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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

427 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-15

Study Completion Date

2022-10-01

Brief Summary

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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.

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Detailed Description

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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

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Bacteremia Infection, Bacterial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ertapenem

Patients who received ertapenem as an empirical antibiotic

Ertapenem

Intervention Type DRUG

Ertapenem injection

Other carbapenems

Patients who received carbapenems other than ertapenem as an empirical antibiotic

Carbapenems

Intervention Type DRUG

Other carbapenems injection

Interventions

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Ertapenem

Ertapenem injection

Intervention Type DRUG

Carbapenems

Other carbapenems injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No