NCT03859362

Ertapenem in Patients With Urosepsis

Pharmacodynamics of Ertapenem in Patients With Urosepsis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Prince of Songkla University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ertapenem, a broad-spectrum carbapenem antibiotic, has shown promising in vitro activity agenst ESBL-producing Enterobacteriacae. This agent was licensed in United State of America and Europe for several clinical use in complicated intraabdominal infections, complicated skin and skin-structure infections, acute pelvic infections, complicated urinary tract infections and community-acquired pneumonia. In common with other beta-lactams, ertapenem exhibits primarily time-dependent activity, and the percentage of the exposure time during which the free drug concentration remain above the MIC (%T\>MIC) is the pharmacokinetic/pharmacodynamics (PK/PD) index that best correlates with efficacy. Pathophysiological changes in critically ill patients with severe infections resulting in altered PK patterns that may affect therapeutic plasma concentrations and achievement of PD have been found with several antimicrobial agents. The aim of the study was to determine the PK of ertapenem in patients with urosepsis.

Conditions

• Patients With Urosepis and Received Ertapenem for Treatment

Interventions

Type	Name	Description
DRUG	Ertapenem Injection	1 g of ertapenem q24h, 30 min infusion

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-30
• Completion: 2021-12-31
• First posted: 2019-03-01
• Last updated: 2019-03-01

Locations

1 site across 1 country: Thailand