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

Not Applicable

Completed

• Conditions: Hospital-acquired Pneumonia
• Interventions: Other: E test method

• Registration Number: NCT01266863
• Lead Sponsor: Université Victor Segalen Bordeaux 2

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-24
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-09
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E test method	E test method	-

Primary Outcome Measures

Name	Time	Method
Major error defined as the MIC(s) classified as R or I by E test method and S by referent method	2 days

Secondary Outcome Measures

Name	Time	Method
Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method	2 days

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Bordeaux, France