Skip to content

Ertapenem in Patients With Urosepsis

Pharmacodynamics of Ertapenem in Patients With Urosepsis

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03859362
Enrollment
12
Registered
2019-03-01
Start date
2017-01-31
Completion date
2021-12-31
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Urosepis and Received Ertapenem for Treatment

Keywords

pharmacokinetic, pharmacodynamic, ertapenem, urosepsis

Brief 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.

Interventions

DRUGErtapenem Injection

1 g of ertapenem q24h, 30 min infusion

Sponsors

Prince of Songkla University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \>18 years of age * Diagnosis of urosepsis

Exclusion criteria

* They were pregnant * Circulatory shock (defined as a systolic blood pressure of \< 90 mmHg and pour tissue perfusion) * Documented hypersensitivity to carbapenems * Estimated creatinine clearance (CLcr) (determined by the Crockcroft-Goult method) of \< 30 mL/min

Design outcomes

Primary

MeasureTime frame
Concentration of ertapenem in plasma48 hours after the ertapenem dose

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026