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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 20, 2014