Ampicillin-sulbactam Resistant E.Coli at UPMC

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.

Study Overview

• Status: Withdrawn
• Conditions: Positive E Coli Infections

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

E coli positive infections at UPMC

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
positive E coli; positive E coli at UPMC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The aims of this study are to: Determine the risk factors for multidrug resistance (ESBL production) in bloodstream isolates of Gram negative bacilli,	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
determine the risk factors for failure of prompt clearance of the blood of Gram negative bacteria	5 years

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Yohei Doi, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 7, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (Estimate): February 21, 2008

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: E coli
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Escherichia coli Infections
• Other Study ID Numbers: PRO08010298