Towards Reducing Resistance and Hematological Toxicity of Linezolid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177723
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 17, 2008
Monash University
Information provided by:
University of Pittsburgh

Brief Summary:
The study will evaluate and improve the performance of pharmaco-statistical models previously developed in the compassionate use program in patients being treated with linezolid under clinical usage conditions. This study will also develop a sensitive and specific tool that may be used to predict patients at risk of hematological toxicity, based on factors including linezolid concentration and duration of therapy and use these models to better understand the determinants of toxicity with linezolid and define better strategies to manage toxicity or reduce its occurrence.

Condition or disease
Infection Adverse Effects

  Show Detailed Description

Study Type : Observational
Enrollment : 50 participants
Time Perspective: Prospective
Official Title: Towards Reducing Resistance and Hematological Toxicity of Linezolid
Study Start Date : August 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males or females greater than 18 years of age.
  • All patients will remain in the hospital for pharmacokinetic sampling.
  • All subjects must be on the medication linezolid as part of their standard of care.

Exclusion Criteria:

  • Patients with renal failure who receive peritoneal dialysis, hemodialysis or hemofiltration.
  • Any contraindication to blood sampling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177723

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Monash University
Principal Investigator: David L Paterson, MD University of Pittsburgh Identifier: NCT00177723     History of Changes
Other Study ID Numbers: IRB# 0501019
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 17, 2008
Last Verified: December 2008

Keywords provided by University of Pittsburgh:
receiving antibiotic Linezolid clinically

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action