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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Japan Health Sciences Foundation
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00414362
First received: December 19, 2006
Last updated: December 16, 2015
Last verified: December 2015
History of Changes
  Purpose
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.

Condition
Urinary Tract Infection
Fluoroquinolone
Bacteremia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • dead or alive [ Time Frame: end of study ] [ Designated as safety issue: No ]
    health status


Biospecimen Retention:   Samples Without DNA
No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.

Estimated Enrollment: 1000
Study Start Date: February 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
postive gram negative culture
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
  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: NCT00414362

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Japan Health Sciences Foundation
Investigators
Principal Investigator: Yohei Doi, MD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00414362     History of Changes
Other Study ID Numbers: IRB#0611103  no additional IDs 
Study First Received: December 19, 2006
Last Updated: December 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Bacteremia
Urinary Tract Infections
Fluoroquinolone

Additional relevant MeSH terms:
Urinary Tract Infections
Bacteremia
Infection
Urologic Diseases
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016