Ventilator Associated Pneumonia Clinical Trial
Official title:
Impact of Imipenem With Amikacin Pharmacokinetic and Pharmacodynamic
The study is a prospective open trial conducted in 4 centers, and designed to determine if pharmacokinetic (PK) and pharmacodynamic (PD) parameters of imipenem, associated with amikacin as empirical therapy, impact microbiological and clinical outcome of patients with Gram negative bacilli (GNB) ventilator-associated pneumonia (VAP).
Inappropriate initial antibiotherapy increases mortality of many serious infections. This is
the case for ventilator-associated pneumonia, frequently occurring during intensive care
unit (ICU) hospitalization, and whose 48 first hours of treatment are decisive.
It is well established that pharmacokinetic and pharmacodynamic parameters of antibiotics
are correlated with their clinical and microbiological effectiveness. However in ICU
patients, pharmacokinetic parameters of antibiotics suffer great variations, and bacteria
responsible for these infections are usually less sensitive to antibiotics, especially Gram
negative bacilli (GNB). An important pharmacodynamic variability may occur at the initial
phase of the antibiotic treatment, decisive for the infection's outcome.
We propose to evaluate the correlation between pharmacokinetic and pharmacodynamic profile
of the empirical antibiotic therapy and the microbiological and clinical outcome of VAP.
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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