Prevalence of Antimicrobial-resistant Pathogens in Patients Admitted for UTIs

Urinary Tract Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346603
• Other study ID #: 1057381
• Status: Completed
• Start date: February 8, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: Olive View-UCLA Education & Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: December 31, 2020
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infections
• Urosepsis

Intervention

Other:
• urine 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.

Locations

Country	Name	City	State
United States	Olive View-UCLA Medical Center	Sylmar	California

Sponsors (3)

Lead Sponsor	Collaborator
Olive View-UCLA Education & Research Institute	Centers for Disease Control and Prevention, IHMA laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of ESBL-producing Enterobacteriaceae		2 years
Primary	Prevalence of carbapenem-resistant Enterobacteriaceae (CRE)		2 years
Primary	Prevalence of carbapenem-resistant non fermenting gram negative bacteria		2 years