Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin
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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 |
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 2015 |
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 |
postive gram negative culture
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| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Yohei Doi, MD | University of Pittsburgh |
More Information
No publications provided
| 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: | August 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Bacteremia Urinary Tract Infections Fluoroquinolone |
Additional relevant MeSH terms:
|
Bacteremia Urinary Tract Infections Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Urologic Diseases |
Fluoroquinolones Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013