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The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00811980
First Posted: December 19, 2008
Last Update Posted: November 24, 2011
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Utah
  Purpose
We will determine if linezolid inhibits cellular activation and production of pro-inflammatory cytokines, providing mechanistic rationale for its clinical efficacy and the justification for further investigations in S. Aureus sepsis.

Condition Intervention
Sepsis Drug: Linezolid or Vancomycin

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • IL-6 [ Time Frame: 12 Months ]
    Measurement of IL-6 release in response to MRSA.


Secondary Outcome Measures:
  • MCP-1 [ Time Frame: 12 Months ]
    Measurement of MCP-1 release in response to MRSA.


Biospecimen Retention:   Samples Without DNA
Whole blood

Enrollment: 60
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Heathy Subjects Drug: Linezolid or Vancomycin
Whole blood samples from healthy subjects will be incubated with MRSA bacterium or bacterial toxins in the presence and absence of either linezolid or vancomycin. Final concentrations will mimic physiologic conditions. Platelets and leukocytes will be isolated and assayed for the presence of absence of activation and pre-mRNA splicing.
Other Name: Zyvox

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects who consent to donate blood.
Criteria

Inclusion Criteria:

  • Healthy, taking no medications, and not recently hospitalized

Exclusion Criteria:

  • Infection (active)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00811980


Sponsors and Collaborators
University of Utah
Pfizer
Investigators
Principal Investigator: Guy Zimmerman, MD University of Utah
  More Information

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00811980     History of Changes
Other Study ID Numbers: 00392
Pfizer GA5951WK
First Submitted: December 17, 2008
First Posted: December 19, 2008
Last Update Posted: November 24, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Vancomycin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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