About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03925402

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted September 17, 2020

Study Description

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.

  • Condition or Disease:Bacteremia
    Infection, Bacterial
  • Intervention/Treatment: Drug: Ertapenem
    Drug: Carbapenems
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Estimated Enrollment: 406 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia: a Propensity Score Analysis
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: January 2023
  • Estimated Study Completion Date: March 2023
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Ertapenem
Patients who received ertapenem as an empirical antibiotic
Drug: Ertapenem
Ertapenem injection
: Other carbapenems
Patients who received carbapenems other than ertapenem as an empirical antibiotic
Drug: Carbapenems
Other carbapenems injection
Outcome Measures
  • Primary Outcome Measures: 1. 30-day mortality [ Time Frame: 30 days ]
    death from any cause within 30 days after the blood culture with bacteraemia is drawn
  • Secondary Outcome Measures: 1. In-hospital mortality [ Time Frame: 90 days ]
    death from any cause within the duration of admission with bacteraemia
  • 2. 14-day mortality [ Time Frame: 14 days ]
    death from any cause within 14 days after the blood culture with bacteraemia is drawn
  • 3. 90-day mortality [ Time Frame: 90 days ]
    death from any cause within 90 days after the blood culture with bacteraemia is drawn
  • 4. • Length of stay [ Time Frame: 90 days ]
    Duration of admission with bacteraemia
Eligibility Criteria
  • Ages Eligible for Study: 18 to 99 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: 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.
Criteria

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

Contacts and Locations
Contacts

Contact: Vasin Vasikasin, MD 027633338 vvasin@gmail.com

Locations

Thailand
Phramongkutklao Hospital
Bangkok

Sponsors and Collaborators

Phramongkutklao College of Medicine and Hospital

More Information
  • Responsible Party: Phramongkutklao College of Medicine and Hospital
  • ClinicalTrials.gov Identifier: NCT03925402 History of Changes
  • Other Study ID Numbers: AMED2019
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: September 17, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Bacterial Infections Bacteremia