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

Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00308659
Enrollment
Unknown
Registered
2006-03-30
Start date
2006-03-31
Completion date
Unknown
Last updated
2006-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Aquired Pneumonia

Brief summary

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

Detailed 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

Interventions

PROCEDUREFOB protected distal microbiological samplings

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

France

Contacts

Primary ContactHERER BERTRAND, MD
formation-aducation@cardif.asso.fr+33141878801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026