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OpenTrials
Completed

NCT Number: NCT03346603

Prevalence of Antimicrobial-resistant Pathogens in Patients Admitted for UTIs

Between 2013-2014, our study network of U.S. emergency departments, EMERGEncy ID NET, found that the rate of fluoroquinolone-resistant E. coli was 11.7% among all patients, 6.3% in uncomplicated and 19.9% in complicated. ESBL-producing Enterobacteriaceae were found in 7.7% of all cases, 2.6% in uncomplicated and 12.2% in complicated. More recently, Enterobactericeae and gram-negative non fermenting bacteria have started to show resistance to carbapenems (CREs and CR-NF). Patients hospitalized with UTI and urosepsis represent a higher risk population for infections due to multi-drug resistant bacteria and experience serious adverse outcomes, including death. EMERGEncy ID NET will conduct a study to determine the prevalence of ESBL-producing, CREs and CR-NFs among this high risk population of patients admitted for UTI from U.S. emergency departments.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases Urosepsis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Olive View-UCLA Medical Center

Sylmar, California, 93311, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age greater than or equal to 18 years;
  • Admitted to the hospital through the ED;
  • Primary reason for admission is treatment of UTI with or without sepsis (i.e., ED diagnosis of UTI and/or sepsis); and
  • Provide verbal or written consent to participate in the study or if patient is unable to provide consent (e.g., altered mental status), consent obtained from a legal authorized representative.

Exclusion criteria

  • patients will be later excluded if :
  • they are unable to provide a urine specimen for culture; or
  • their urine culture yields no growth or is contaminated (see definition of positive urine culture below). Note: If participant's urine culture is contaminated but their blood culture is positive for a uropathogen, they will not be excluded.

Treatment and study plan

urine culture and susceptibility testing

Other

All patients will have a urine culture and susceptibility test ordered per standard care. Results of tests will identify which patients have antimicrobial-resistant organisms.

Primary outcomes

  1. Prevalence of ESBL-producing Enterobacteriaceae

    Time frame: 2 years

  2. Prevalence of carbapenem-resistant Enterobacteriaceae (CRE)

    Time frame: 2 years

  3. Prevalence of carbapenem-resistant non fermenting gram negative bacteria

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Olive View-UCLA Education & Research Institute

Other

Collaborators

  • Centers for Disease Control and Prevention
  • IHMA laboratories

Registry information

Official study title

Prevalence of Extended Spectrum β-lactamase and Carbapenem-Resistant Gram-Negative Bacteria in Patients With Urinary Tract Infection and Urosepsis Admitted Through Emergency Departments in the United States

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Jul 8, 2021

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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