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CompletedNCT03346603Updated Jul 8, 2021

Prevalence of Antimicrobial-resistant Pathogens in Patients Admitted for UTIs

An observational study in Urinary Tract Infections and Urosepsis, sponsored by Olive View-UCLA Education & Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-08.

Sponsored by Olive View-UCLA Education & Research Institute · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
801
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Urinary Tract Infections
  • Urosepsis
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In context

Urinary Tract Infections

803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.

This study's enrollment of 801 is above the median of 236 across 198 observational studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

Olive View-UCLA Education & Research Institute is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
801 participants (actual)
Patient registry
No

Interventions

  • Otherurine culture and susceptibility testing

    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.

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What researchers measure

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

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Study locations

1 site
  • Olive View-UCLA Medical Center
    Sylmar, California 93311, United States
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References and documents

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. PubMed 33131912 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Informed consent form

Time frame: Approximately one year after main manuscript publication. Data will be available for 15 years.

Access criteria: Data sharing agreement

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03346603
Lead sponsor
Olive View-UCLA Education & Research Institute
Collaborators
Centers for Disease Control and Prevention, IHMA laboratories
Responsible party
David A. Talan (Professor of Medicine in Residence, Olive View-UCLA Education & Research Institute) — Principal investigator
First posted
Nov 17, 2017
Start date
Feb 8, 2018
Primary completion
Feb 28, 2019
Completion
Dec 31, 2020
Last update
Jul 8, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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