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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03925402
Other study ID # AMED2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2019
Est. completion date October 1, 2022

Study information

Verified date March 2023
Source Phramongkutklao College of Medicine and Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 427
Est. completion date October 1, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Ertapenem
Ertapenem injection
Carbapenems
Other carbapenems injection

Locations

Country Name City State
Thailand Phramongkutklao Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-day mortality death from any cause within 30 days after the blood culture with bacteraemia is drawn 30 days
Secondary In-hospital mortality death from any cause within the duration of admission with bacteraemia 90 days
Secondary 14-day mortality death from any cause within 14 days after the blood culture with bacteraemia is drawn 14 days
Secondary 90-day mortality death from any cause within 90 days after the blood culture with bacteraemia is drawn 90 days
Secondary • Length of stay Duration of admission with bacteraemia 90 days
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