Ampicillin-Sulbactam Resistant E.Coli at UPMC
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Positive E Coli Infections
Phase: N/A
Status: Recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
Yohei Doi, MD, Principal Investigator, Affiliation: UPMC
Overall contact:
Yohei Doi, MD, Phone: 412-648-6557, Email: doiy@upmc.edu
Summary
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.
Clinical Details
Official title: Ampicillin-Sulbactam Resistant E.Coli at UPMC
Study design: Cohort, Retrospective
Primary outcome: The aims of this study are to: Determine the risk factors for multidrug resistance (ESBL production) in bloodstream isolates of Gram negative bacilli,
Secondary outcome: determine the risk factors for failure of prompt clearance of the blood of Gram negative bacteria
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Yohei Doi, MD, Phone: 412-648-6557, Email: doiy@upmc.edu
UPMC, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Yohei Doi, MD, Phone: 412-648-6557, Email: doiy@upmc.edu
Diana Pakstis, RN, BSN, Phone: 412-648-6553, Email: paksitsdl@dom.pitt.edu
Yohei Doi, MD, Principal Investigator
Additional Information
Starting date: February 2008
Last updated: October 3, 2008
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