Trial record 5 of 18 for:    Open Studies | "Pyelonephritis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Olive View-UCLA Education & Research Institute
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Olive View-UCLA Education & Research Institute
ClinicalTrials.gov Identifier:
NCT01641029
First received: July 12, 2012
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Pyelonephritis
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Surveillance and Risk Factor Analysis of Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis in the United States

Further study details as provided by Olive View-UCLA Education & Research Institute:

Primary Outcome Measures:
  • Prevalence of antimicrobial resistant E. coli in the U.S. [ Time Frame: July 2013-July 2014 ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
There is no intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641029

Contacts
Contact: Anusha Krishnadasan, PhD 818-364-3111 idnet@ucla.edu

Locations
United States, California
Olive View-UCLA Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Fredrick Abrahamian, DO    818-364-3107      
Sponsors and Collaborators
Olive View-UCLA Education & Research Institute
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Olive View-UCLA Education & Research Institute
ClinicalTrials.gov Identifier: NCT01641029     History of Changes
Other Study ID Numbers: 11H-770351
Study First Received: July 12, 2012
Last Updated: October 15, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Pyelonephritis
Kidney Diseases
Nephritis
Nephritis, Interstitial
Pyelitis
Urologic Diseases
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014