NCT00811980

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

1.4 years

First QC Date

December 17, 2008

Last Update Submit

November 23, 2011

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • IL-6

    Measurement of IL-6 release in response to MRSA.

    12 Months

Secondary Outcomes (1)

  • MCP-1

    12 Months

Study Arms (1)

Heathy Subjects

Drug: Linezolid or Vancomycin

Interventions

Linezolid or VancomycinDRUG

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.

Also known as: Zyvox
Heathy Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects who consent to donate blood.

You may qualify if:

  • Healthy, taking no medications, and not recently hospitalized

You may not qualify if:

  • Infection (active)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Sepsis

Interventions

LinezolidVancomycin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Guy Zimmerman, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 19, 2008

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

November 24, 2011

Record last verified: 2011-11