Back to results

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

About this trial

This is an interventional diagnostic trial for Community Aquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

HERER BERTRAND, MD

Phone

+33141878801

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

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