Status:

COMPLETED

The Population Pharmacokinetics of Imipenem in Patients With Ventilator-associated Pneumonia

Lead Sponsor:

Sutep Jaruratanasirikul

Collaborating Sponsors:

Prince of Songkla University

Conditions:

Ventilator-Associated Pneumonia

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This is prospective, randomized and crossover design to assess the pharmacokinetic and pharmacodynamics of three regimen. * 0.5-hr infusion of imipenem 0.5 g every 6 hrs * 2-hr infusion of imipenem 0...

Detailed Description

Introduction: Ventilator-associated pneumonia (VAP) is a common cause of nosocomial infection with a high mortality rate. In the current era of increasing highly resistant pathogens in nosocomial infe...

Eligibility Criteria

Inclusion

  • Patients aged ≥ 18 years
  • Patients are intubated and receiving mechanical ventilation.
  • Patients have clinical suspicion of VAP with Gram negative bacilli infections, defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent tracheal secretions, temperature of 38.3°C or higher or a leucocyte count higher than 10000 cells/mm3.
  • Expected life expectancy ≥ 3 days

Exclusion

  • Patients have documented hypersensitivity to imipenem or other carbapenems.
  • Patients have an estimated creatinine clearance \< 60 ml/min
  • Patients are in circulatory shock (defined as a systolic blood pressure of \< 90 mmHg).
  • Patients are pregnant.
  • Pretient receive imipenem for 2 weeks before randomization.

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT01489124

Start Date

January 1 2008

End Date

January 1 2009

Last Update

December 9 2011

Active Locations (1)

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Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand, 90110