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Direct E-test on Bronchoalveolar Lavage From Patients With Ventilator-acquired Pneumonia

Primary Purpose

Ventilator Acquired Pneumonia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
E test
standard culture method
Sponsored by
Université Victor Segalen Bordeaux 2
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ventilator Acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all patients with suspected VAP (defined by a Clinical Pulmonary Infection Score ≥5) 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 2

Arm Type

Experimental

Active Comparator

Arm Label

E test

standard culture method

Arm Description

Outcomes

Primary Outcome Measures

The occurrence of major errors, defined as isolates determined to be susceptible by the E-test but resistant by standard culture methods.

Secondary Outcome Measures

The occurrence of minor errors (defined as isolates determined to be resistant by the E-test and susceptible by the standard method), and a comparison of two methods of seeding BAL samples on Mueller Hinton agar plates (swabbing method, flooding method).

Full Information

First Posted
January 4, 2010
Last Updated
January 4, 2010
Sponsor
Université Victor Segalen Bordeaux 2
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1. Study Identification

Unique Protocol Identification Number
NCT01042353
Brief Title
Direct E-test on Bronchoalveolar Lavage From Patients With Ventilator-acquired Pneumonia
Official Title
Rapid Bacterial Antibiograms Determined by Direct E-test on Bronchoalveolar Lavage From Patients With Ventilator-acquired Pneumonia: a Prospective Comparison With Standard Culture Methods
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Université Victor Segalen Bordeaux 2

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Ventilator-acquired pneumonia (VAP) is the most prevalent nosocomial infection in intensive care units (ICUs). Early microbiological diagnosis and initial administration of appropriate antimicrobial therapy are associated with a better outcome. Broad-spectrum antibiotics should therefore be administered initially. However, inconsiderate antibiotic use can increase the prevalence of multi-resistant bacteria. Purpose: A rapid antimicrobial susceptibility method is required to decrease the unnecessary use of empirical broad-spectrum antibiotics. The aim of this study is to compare the efficiency of a rapid antibiogram, provided by E-test strips directly applied to bronchoalveolar lavage (BAL) samples and analysed at 24 h, to that obtained with standard methods of culture which provide a later result. Study design: This will be an open-label, prospective cohort study of consecutive patients with VAP, conducted in a medical ICU. In addition to standard culture methods, an E-test will be performed directly on BAL samples and analysed at 24 h. Each standard BAL culture will be used as a control for the E-test method. Primary outcome: The occurrence of major errors, defined as isolates determined to be susceptible by the E-test but resistant by standard culture methods. Secondary outcomes: The occurrence of minor errors (defined as isolates determined to be resistant by the E-test and susceptible by the standard method), and a comparison of two methods of seeding BAL samples on Mueller Hinton agar plates (swabbing method, flooding method). Eligibility criteria: Inclusion criteria: all patients with suspected VAP (defined by a Clinical Pulmonary Infection Score ≥5) 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. Interventions: BAL samples will be cultured by standard methods and the minimal inhibitory concentration (MIC) of bacteria to the usual antibiotics will be determined using standard procedures. At the time of BAL collection, a rapid antibiogram will be performed by placing E-test antibiotic strips (AB Biodisk) directly onto Mueller-Hinton agar plates seeded with the BAL specimen (both by flooding and swabbing). E-test strips will be impregnated with cefoxitin, piperacillin-tazobactam, cefepime, imipenem, ciprofloxacin and amikacin. At 24 h, the E-test plates will be photographed and then examined separately by both a bacteriologist and a medical ICU physician following a consensus method. The final E-test results will be compared with the standard MIC cultures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Acquired Pneumonia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E test
Arm Type
Experimental
Arm Title
standard culture method
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
E test
Intervention Description
At the time of BAL collection, a rapid antibiogram will be performed by placing E-test antibiotic strips (AB Biodisk) directly onto Mueller-Hinton agar plates seeded with the BAL specimen (both by flooding and swabbing). E-test strips will be impregnated with cefoxitin, piperacillin-tazobactam, cefepime, imipenem, ciprofloxacin and amikacin. At 24 h, the E-test plates will be photographed and then examined separately by both a bacteriologist and a medical ICU physician following a consensus method. The final E-test results will be compared with the standard MIC cultures.
Intervention Type
Procedure
Intervention Name(s)
standard culture method
Intervention Description
BAL samples will be cultured by standard methods and the minimal inhibitory concentration (MIC) of bacteria to the usual antibiotics will be determined using standard procedures
Primary Outcome Measure Information:
Title
The occurrence of major errors, defined as isolates determined to be susceptible by the E-test but resistant by standard culture methods.
Secondary Outcome Measure Information:
Title
The occurrence of minor errors (defined as isolates determined to be resistant by the E-test and susceptible by the standard method), and a comparison of two methods of seeding BAL samples on Mueller Hinton agar plates (swabbing method, flooding method).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients with suspected VAP (defined by a Clinical Pulmonary Infection Score ≥5) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alexandre Boyer, MD
Organizational Affiliation
Université Bordeaux 2
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22483191
Citation
Boyer A, Medrano J, Mzali F, Balick-Weber CC, Bessede E, Picard W, Clouzeau B, Bebear CM, Vargas F, Hilbert G, Rogues AM, Gruson D. Direct testing of bronchoalveolar lavages from ventilator-associated pneumonia patients. Diagn Microbiol Infect Dis. 2012 Jun;73(2):107-10. doi: 10.1016/j.diagmicrobio.2012.02.017. Epub 2012 Apr 5.
Results Reference
derived

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Direct E-test on Bronchoalveolar Lavage From Patients With Ventilator-acquired Pneumonia

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