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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00308659
First received: March 28, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted

March 28, 2006
March 28, 2006
March 2006
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No Changes Posted
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Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)
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

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Community Aquired Pneumonia
Procedure: FOB protected distal microbiological samplings
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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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
Both
18 Years and older
No
Contact: HERER BERTRAND, MD +33141878801 formation-aducation@cardif.asso.fr
France
 
NCT00308659
SCAP FOB, CNMR grant, cardiff
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Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: RABBAT Antoine, MD APHP
Assistance Publique - Hôpitaux de Paris
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP