E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
- 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 ]
- 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 ]
|Study Start Date:||September 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Experimental: E test method||
Other: E test method
E test strips directly applied to BAL
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266863
|Bordeaux, France, 33000|