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

Phramongkutklao College of Medicine and Hospital

Status: Completed

Conditions: Bacteremia; Infection, Bacterial

Treatments: Drug: Ertapenem; Drug: Carbapenems

Study type: Observational

Funder types: Other

Identifiers

NCT03925402

AMED2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 427 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults, either sex, ages 18 years or above
• Patients with 3GCRE bacteremia
• Patients admitted to any of the study sites

Exclusion criteria

• Discontinuation of antibiotic due to transition to hospice care
• Polymicrobial bacteremia
• Empirical antibiotic after 24 hours of first evidence of bacteremia

Trial design

427 participants in 2 patient groups

Ertapenem

Description:

Patients who received ertapenem as an empirical antibiotic

Treatment:

Drug: Ertapenem

Other carbapenems

Description:

Patients who received carbapenems other than ertapenem as an empirical antibiotic

Treatment:

Drug: Carbapenems