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

This study is currently recruiting participants.

Verified by University of Utah, June 2009

First Received: December 17, 2008 Last Updated: June 18, 2009 History of Changes

Sponsor:	University of Utah
Collaborator:	Pfizer
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00811980

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:	Prospective
Official Title:	The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Linezolid Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by University of Utah:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Whole blood

Estimated Enrollment:	30
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2010
Estimated 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811980

Contacts

Contact: Matthew Rondina

801-213-2270

matthew.rondina@hsc.utah.edu

Locations

United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Matthew Rondina, M.D. 801-581-7818 matthew.rondina@hsc.utah.edu
Principal Investigator: Matthew T Rondina, M.D.

Sponsors and Collaborators

University of Utah

Pfizer

Investigators

Principal Investigator:

Guy Zimmerman, MD

University of Utah

More Information

No publications provided

Responsible Party:	University of Utah ( Matthew Rondina, M.D., Co-Investigator )
Study ID Numbers:	00392, Pfizer GA5951WK
Study First Received:	December 17, 2008
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00811980 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Vancomycin
Enzyme Inhibitors
Linezolid
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on February 08, 2010