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

Study Description

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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.

Condition or disease
Urinary Tract Infection; Fluoroquinolone; 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.

Study Design

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Study Type :	Observational
Actual Enrollment :	1000 participants
Observational Model:	Other
Time Perspective:	Retrospective
Official Title:	Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin
Actual Study Start Date :	February 2007
Actual Primary Completion Date :	June 2017
Actual Study Completion Date :	June 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. dead or alive [ Time Frame: end of study ]
   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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00414362 History of Changes
Other Study ID Numbers:	IRB#0611103; no additional IDs
First Posted:	December 21, 2006
Last Update Posted:	June 26, 2017
Last Verified:	June 2017

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