Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prince of Songkla University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Imipenem

Criteria

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