Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379157
• Other study ID #: MISP 39337
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2011
• Last updated: September 19, 2017
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: December 2011
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

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
• 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

Locations

Country	Name	City	State
Thailand	Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkla

Sponsors (2)

Lead Sponsor	Collaborator
Prince of Songkla University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accessed PK/PD parameters	- 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	24 hours profile after first dose of trail drug.