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

March 28, 2006 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75004
        • Recruiting
        • Hotel Dieu
        • Contact:
        • Principal Investigator:
          • Rabbat antoine, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: RABBAT Antoine, MD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Registration Dates

First Submitted

March 28, 2006

First Submitted That Met QC Criteria

March 28, 2006

First Posted (Estimate)

March 30, 2006

Study Record Updates

Last Update Posted (Estimate)

March 30, 2006

Last Update Submitted That Met QC Criteria

March 28, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAP FOB
  • CNMR grant, cardiff

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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