Ertapenem in Patients With Urosepsis

Patients With Urosepis and Received Ertapenem for Treatment Clinical Trial

Official title:

Pharmacodynamics of Ertapenem in Patients With Urosepsis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03859362
• Other study ID #: ERTAESBL58372141
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2019
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients With Urosepis and Received Ertapenem for Treatment

Intervention

Drug:
• Ertapenem Injection
1 g of ertapenem q24h, 30 min infusion

Locations

Country	Name	City	State
Thailand	Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of ertapenem in plasma		48 hours after the ertapenem dose