drugset / Trial / NCT03859362

Ertapenem in Patients With Urosepsis

NCT03859362

Phase 4 Unknown 12 enrolled Prince of Songkla University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-01
Primary completion
2018-12-30
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ertapenem Small molecule 1 g

Indications

No indication recorded.