Clinical Trial: Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion
Brief Summary:
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.
Detailed Summary:
Sponsor: Prince of Songkla University
Current Primary Outcome: 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
Original Primary Outcome: Pharmacokinetics and pharmacodynamics of Imipenem [ Time Frame: 24 hours profile after first dose of trail drug. ]
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 after the start treatment with 0.5 hr infusion of 0.5 gm every 6 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 after the start treatment with 4 hr infusion of 1 g every 8 hr regimen.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Prince of Songkla University
Dates:
Date Received: May 5, 2011
Date Started: November 2011
Date Completion: May 2013
Last Updated: December 27, 2011
Last Verified: December 2011
