NCT00177723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

December 17, 2008

Status Verified

December 1, 2008

First QC Date

September 13, 2005

Last Update Submit

December 16, 2008

Conditions

InfectionAdverse Effects

Keywords

receiving antibiotic Linezolid clinically

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

  • David L Paterson, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

August 1, 2005

Study Completion

February 1, 2007

Last Updated

December 17, 2008

Record last verified: 2008-12

Locations

US(1)