Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

Phase 4

Completed

• Conditions: Patients With Febrile Neutropenia
• Interventions: Drug: Imipenem

• Registration Number: NCT02213783
• Lead Sponsor: Prince of Songkla University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2014-08
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-08
• Last Update Submitted: 2014-08-08
• Study First Posted: 2014-08-11
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional arm	Imipenem	Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 2-5 days
Extended infusion arm	Imipenem	Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days

Primary Outcome Measures

Name	Time	Method
Concentration of imipenem in plasma	6 hours profile after 8th dose of imipenem	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).

Trial Locations

Locations (1)

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