Ertapenem in Patients With Urosepsis

Prince of Songkla University

Status and phase: Unknown; Phase 4

Conditions: Patients With Urosepis and Received Ertapenem for Treatment

Treatments: Drug: Ertapenem Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03859362

ERTAESBL58372141

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Ertapenem in urosepsis

Experimental group

Description:

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.

Treatment:

Drug: Ertapenem Injection