Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia

Phase 4

Completed

• Conditions: Ventilator Associated Pneumonia
• Interventions: Drug: Imipenem

• Registration Number: NCT01379157
• Lead Sponsor: Prince of Songkla University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-23
• Study Start: 2011-11
• Status Verified: 2011-12
• Primary Completion: 2013-08
• Study Completion: 2014-07
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended infusion arm	Imipenem	Infusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days
Conventional arm	Imipenem	Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Songkla, Thailand