Ventilator Acquired Pneumonia Clinical Trial
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
- 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.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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