Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia

NCT01379157 | Completed Phase 4

• 1 other identifier: MISP 39337
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Keywords

Patients with ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Conventional arm

ACTIVE COMPARATOR

Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days

Drug: Imipenem

Extended infusion arm

EXPERIMENTAL

Infusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days

Drug: Imipenem

Interventions

Imipenem DRUG

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

Also known as: Tienam

Conventional arm

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \> or = 20 years
• Patients who have VAP with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Imipenem; Cilastatin, Imipenem Drug Combination

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.Sutep Jaruratanasirikul

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: June 23, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: July 1, 2014
• Last Updated: September 20, 2017

Record last verified: 2011-12

Locations

TH (1)