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Gram Negative Bacteremia, Risk Factors for Failure of Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177957
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 9, 2017
PI discretionary funding
Information provided by (Responsible Party):
Yohei Doi, University of Pittsburgh

Brief Summary:

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

Condition or disease
Gram-Negative Bacterial Infections

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gram Negative Bacteremia, Risk Factors for Failure of Therapy
Study Start Date : April 2005
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Primary Outcome Measures :
  1. outcome of dead or alive post treatment [ Time Frame: December 2020 ]
    dead or alive

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with gram negative bacteremia

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177957

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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
PI discretionary funding
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Principal Investigator: Yohei Doi, MD University of Pittsburgh
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Responsible Party: Yohei Doi, Associate Professor, University of Pittsburgh Identifier: NCT00177957    
Other Study ID Numbers: IRB # 0504090
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yohei Doi, University of Pittsburgh:
Gram negative bacteremia
Additional relevant MeSH terms:
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Bacterial Infections
Gram-Negative Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes