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

NCT00414362 | Completed DMC

• 2 other identifiers: IRB#0611103no additional IDs
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection; Fluoroquinolone; Bacteremia

Keywords

Bacteremia; Urinary Tract Infections; Fluoroquinolone

Outcome Measures

Primary Outcomes (1)

• dead or alive

  health status

  end of study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

postive gram negative culture

You may qualify if:

• 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.

You may not qualify if:

• negative culture

Sponsors & Collaborators

• University of Pittsburgh: lead
• Japan Health Sciences Foundation: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

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.

MeSH Terms

Conditions

Urinary Tract Infections; Bacteremia

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yohei Doi, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: February 1, 2007
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

US (1)