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

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.

Study Overview

• Status: Completed
• Conditions: Bacteremia; Infection, Bacterial
• Intervention / Treatment: Drug: Ertapenem; Drug: Carbapenems

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.

• Study Type: Observational
• Enrollment (Actual): 427

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age and older admitted to Phramongkutklao Hospital, and Ananda Mahidol Hospital with 3GCRE monomicrobial bacteremia will be prospectively identified. In given a patient, only the initial episode of 3GCRE monomicrobial bacteremia during the study period will be included.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ertapenem; Patients who received ertapenem as an empirical antibiotic	Drug: Ertapenem; Ertapenem injection
Other carbapenems; Patients who received carbapenems other than ertapenem as an empirical antibiotic	Drug: Carbapenems; Other carbapenems injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	death from any cause within 30 days after the blood culture with bacteraemia is drawn	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	death from any cause within the duration of admission with bacteraemia	90 days
14-day mortality	death from any cause within 14 days after the blood culture with bacteraemia is drawn	14 days
90-day mortality	death from any cause within 90 days after the blood culture with bacteraemia is drawn	90 days
• Length of stay	Duration of admission with bacteraemia	90 days

Collaborators and Investigators

• Sponsor: Phramongkutklao College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: April 20, 2019
• First Submitted That Met QC Criteria: April 20, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Ertapenem
• Other Study ID Numbers: AMED2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No