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Trial record 1 of 1 for:    NCT00811980
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The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents

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ClinicalTrials.gov Identifier: NCT00811980
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : November 24, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Utah

Tracking Information
First Submitted Date December 17, 2008
First Posted Date December 19, 2008
Last Update Posted Date November 24, 2011
Study Start Date January 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2011)
IL-6 [ Time Frame: 12 Months ]
Measurement of IL-6 release in response to MRSA.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: November 23, 2011)
MCP-1 [ Time Frame: 12 Months ]
Measurement of MCP-1 release in response to MRSA.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents
Official Title The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood
Sampling Method Non-Probability Sample
Study Population Healthy subjects who consent to donate blood.
Condition Sepsis
Intervention 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
Study Groups/Cohorts Heathy Subjects
Intervention: Drug: Linezolid or Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 23, 2011)
60
Original Estimated Enrollment
 (submitted: December 18, 2008)
30
Actual Study Completion Date June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Healthy, taking no medications, and not recently hospitalized

Exclusion Criteria:

  • Infection (active)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00811980
Other Study ID Numbers 00392
Pfizer GA5951WK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Utah
Study Sponsor University of Utah
Collaborators Pfizer
Investigators
Principal Investigator: Guy Zimmerman, MD University of Utah
PRS Account University of Utah
Verification Date November 2011