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:

MedlinePlus related topics: Urinary Tract Infections

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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.


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)
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

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

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 June 23, 2017

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