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

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00308659

Purpose

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

Condition	Intervention
Community Aquired Pneumonia	Procedure: FOB protected distal microbiological samplings

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Study Start Date:

March 2006

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308659

Contacts

Contact: HERER BERTRAND, MD

+33141878801

formation-aducation@cardif.asso.fr

Locations

France
Hotel dieu	Recruiting
Paris, France, 75004
Contact: Rabbat antoine, MD +33142348637 antoine.rabbat@htd.aphp.fr
Principal Investigator: Rabbat antoine, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

RABBAT Antoine, MD

APHP

More Information

Study ID Numbers:	SCAP FOB, CNMR grant, cardiff
Study First Received:	March 28, 2006
Last Updated:	March 28, 2006
ClinicalTrials.gov Identifier:	NCT00308659
Health Authority:	France: CPPRB

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on January 14, 2009