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Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia

Sponsor
Prince of Songkla University (Other)
Overall Status
Completed
CT.gov ID
NCT01379157
Collaborator
Merck Sharp & Dohme LLC (Industry)
8
Enrollment
1
Location
2
Arms
32
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Tienam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Accessed PK/PD parameters [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University Hat Yai Songkla Thailand 90110

    Sponsors and Collaborators

    • Prince of Songkla University
    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sutep Jaruratanasirikul, Prof.Dr.Sutep Jaruratanasirikul, Prince of Songkla University
    ClinicalTrials.gov Identifier:
    NCT01379157
    Other Study ID Numbers:
    • MISP 39337
    First Posted:
    Jun 23, 2011
    Last Update Posted:
    Sep 20, 2017
    Last Verified:
    Dec 1, 2011
    Keywords provided by Sutep Jaruratanasirikul, Prof.Dr.Sutep Jaruratanasirikul, Prince of Songkla University
    Patients with ventilator-associated pneumonia
    Additional relevant MeSH terms:
    Pneumonia
    Pneumonia, Ventilator-Associated
    Imipenem

    Study Results

    No Results Posted as of Sep 20, 2017