E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
| 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 |
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| Contact: Alexandre Boyer, M.D. | alexandre.boyer@chu-bordeaux.fr |
| France | |
| CHU Bordeaux | Recruiting |
| Bordeaux, France, 33000 | |
| Contact: Alexandre , Boyer alexandre.boyer@chu-bordeaux.fr | |
| Principal Investigator: Alexandre Boyer, M.D. | |
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 June 18, 2013