Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin

Bacteremia Clinical Trial

Official title:

Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414362
• Other study ID #: IRB#0611103
• Secondary ID: no additional ID
• Status: Completed
• Start date: February 2007
• Est. completion date: June 2017

Study information

• Verified date: June 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Fluoroquinolone
• Urinary Tract Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Japan Health Sciences Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dead or alive	health status	end of study