Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Prince of Songkla University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sutep Jaruratanasirikul, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01379157
First received: May 5, 2011
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Ventilator Associated Pneumonia
Drug: Imipenem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Accessed PK/PD parameters [ Time Frame: 24 hours profile after first dose of trail drug. ] [ Designated as safety issue: No ]

    - 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



Estimated Enrollment: 12
Study Start Date: November 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional arm
Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days
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
Other Name: Tienam
Experimental: Extended infusion arm
Infusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days
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
Other Name: Tienam

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379157

Contacts
Contact: Sutep Jaruratanasirikul, M.D. 6674281485 jasutep@medicine.psu.ac.th

Locations
Thailand
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University Recruiting
Hat Yai, Songkla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Sutep Jaruratanasirikul, Prof.Dr.Sutep Jaruratanasirikul, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01379157     History of Changes
Other Study ID Numbers: MISP 39337
Study First Received: May 5, 2011
Last Updated: December 27, 2011
Health Authority: Thailand: Ethics Committee Faculty of Medicine, Prince of Songkhla University

Keywords provided by Prince of Songkla University:
Patients with ventilator-associated pneumonia

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Imipenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014