consent

Exclusion criteria

Pregnancy Muribond patients Previuos hospitalisation within One month Neutropenia None HIV status