HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array

Condition(s) studied

Investigational drug(s) / intervention(s)

Lower tract respiratory samples: Within 1 hour from HAP or VAP suspicion, quantitative tracheal aspirate or bronchoalveolar lavage will be performed to confirm the diagnosis. Clinicians will be encouraged to perform BAL whenever possible

Multiplex PCR assay (Film-array Pneumonia Panel Plus): The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).

Lower respiratory tract standard culture: The lower tract respiratory samples will be analyzed using convention microbiological methods (including conventional Gram stain and semiquantitative culture on both selective/differential and screening agar media)

Blood sample standard culture: When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods

Study summary

Multicenter, randomized, controlled, open-label trial to assess if semiquantitative multiplex PCR assay, as compared to conventional microbiology, can reduce the percentage of patients without microbiological diagnosis in the first 24 hours from HAP/VAP suspicion, thus allowing early de-escalation.

Eligibility

Primary outcome measure(s)

• Proportion of patients without microbiological diagnosis of HAP/VAP within the first 24 hours — 24 hours
  Proportion of patients where a microbiological diagnosis of HAP/VAP is not avaiable within the first 24 hours

Trial sites (4)

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