Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia

NCT ID: NCT01379157

Last Updated: 2017-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional arm

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

Group Type: ACTIVE_COMPARATOR

Imipenem

Intervention Type: 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

Extended infusion arm

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

Group Type: EXPERIMENTAL

Imipenem

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Tienam; Tienam

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: lead

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Sutep Jaruratanasirikul

Prof.Dr.Sutep Jaruratanasirikul

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Hat Yai, Changwat Songkhla, Thailand

Countries

Thailand

Other Identifiers

MISP 39337

Identifier Type: -

Identifier Source: org_study_id