Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia

Overview

Imipenem is a carbapenem antibacterial agent with a broad spectrum of activity against Gram-negative and Gram-positive bacteria. This agent is often used as the last line of therapy for highly resistant Gram negative bacilli nosocomial infections. In common with other beta-lactamase inhibitor, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with the therapeutic efficacy is the time that concentrations in the tissue and serum are above the MIC and administration by continuous infusion is the preferred mode of administration to maximize this parameter. However, in tropical countries, the stability of carbapenem antibiotics is an important consideration when considering continuous infusion. Therefore, prolonged infusion may be a useful mode of administration to maximize bactericidal activity. This study will demonstrate the stability of imipenem in clinical use at room temperature in tropical countries.

Full Title of Study: “The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2013

Interventions

  • Drug: Imipenem
    • Each patient will receive a loading dose of 0.5 g 3 min infusion followed by 0.5 hr infusion of 0.5 g every 6 hr of imipenem at room temperature
  • Drug: Imipenem
    • Each patient will receive a loading dose of 0.5 g 3 min infusion followed by 4 hr infusion of 1 g every 8 hr of imipenem at room temperature

Arms, Groups and Cohorts

  • Active Comparator: Conventional arm
    • Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days
  • Experimental: Extended infusion arm
    • Infusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days

Clinical Trial Outcome Measures

Primary Measures

  • Accessed PK/PD parameters
    • Time Frame: 24 hours profile after first dose of trail drug.
    • – To determine plasma Imipenem PK/PD parameters (the PK/PD index (T>MIC), the probability of target attainment (PTA) at 40% (T>MIC), the cumulative fraction of response (CFR))after 4 hr infusion of 1 gm every 8 hr compared to 0.5 hr infusion of 0.5 gm every 6 hr. Conventional arm: after first dose, blood samples will be obtained by direct venepuncture at: time 0, 0.5, 6, 6.5, 12, 12.5, 18, 18.25, 18.5, 18.75, 20, 21, 22 and 24 hr Extended infusion arm: after first dose, blood samples will be obtained by direct venepuncture at: time 0, 4, 8, 12, 16, 16.5, 17, 18, 20, 20.5, 21, 22, and 24 hr

Participating in This Clinical Trial

Inclusion Criteria

  • Patients aged > or = 20 years – Patients who have VAP with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion Exclusion Criteria:

  • Patients who have documented hypersensitivity to imipenem or other carbapenems – Patients who have an estimated creatinine clearance of < or = 60 ml/min – Patients who are in circulatory shock – Patients who are pregnant

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Prince of Songkla University
  • Collaborator
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sutep Jaruratanasirikul, Prof.Dr.Sutep Jaruratanasirikul – Prince of Songkla University

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