Prevalence of Antimicrobial-resistant Pathogens in Patients Admitted for UTIs

NCT ID: NCT03346603

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

801 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-08

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Tract Infections Urosepsis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

IHMA laboratories

UNKNOWN

Sponsor Role collaborator

Olive View-UCLA Education & Research Institute

OTHER

Sponsor Role lead

Responsible Party

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David A. Talan

Professor of Medicine in Residence

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Olive View-UCLA Medical Center

Sylmar, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33131912 (View on PubMed)

Other Identifiers

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1057381

Identifier Type: -

Identifier Source: org_study_id

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