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

NCT01641029 | Completed

• 1 other identifier: 11H-770351
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Pyelonephritis

Outcome Measures

Primary Outcomes (1)

• Prevalence of antimicrobial resistant E. coli in the U.S.

  July 2013-July 2014

Study Arms (1)

pyelonephritis

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, and clinically suspected acute pyelonephritis. Patients will be identified by their emergency department treating physicians.

Other: No intervention

Interventions

No intervention OTHER

There is no intervention

pyelonephritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from ten U.S. university-affiliated medical center emergency departments participating in a CDC-collaborative emerging infections sentinel network, EMERGEncy ID NET. Patients presenting with symptoms of acute uncomplicated pyelonephritis will be enrolled by treating physicians or study coordinators.

You may qualify if:

• 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,

You may not qualify if:

• complicated pyelonephritis

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead
• Centers for Disease Control and Prevention: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

MeSH Terms

Conditions

Pyelonephritis

Condition Hierarchy (Ancestors)

Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 16, 2012
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

US (1)