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OpenTrials
Completed

NCT Number: NCT00414362

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. dead or alive

    Time frame: end of study

    health status

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Japan Health Sciences Foundation

Registry information

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2006
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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