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Completed

NCT Number: NCT03925402

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

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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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infection, Bacterial Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ertapenem

Drug

Ertapenem injection

Carbapenems

Drug

Other carbapenems injection

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days

    death from any cause within 30 days after the blood culture with bacteraemia is drawn

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Other

Registry information

Official study title

Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia: a Propensity Score Analysis

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 24, 2019
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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