Ampicillin-sulbactam Resistant E.Coli at UPMC
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The information collected will optimize the management of patients with gram negative bacteremia. Approximately 300 patients with Gram negative bacteremia are cared for each year at UPMC-P. Published medical literature suggests that mortality from this infection exceeds 20%. The aim of this research is to determine the risk factors for bacteriologic failure of antibiotic therapy, risk factors for antibiotic resistance in bloodstream isolates and risk factors for mortality from Gram negative bacteremia. Modifiable risk factors can then be tackled by a future interventional study.
| Condition |
|---|
|
Positive E Coli Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Ampicillin-sulbactam Resistant E.Coli at UPMC |
- The aims of this study are to: Determine the risk factors for multidrug resistance (ESBL production) in bloodstream isolates of Gram negative bacilli, [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- determine the risk factors for failure of prompt clearance of the blood of Gram negative bacteria [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2015 |
| Groups/Cohorts |
|---|
|
positive E coli
positive E coli at UPMC
|
Detailed Description:
The information collected will optimize the management of patients with gram negative bacteremia. Approximately 300 patients with Gram negative bacteremia are cared for each year at UPMC-P. All sites are collecting the following information that was collected as part of the patient's clinical treatment. The following variables will be collected at all sites: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, laboratory and radiographical data, antimicrobial usage within 14 days of onset of bacteremia, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of bacteremia, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history (please see attached clinical data collection worksheet dated 4/2005). We will also collect information retrospectively for one year and prospectively for one year. The bacteria in the patient's blood cultures will be subcultured (after the diagnosis has been obtained since the microbiology lab would otherwise destroy the culture) and provided to the honest broker who will deidentify the specimen and link it to the medical information collected (which will also be deidentified by the honest broker). The following evaluation will be performed on these samples. The minimal inhibitory concentration of the antibiotic used in treatment will be performed by the E-Test method (AB Biodisk, Solna, Sweden). Specific mechanisms of antimicrobial resistance will be studied with emphasis on the presence of beta-lactamases produced by the bacteria. This evaluation will be performed by analytical isoelectric focusing techniques as well as PCR and gene sequencing analysis to determine genes encoding beta-lactamases. Biologic samples will be under the control of the principal investigator of this research project. All samples provided to the investigators are deidentified by the honest broker and will be coded with numbers. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location that only the honest broker has access to. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. At no time with the research investigators have access to any patient identifers. Medical record information and bacteria samples from facilities outside of UPMC will be provided to the PI de-identified. At not time will the anyone on the research team have access to patient identifiers. All information and bacteria are collected as part of the patient's clinical treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
E coli positive infections at UPMC
Inclusion Criteria:
- All patients at the aforementioned institutions that have Gram negative bacteremia will be included in the study.
- Women with childbearing potential will also be included in this study. Since this is an observational study, no added risk is conferred to the woman or potential progeny. HIV serostatus will not be specifically investigated for participation in this study.
Exclusion Criteria:
- None
Contacts and Locations
More Information
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00619580 History of Changes |
| Other Study ID Numbers: | PRO08010298 |
| Study First Received: | February 7, 2008 |
| Last Updated: | August 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
E coli |
Additional relevant MeSH terms:
|
Escherichia coli Infections Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Ampicillin Sulbactam Sultamicillin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013