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

This study has been completed.

First Received on December 17, 2008. Last Updated on November 23, 2011 History of Changes

Sponsor:	University of Utah
Collaborator:	Pfizer
Information provided by (Responsible Party):	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:	Time Perspective: 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: Vancomycin Vancomycin hydrochloride Linezolid

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

IL-6 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Measurement of IL-6 release in response to MRSA.

Secondary Outcome Measures:

MCP-1 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
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

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

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
ClinicalTrials.gov Identifier:	NCT00811980 History of Changes
Other Study ID Numbers:	00392, Pfizer GA5951WK
Study First Received:	December 17, 2008
Last Updated:	November 23, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Inflammation
Sepsis
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Vancomycin
Linezolid

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012