NCT00359632

Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater

Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Six Weeks Or Greater

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To understand and characterize the effects of linezolid on the optic nerve by observing and following patients who have been treated with linezolid for six weeks or longer for the development of signs or symptoms of visual disturbance or eye disorders.

Detailed description

Characterize Optic Side Effect

Conditions

• Optic Nerve Diseases

Interventions

Type	Name	Description
DRUG	Zyvox - linezolid	Observation and testing in patients for whom their treating physician has determined linezolid is an appropriate therapy. Eye tests performed for subjects who have received linezolid for at least 6 weeks and matching controls who have received other antibiotics for similar types of infections.
DRUG	Matched control	Matched controls received an antibiotic other than linezolid for at least 6 weeks prior to baseline visit. The control group had only a baseline visit and there were no post baseline study visits.

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2006-08-02
• Last updated: 2015-06-26
• Results posted: 2015-06-26

Locations

12 sites across 3 countries: United States, Italy, Sweden