Towards Reducing Resistance and Hematological Toxicity of Linezolid

This study has been completed.

Sponsors and Collaborators:	University of Pittsburgh Monash University
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177723

Purpose

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	Phase
Infection Adverse Effects	Phase IV

Drug Information available for: Linezolid

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Towards Reducing Resistance and Hematological Toxicity of Linezolid

Further study details as provided by University of Pittsburgh:

Estimated Enrollment:	50
Study Start Date:	August 2005
Study Completion Date:	February 2007

Show Detailed Description

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177723

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Monash University

Investigators

Principal Investigator:

David L Paterson, MD

University of Pittsburgh

More Information

Study ID Numbers:	IRB# 0501019
Study First Received:	September 13, 2005
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00177723
Health Authority:	United States: Institutional Review Board; Australia: National Health and Medical Research Council

Keywords provided by University of Pittsburgh:

receiving antibiotic Linezolid clinically

Study placed in the following topic categories:

Linezolid

Additional relevant MeSH terms:

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

Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009