NCT02213783

Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Prince of Songkla University · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients With Febrile Neutropenia

Interventions

Type	Name	Description
DRUG	Imipenem	Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature
DRUG	Imipenem	Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-07-01
• Completion: 2013-09-01
• First posted: 2014-08-11
• Last updated: 2014-08-11

Locations

1 site across 1 country: Thailand