Clinical trial NCT00414362: Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin
Official title: Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection
Fluoroquinolone
Bacteremia
Keywords: Bacteremia
Urinary Tract Infections
Fluoroquinolone
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Japan Health Sciences Foundation
First posted: 2006-12-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: postive gram negative culture

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: dead or alive
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Yohei Doi, MD
role: PRINCIPAL_INVESTIGATOR
References: