E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 22, 2010
CompletedFirst Posted
Study publicly available on registry
December 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 10, 2015
June 1, 2015
3.2 years
December 22, 2010
June 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major error defined as the MIC(s) classified as R or I by E test method and S by referent method
2 days
Secondary Outcomes (1)
Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method
2 days
Study Arms (1)
E test method
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- all patients with suspected HAP undergoing BAL will be eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Bordeaux
Bordeaux, 33000, France
Related Publications (1)
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.
PMID: 30538161DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
December 22, 2010
First Posted
December 24, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
June 10, 2015
Record last verified: 2015-06