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

• ClinicalTrials.gov Identifier: NCT01042353
• Recruitment Status: Completed
• First Posted: January 5, 2010
• Last Update Posted: January 5, 2010
• Sponsor: Université Victor Segalen Bordeaux 2
• Information provided by: Université Victor Segalen Bordeaux 2

Tracking Information

• First Submitted Date: January 4, 2010
• First Posted Date: January 5, 2010
• Last Update Posted Date: January 5, 2010
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: January 4, 2010): The occurrence of major errors, defined as isolates determined to be susceptible by the E-test but resistant by standard culture methods.
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: January 4, 2010): 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).
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Ventilator Acquired Pneumonia

Intervention

• Procedure: E test
  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.
• Procedure: standard culture method
  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

Study Arms

• Experimental: E test
  Intervention: Procedure: E test
• Active Comparator: standard culture method
  Intervention: Procedure: standard culture method

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: January 4, 2010): 20
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01042353
• Other Study ID Numbers: CHU BDX réa med
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Boyer, Service Réanimation Médicale CHU Bordeaux
• Original Responsible Party: Same as current
• Current Study Sponsor: Université Victor Segalen Bordeaux 2
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: alexandre Boyer, MD; Université Bordeaux 2

• PRS Account: Université Victor Segalen Bordeaux 2
• Verification Date: January 2010