Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)
Primary Purpose
Community Aquired Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FOB protected distal microbiological samplings
Sponsored by
About this trial
This is an interventional diagnostic trial for Community Aquired Pneumonia
Eligibility 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
Sites / Locations
- Hotel dieuRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00308659
First Posted
March 28, 2006
Last Updated
March 28, 2006
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00308659
Brief Title
Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)
Official Title
Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Aquired Pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
FOB protected distal microbiological samplings
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HERER BERTRAND, MD
Phone
+33141878801
Email
formation-aducation@cardif.asso.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RABBAT Antoine, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabbat antoine, MD
Phone
+33142348637
Email
antoine.rabbat@htd.aphp.fr
First Name & Middle Initial & Last Name & Degree
Rabbat antoine, MD
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)
We'll reach out to this number within 24 hrs