Prevalence of Antimicrobial-resistant Pathogens in Patients Admitted for UTIs

NCT03346603 | Completed

• 1 other identifier: 1057381
• Study Type: observational
• Target: 801
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Tract Infections; Urosepsis

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead
• Centers for Disease Control and Prevention: collaborator
• IHMA laboratories: collaborator

Study Sites (1)

Olive View-UCLA Medical Center

Sylmar, California, 93311, United States

Location

Related Publications (1)

• 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.

  PMID: 33131912 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine in Residence

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 17, 2017
• Study Start: February 8, 2018
• Primary Completion: February 28, 2019
• Study Completion: December 31, 2020
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Approximately one year after main manuscript publication. Data will be available for 15 years.
• Access Criteria: Data sharing agreement

Locations

US (1)