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

Completed

• Conditions: Bacteremia; Infection, Bacterial
• Interventions: Drug: Carbapenems; Drug: Ertapenem

• Registration Number: NCT03925402
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-20
• Study First Submitted QC: 2019-04-20
• Study First Posted: 2019-04-24
• Study Start: 2019-05-15
• Primary Completion: 2021-12-31
• Study Completion: 2022-10-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Other carbapenems	Carbapenems	Patients who received carbapenems other than ertapenem as an empirical antibiotic
Ertapenem	Ertapenem	Patients who received ertapenem as an empirical antibiotic

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 days	death from any cause within 30 days after the blood culture with bacteraemia is drawn

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand