The Population Pharmacokinetics of Imipenem in Patients With Ventilator-associated Pneumonia

This study has been completed.
Sponsor:
Collaborator:
Prince of Songkla University
Information provided by (Responsible Party):
Sutep Jaruratanasirikul, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01489124
First received: November 23, 2011
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

This is prospective, randomized and crossover design to assess the pharmacokinetic and pharmacodynamics of three regimen.

  • 0.5-hr infusion of imipenem 0.5 g every 6 hrs
  • 2-hr infusion of imipenem 0.5 g every 6 hrs
  • 2-hr infusion of imipenem 1 g every 6 hrs

Clinical and laboratory data such as Age,Sex, Body weight, CBC, Electrolyte, Vital signs, APACHE II score, BUN, Cr, Sample and Blood culture will be collected.

Nine patients will be enrolled in this study. After completion of the imipenem therapy for 3 days in this study, all patients will receive other sensitive antibiotics to eradicate their bacterial infections.

Blood samples (approximately 3 ml) will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4, 5 and 6 after 4th dose of imipenem.

Concentration of imipenem in plasma will be measured by HPLC method. Then, the data will be simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).


Condition Intervention Phase
Ventilator-Associated Pneumonia
Drug: Imipenem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Population Pharmacokinetics of Imipenem in Patients With Ventilator-associated Pneumonia

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Efficacy of imipenem administration by a 0.5 h and 2 h infusion [ Time Frame: At 0, 0.5, 1, 2, 3, 4, 5 and 6 hours after 4th dose of imipenem. ] [ Designated as safety issue: No ]
    Concentration of imipenem in plasma will be simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Fraction Response).


Enrollment: 9
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5 g of imipenem by 0.5-hr infusion
0.5 g of imipenem every 6 hrs administrated by 0.5-hr infusion for 3 days
Drug: Imipenem
0.5 g of imipenem every 6 hrs administrated by 0.5-hr infusion for 3 days
Other Name: Imipenem (Tienam)
Experimental: 0.5 g of imipenem by 2-hr infusion
0.5 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
Drug: Imipenem
0.5 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
Other Name: Imipenem (Tienam)
Experimental: 1 g of imipenem by 2-hr infusion
1 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
Drug: Imipenem
1 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
Other Name: Imipenem (Tienam)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years
  • Patients are intubated and receiving mechanical ventilation.
  • Patients have clinical suspicion of VAP with Gram negative bacilli infections, defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent tracheal secretions, temperature of 38.3°C or higher or a leucocyte count higher than 10000 cells/mm3.
  • Expected life expectancy ≥ 3 days

Exclusion Criteria:

  • Patients have documented hypersensitivity to imipenem or other carbapenems.
  • Patients have an estimated creatinine clearance < 60 ml/min
  • Patients are in circulatory shock (defined as a systolic blood pressure of < 90 mmHg).
  • Patients are pregnant.
  • Pretient receive imipenem for 2 weeks before randomization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489124

Locations
Thailand
Prince of Songkla University
Hat Yai, Songkla, Thailand, 90110
Sponsors and Collaborators
Sutep Jaruratanasirikul
Prince of Songkla University
Investigators
Principal Investigator: Sutep Jaruratanasirikul, MD Prince of Songkha
  More Information

No publications provided

Responsible Party: Sutep Jaruratanasirikul, Principal Investigator, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01489124     History of Changes
Other Study ID Numbers: IMI-50-372-028
Study First Received: November 23, 2011
Last Updated: December 8, 2011
Health Authority: Thailand: Ethics Committee, Faculty of Medicine, Prince of Songkhla University

Keywords provided by Prince of Songkla University:
Infection
Imipenem
Ventilator-Associated Pneumonia
pharmacokinetic
pharmacodynamic

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
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