NCT03925402

Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia

Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia: a Propensity Score Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 427 (actual)
• Sponsor: Phramongkutklao College of Medicine and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is non-inferior to other carbapenems in term of 30-day mortality.

Detailed description

There are limited data of the efficacy of ertapenem as the empiric treatment of serious invasive infections, such as bloodstream infections (BSIs), that are due to ESBL-producing Enterobacteriaceae. Previous studies of ertapenem were done in small group of patients, in less invasive infection, as a definite 'step-down' therapy, or as compared to other non-carbapenem antibiotics.

Conditions

• Bacteremia
• Infection, Bacterial

Interventions

Type	Name	Description
DRUG	Ertapenem	Ertapenem injection
DRUG	Carbapenems	Other carbapenems injection

Timeline

• Start date: 2019-05-15
• Primary completion: 2021-12-31
• Completion: 2022-10-01
• First posted: 2019-04-24
• Last updated: 2023-03-29

Locations

1 site across 1 country: Thailand

Regulatory

• FDA-regulated drug study