Towards Reducing Resistance and Hematological Toxicity of Linezolid

Completed

Conditions studied: Infection, Adverse Effects

In brief

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.

Key facts

Study ID

NCT00177723

Run by

University of Pittsburgh

People needed

50

Starts

2005-08-01

Expected to finish

2007-02-01

Last updated by the study team

2008-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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