The Effects of Linezolid and Vancomycin on Inflammation a... | NCT00811980

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

NCT00811980

Sponsor

University of Utah

Status

Completed

Last Update Posted

Nov 24, 2011Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Linezolid or Vancomycin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Pfizer GA5951WK

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Dec 17, 2008

First Submission Date that Met QC Criteria

Dec 18, 2008

First Posted Date

Dec 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2011

Last Update Posted Date

Nov 24, 2011Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heathy Subjects			Drug: Linezolid or Vancomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linezolid or Vancomycin	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IL-6	Measurement of IL-6 release in response to MRSA.	12 Months

Secondary Outcomes

Measure	Description	Time Frame
MCP-1	Measurement of MCP-1 release in response to MRSA.	12 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, taking no medications, and not recently hospitalized

Exclusion Criteria:

Infection (active)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy subjects who consent to donate blood.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Guy Zimmerman, MD	University of Utah	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069349	Linezolid
D014640	Vancomycin

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144

Browse Leaves

Not provided

Browse Branches

Not provided