Overview

This trial is active, not recruiting.

Conditions urinary tract infection, fluoroquinolone, bacteremia
Sponsor University of Pittsburgh
Collaborator Japan Health Sciences Foundation
Start date February 2007
End date December 2016
Trial size 1000 participants
Trial identifier NCT00414362, IRB#0611103, no additional IDs

Summary

The information collected will optimize the management of patients with urinary tract infections with secondary bacteremia, primarily with gram negative bacteria especially Escherichia coli. The current IDSA guideline endorses the use of fluoroquinolones and trimethoprim-sulfamethoxazole as the first line agents. However, over use of this empiric regimen could result in in appropriate treatment of bacteremia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective

Primary Outcomes

Measure
dead or alive
time frame: end of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Clinical information is collected by chart review of "case" and "control" patients. A "case" patient is defined as follows: - One or more blood cultures are positive for Gram-negative bacteria. - The same organism is recovered in urine culture within a 48-hour period. - The organism is ciprofloxacin resistant. - A "control" patient is defined as follows: - One or more blood cultures are positive for Gram-negative bacteria. - The same organism is recovered in urine culture within a 48-hour period. - The organism is ciprofloxacin susceptible. Exclusion Criteria: - negative culture

Additional Information

Official title Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin
Principal investigator Yohei Doi, MD
Description The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Pittsburgh.