Back to resultsE Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.
Primary Purpose
Hospital-acquired Pneumonia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
E test method
Sponsored by
About this trial
This is an interventional diagnostic trial for Hospital-acquired Pneumonia focused on measuring Hospital-acquired pneumonia, E test, Antibiogram, Bronchoalveolar lavage
Eligibility 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.
Sites / Locations
- CHU Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E test method
Arm Description
Outcomes
Primary Outcome Measures
Major error defined as the MIC(s) classified as R or I by E test method and S by referent method
Secondary Outcome Measures
Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method
Full Information
NCT ID
NCT01266863
First Posted
December 22, 2010
Last Updated
June 9, 2015
Sponsor
Université Victor Segalen Bordeaux 2
1. Study Identification
Unique Protocol Identification Number
NCT01266863
Brief Title
E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Victor Segalen Bordeaux 2
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital-acquired Pneumonia
Keywords
Hospital-acquired pneumonia, E test, Antibiogram, Bronchoalveolar lavage
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E test method
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
E test method
Intervention Description
E test strips directly applied to BAL
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30538161
Citation
Boyer A, Goret J, Clouzeau B, Romen A, Prevel R, Lhomme E, Vargas F, Hilbert G, Bebear C, Gruson D, M'Zali F. Tailoring Empirical Antimicrobial Therapy in Subjects With Ventilator-Associated Pneumonia With a 10-Hour E-Test Approach. Respir Care. 2019 Mar;64(3):307-312. doi: 10.4187/respcare.06255. Epub 2018 Dec 11.
Results Reference
derived
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E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.
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