Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia
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|ClinicalTrials.gov Identifier: NCT01379157|
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : September 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Ventilator Associated Pneumonia||Drug: Imipenem||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion|
|Study Start Date :||November 2011|
|Primary Completion Date :||August 2013|
|Study Completion Date :||July 2014|
Active Comparator: Conventional arm
Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days
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
Other Name: Tienam
Experimental: Extended infusion arm
Infusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days
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
Other Name: Tienam
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379157
|Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University|
|Hat Yai, Songkla, Thailand, 90110|