Gram Negative Bacteremia, Risk Factors for Failure of Therapy



Status:Completed
Conditions:Infectious Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:6/10/2017
Start Date:April 2005
End Date:May 2016

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The aims of this study are to:

- Determine the risk factors for multidrug resistance in bloodstream isolates of Gram
negative bacilli

- Determine the mechanisms of multidrug resistance in bloodstream isolates of Gram
negative bacilli

- Determine the risk factors for failure of prompt clearance of the blood of Gram
negative bacteria

- Determine the survival of patients with Gram negative bacteremia

- Determine if failure of prompt clearance of the blood of Gram negative bacteria is a
predictor of mortality following this infection

The following variables will be followed: 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 identifiers.

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:
We found this trial at
1
site
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Yohei Doi, MD
Phone: 412-648-6445
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, PA
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