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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01266863
Other study ID # ABoyer3
Secondary ID
Status Completed
Phase N/A
First received December 22, 2010
Last updated June 9, 2015
Start date September 2010
Est. completion date December 2013

Study information

Verified date June 2015
Source Université Victor Segalen Bordeaux 2
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
E test method
E test strips directly applied to BAL

Locations

Country Name City State
France CHU Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
Université Victor Segalen Bordeaux 2

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major error defined as the MIC(s) classified as R or I by E test method and S by referent method 2 days Yes
Secondary Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method 2 days Yes
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