Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia

Prince of Songkla University

Status and phase: Completed; Phase 4

Conditions: Ventilator Associated Pneumonia

Treatments: Drug: Imipenem

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01379157

MISP 39337

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Conventional arm

Active Comparator group

Description:

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

Treatment:

Drug: Imipenem

Drug: Imipenem

Extended infusion arm

Experimental group

Description:

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

Treatment:

Drug: Imipenem

Drug: Imipenem