Time To Efficacy and Onset Of Action Of Linezolid

This study has been completed.

First Received on September 2, 2005. Last Updated on May 9, 2011 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00147511

Purpose

To assess the onset of action of linezolid

Condition	Intervention	Phase
Gram-Positive Bacterial Infections Skin and Connective Tissue Diseases	Drug: linezolid	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Time To Efficacy and Onset Of Action Of Linezolid In Skin and Soft Tissue Infections

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Connective Tissue Disorders

Drug Information available for: Linezolid

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Time to defervescence

Secondary Outcome Measures:

Reduction of CRP levels Reduction of leucocyte count

Enrollment:	118
Study Start Date:	June 2003
Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

suspected grampositive infection
fever > 38 C

Exclusion Criteria:

Infections to be treated successfully by surgical procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147511

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier:	NCT00147511 History of Changes
Other Study ID Numbers:	OXAA-0026-162
Study First Received:	September 2, 2005
Last Updated:	May 9, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Bacterial Infections
Connective Tissue Diseases
Gram-Positive Bacterial Infections
Soft Tissue Infections
Infection
Linezolid

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

ClinicalTrials.gov processed this record on February 09, 2012