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Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis

Surveillance and Risk Factor Analysis of Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis in the United States

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01641029
Enrollment
720
Registered
2012-07-16
Start date
2013-07-31
Completion date
2014-12-31
Last updated
2015-04-24

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

Conditions

Pyelonephritis

Brief summary

Pyelonephritis is a serious infection that manifests with fever, back pain, nausea, and vomiting. In the U.S., it is estimated that there are 20 cases of pyelonephritis per 10,000 annually, with the highest incidence in young women. Escherichia coli (E. coli) causes over 80% of these infections. Over the last two decades, E. coli resistance has emerged to commonly prescribed antimicrobials, such as ampicillin and trimethoprim-sulfamethoxazole (TMP/SMX). Most recently, resistance to fluoroquinolones and strains producing extended-spectrum beta-lactamases (ESBL) have been observed. In order to better understand the evolution and current state of antibiotic resistance among E. coli urinary tract isolates so as to better inform treatment decisions, the investigators propose to conduct an investigation to: a) determine the prevalence of antimicrobial resistance among E. coli causing acute pyelonephritis in various patient groups, and specifically healthy community-dwellers with uncomplicated infections, b) determine the specific prevalence of fluoroquinolone-resistance and ESBL-producing E. coli, and c) determine potential risk factors for fluoroquinolone and ESBL-producing E. coli infections.

Interventions

OTHERNo intervention

There is no intervention

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
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
Yes

Inclusion criteria

* patients \> 18 years of age with flank pain and/or costovertebral angle tenderness * documented temperature in the emergency department of ≥38°C/100.4°F by any method of measurement, * documented temperature in the emergency department of ≥38°C/100.4°F by any method of measurement,

Exclusion criteria

* complicated pyelonephritis

Design outcomes

Primary

MeasureTime frame
Prevalence of antimicrobial resistant E. coli in the U.S.July 2013-July 2014

Countries

United States

Outcome results

None listed

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