Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

Prince of Songkla University12 enrolled

Overview

This is prospective and randomized study to compare the pharmacodynamics (t\>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection. Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T\>MIC) and reported to %PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Patients With Febrile Neutropenia

Interventions

ImipenemDRUG

Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature

ImipenemDRUG

Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged \> or = 20 years * Patients who have febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion * Patients who are likely to survive 3 days Exclusion Criteria: * Patients who have documented hypersensitivity to imipenem or other carbapenems * Patients who have an estimated creatinine clearance of \< 50 ml/min * Patients who are in circulatory shock or hypotension (systolic \< 90 mmHg) * Patients who are pregnant

Locations (1)

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

Hat Yai, Changwat Songkhla, Thailand

Outcomes

Primary Outcomes

Concentration of imipenem in plasma

Concentration of imipenem in plasma will be determined by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T\>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).

Time frame: 6 hours profile after 8th dose of imipenem

Data from ClinicalTrials.gov

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