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

Bacteremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925402
• Other study ID #: AMED2019
• Status: Completed
• Start date: May 15, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2023
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: October 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Bacterial Infections
• Infection, Bacterial

Intervention

Drug:
• Ertapenem
Ertapenem injection
• Carbapenems
Other carbapenems injection

Locations

Country	Name	City	State
Thailand	Phramongkutklao Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	death from any cause within 30 days after the blood culture with bacteraemia is drawn	30 days
Secondary	In-hospital mortality	death from any cause within the duration of admission with bacteraemia	90 days
Secondary	14-day mortality	death from any cause within 14 days after the blood culture with bacteraemia is drawn	14 days
Secondary	90-day mortality	death from any cause within 90 days after the blood culture with bacteraemia is drawn	90 days
Secondary	• Length of stay	Duration of admission with bacteraemia	90 days