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Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin
This study is currently recruiting participants.
Verified by University of Pittsburgh, December 2008
Sponsors and Collaborators: University of Pittsburgh
Japan Health Sciences Foundation
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00414362
  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

MedlinePlus related topics: Urinary Tract Infections
U.S. FDA Resources
Study Type: Observational
Study Design: Retrospective
Official Title: Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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 2012
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414362

Contacts
Contact: Yohei Doi, MD 412-648-6401 doiy@dom.pitt.edu
Contact: David L Paterson, MD 412-648-6401 Patersond@dom.pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Diana Pakstis, RN, BSN     412-648-6553     pakstisdl@dom.pitt.edu    
Contact: Mary Ellen Carey, RN, BSN     412-648-6453     cheswickm@dom.pitt.edu    
Principal Investigator: David L Paterson, MD            
Principal Investigator: Yohei Doi, MD            
Sponsors and Collaborators
University of Pittsburgh
Japan Health Sciences Foundation
Investigators
Principal Investigator: Yohei Doi, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: UPMC ( Yohei Doi, MD )
Study ID Numbers: IRB#0611103, no additional IDs
Study First Received: December 19, 2006
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00414362  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Bacterial Infections
Sepsis
Fluoroquinolones
Urologic Diseases
Urinary Tract Infections
Bacteremia
Inflammation

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Infection
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009