NCT01379157

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

Completed Phase 4 Last updated 19 September 2017

What this trial tests

Phase 4 trial testing Imipenem in Ventilator Associated Pneumonia in 8 participants. Completed in 1 July 2014.

Timeline

1 November 2011

Primary endpoint
1 August 2013

1 July 2014

Quick facts

Lead sponsor	Prince of Songkla University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 November 2011
Primary completion	1 August 2013
Estimated completion	1 July 2014
Sites	1 location across Thailand

Drugs / interventions tested

• Imipenem (IMIPENEM) — full drug profile →
• Imipenem (IMIPENEM) — full drug profile →

Conditions studied

• Ventilator Associated Pneumonia — all drugs for Ventilator Associated Pneumonia →

Sponsor

Prince of Songkla University

Who can join

Adults 20 to 90, any sex, with Ventilator Associated Pneumonia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Continuous versus intermittent infusions of antibiotics for the treatment of severe acute infections.
   Shiu J, Wang E, Tejani AM, Wasdell M. · · 2013 · cited 40× · PMID 23543565 · DOI 10.1002/14651858.cd008481.pub2