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Clinical Trials/NCT01379157
NCT01379157
Completed
Phase 4

The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion

Prince of Songkla University1 site in 1 country8 target enrollmentNovember 2011

Overview

Phase
Phase 4
Intervention
Imipenem
Conditions
Ventilator Associated Pneumonia
Sponsor
Prince of Songkla University
Enrollment
8
Locations
1
Primary Endpoint
Accessed PK/PD parameters
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
July 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sutep Jaruratanasirikul

Prof.Dr.Sutep Jaruratanasirikul

Prince of Songkla University

Eligibility Criteria

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

Arms & Interventions

Conventional arm

Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days

Intervention: Imipenem

Extended infusion arm

Infusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days

Intervention: Imipenem

Outcomes

Primary Outcomes

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

Study Sites (1)

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