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

This study is currently recruiting participants.
Verified June 2012 by Université Victor Segalen Bordeaux 2
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

Resource links provided by NLM:


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
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 April 14, 2014