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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03346603
Enrollment
801
Registered
2017-11-17
Start date
2018-02-08
Completion date
2020-12-31
Last updated
2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections, Urosepsis

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.

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.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
IHMA laboratories
CollaboratorUNKNOWN
Olive View-UCLA Education & Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Prevalence of ESBL-producing Enterobacteriaceae2 years
Prevalence of carbapenem-resistant Enterobacteriaceae (CRE)2 years
Prevalence of carbapenem-resistant non fermenting gram negative bacteria2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026