Prevalence of Antimicrobial-resistant Pathogens in Patients Admitted for UTIs

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Urosepsis
• Intervention / Treatment: Other: urine culture and susceptibility testing

• Study Type: Observational
• Enrollment (Actual): 801

Contacts and Locations

Study Locations

• United States
  • California
    • Sylmar, California, United States, 93311
      • Olive View-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the 11 U.S. emergency departments involved in the EMERGEncy ID NET study with a urinary tract infection requiring hospital admission.

The sites are:

Bellevue Hospital Center, New York; Brigham and Women's Hospital, Boston, MA; Hennepin County Medical Center, Minneapolis; Johns Hopkins Medical Center, Baltimore; Lewis Katz School of Medicine at Temple University, Philadelphia; Maricopa Medical Center, Phoenix; Oregon Health Sciences University, Portland; Olive View-University of California at Los Angeles Medical Center, Los Angeles; University of New Mexico Health Sciences Center, Albuquerque; University of Mississippi Medical Center, Jackson; University of Missouri-Kansas City, Kansas City.

Description

Inclusion Criteria:

1. Age greater than or equal to 18 years;
2. Admitted to the hospital through the ED;
3. Primary reason for admission is treatment of UTI with or without sepsis (i.e., ED diagnosis of UTI and/or sepsis); and
4. 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 :

  1. they are unable to provide a urine specimen for culture; or
  2. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of ESBL-producing Enterobacteriaceae	2 years
Prevalence of carbapenem-resistant Enterobacteriaceae (CRE)	2 years
Prevalence of carbapenem-resistant non fermenting gram negative bacteria	2 years

Collaborators and Investigators

• Sponsor: Olive View-UCLA Education & Research Institute
• Collaborators: Centers for Disease Control and Prevention; IHMA laboratories

Publications and helpful links

General Publications

• Talan DA, Takhar SS, Krishnadasan A, Mower WR, Pallin DJ, Garg M, Femling J, Rothman RE, Moore JC, Jones AE, Lovecchio F, Jui J, Steele MT, Stubbs AM, Chiang WK, Moran GJ. Emergence of Extended-Spectrum beta-Lactamase Urinary Tract Infections Among Hospitalized Emergency Department Patients in the United States. Ann Emerg Med. 2021 Jan;77(1):32-43. doi: 10.1016/j.annemergmed.2020.08.022. Epub 2020 Oct 31.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections
• Other Study ID Numbers: 1057381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final research data will be shared with interested parties affiliated with research organizations, local and U.S. state health departments, and universities, who are interested in using the data for research purposes. Interested parties must submit a short description of how they plan to use the data to the Principal Investigator for approval. A data-sharing agreement will be required containing conditions for data use, including (1): a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroy or return the data after analyses are completed. Upon approval, the database will be shared with the requestor. All shared final research databases will not contain direct or indirect personal identifiers, and subjects will only be discernible by unique study identification numbers. A file containing a data dictionary with descriptions of all database fields will be included.
• IPD Sharing Time Frame: Approximately one year after main manuscript publication. Data will be available for 15 years.
• IPD Sharing Access Criteria: Data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No