Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia
1 other identifier
observational
427
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2019
CompletedFirst Posted
Study publicly available on registry
April 24, 2019
CompletedStudy Start
First participant enrolled
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMarch 29, 2023
March 1, 2023
2.6 years
April 20, 2019
March 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
30-day mortality
death from any cause within 30 days after the blood culture with bacteraemia is drawn
30 days
Secondary Outcomes (4)
In-hospital mortality
90 days
14-day mortality
14 days
90-day mortality
90 days
• Length of stay
90 days
Study Arms (2)
Ertapenem
Patients who received ertapenem as an empirical antibiotic
Other carbapenems
Patients who received carbapenems other than ertapenem as an empirical antibiotic
Interventions
Eligibility Criteria
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.
You may qualify if:
- Adults, either sex, ages 18 years or above
- Patients with 3GCRE bacteremia
- Patients admitted to any of the study sites
You may not qualify if:
- Discontinuation of antibiotic due to transition to hospice care
- Polymicrobial bacteremia
- Empirical antibiotic after 24 hours of first evidence of bacteremia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Related Publications (1)
Vasikasin V, Panuvatvanich B, Rawson TM, Holmes AH, Nasomsong W. Towards optimizing carbapenem selection in stewardship strategies: a prospective propensity score-matched study of ertapenem versus class 2 carbapenems for empirical treatment of third-generation cephalosporin-resistant Enterobacterales bacteraemia. J Antimicrob Chemother. 2023 Jul 5;78(7):1748-1756. doi: 10.1093/jac/dkad165.
PMID: 37252945DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2019
First Posted
April 24, 2019
Study Start
May 15, 2019
Primary Completion
December 31, 2021
Study Completion
October 1, 2022
Last Updated
March 29, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share