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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03925402
Enrollment
427
Registered
2019-04-24
Start date
2019-05-15
Completion date
2022-10-01
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Infection, Bacterial

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.

Interventions

DRUGErtapenem

Ertapenem injection

Other carbapenems injection

Sponsors

Phramongkutklao College of Medicine and Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
30-day mortality30 daysdeath from any cause within 30 days after the blood culture with bacteraemia is drawn

Secondary

MeasureTime frameDescription
In-hospital mortality90 daysdeath from any cause within the duration of admission with bacteraemia
14-day mortality14 daysdeath from any cause within 14 days after the blood culture with bacteraemia is drawn
90-day mortality90 daysdeath from any cause within 90 days after the blood culture with bacteraemia is drawn
• Length of stay90 daysDuration of admission with bacteraemia

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026