E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Université Victor Segalen Bordeaux 2.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Alexandre Boyer, Université Victor Segalen Bordeaux 2
ClinicalTrials.gov Identifier:
NCT01266863
First received: December 22, 2010
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.


Condition Intervention
Hospital-acquired Pneumonia
Other: E test method

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

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Further study details as provided by Université Victor Segalen Bordeaux 2:

Primary Outcome Measures:
  • Major error defined as the MIC(s) classified as R or I by E test method and S by referent method [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E test method Other: E test method
E test strips directly applied to BAL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients with suspected HAP undergoing BAL will be eligible

Exclusion Criteria:

  • contraindications for BAL (PaO2/FIO2 <100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria <104 CFU/ml.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01266863

Contacts
Contact: Alexandre Boyer, M.D. alexandre.boyer@chu-bordeaux.fr

Locations
France
CHU Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Alexandre , Boyer       alexandre.boyer@chu-bordeaux.fr   
Principal Investigator: Alexandre Boyer, M.D.         
Sponsors and Collaborators
Université Victor Segalen Bordeaux 2
  More Information

No publications provided

Responsible Party: Alexandre Boyer, Medical doctor, Université Victor Segalen Bordeaux 2
ClinicalTrials.gov Identifier: NCT01266863     History of Changes
Other Study ID Numbers: ABoyer3
Study First Received: December 22, 2010
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Université Victor Segalen Bordeaux 2:
Hospital-acquired pneumonia
E test
Antibiogram
Bronchoalveolar lavage

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

ClinicalTrials.gov processed this record on July 24, 2014