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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00308659
• Other study ID #: SCAP FOB
• Secondary ID: CNMR grant, card
• Status: Recruiting
• Phase: N/A
• First received: March 28, 2006
• Last updated: March 28, 2006
• Start date: March 2006

Study information

• Verified date: March 2006
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: HERER BERTRAND, MD
• Phone: +33141878801
• Email: formation-aducation[@]cardif.asso.fr
• Is FDA regulated: No
• Health authority: France: CPPRB
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Community Aquired Pneumonia
• Pneumonia

Intervention

Procedure:
• FOB protected distal microbiological samplings

Locations

Country	Name	City	State
France	Hotel dieu	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France,