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

Pyelonephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641029
• Other study ID #: 11H-770351
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: April 23, 2015
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Olive View-UCLA Education & Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pyelonephritis

Intervention

Other:
• No intervention
There is no intervention

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, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of antimicrobial resistant E. coli in the U.S.		July 2013-July 2014	No