Official Title: “Gram Negative Bacteremia, Risk Factors for Failure of Therapy”

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

Study Type: Observational

Study Design: Other, Prospective

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:

• None

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

David Paterson, MD Principal Investigator University of Pittsburgh  

Overall Contact: David Paterson, MD 412-648-1401 patersond@dom.pitt.edu

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177957

Study ID Number: IRB # 0504090

ClinicalTrials.gov Identifier: NCT00177957

Health Authority: United States: Institutional Review Board