Ertapenem in Patients With Urosepsis

Phase 4

• Conditions: Patients With Urosepis and Received Ertapenem for Treatment
• Interventions: Drug: Ertapenem Injection

• Registration Number: NCT03859362
• Lead Sponsor: Prince of Songkla University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2018-12-30
• Status Verified: 2019-02
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-28
• Last Update Submitted: 2019-02-28
• Study First Posted: 2019-03-01
• Last Update Posted: 2019-03-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ertapenem in urosepsis	Ertapenem Injection	Ertapenem PK studies were carried out on the 3rd dose of ertapenem administration. Blood samples (3 mL) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 h after the start of ertapenem administration. All blood samples were added to a heparinized tube and centrifuged at 1,000 g for 10 min at 4°C within 5 min.

Primary Outcome Measures

Name	Time	Method
Concentration of ertapenem in plasma	48 hours after the ertapenem dose

Trial Locations

Locations (1)

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Songkla, Thailand