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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary: Characterize Optic Side Effect
Sponsor: Pfizer

Current Primary Outcome: Percentage of Participants With an Adverse Event [ Time Frame: Through and including 28 calendar days after the last administration of the investigational product ]

Original Primary Outcome: To prospectively identify optic nerve toxicity in subjects receiving long term (2 months or greater) linezolid therapy.

Current Secondary Outcome: Percentage of Participants by Clinical Outcome of Infection at End of Study [ Time Frame: At End of Study visit ]

Clinical response was evaluated at the End of Study visit (30 days after last dose) as Cure, Improvement, Failure, Unknown or Other. Clinical response was based primarily on the global assessment of the clinical presentation of the subject made by the investigator at that evaluation timepoint. The clinical response classifications were defined as follows. Cure: Resolution of the clinical signs and symptoms of infection, when compared to Baseline. No additional antimicrobial treatment is required for the disease under study. Improvement: Improvement in 2 or more, but not all, of the clinical signs and symptoms of infection, when compared with Baseline. No additional antimicrobial treatment is required for the disease under study. Failure: Persistence or progression of Baseline clinical signs and symptoms of infection, or development of new clinical findings consistent with active infection. Unknown: Inability to assess clinical response.


Original Secondary Outcome:

  • To examine the association of abnormal ophthalmologic screening tests suggesting the presence of optic nerve toxicity with neuro-ophthalmologic tests confirming optic nerve toxicity
  • To examine the reversibility of any optic nerve toxicity
  • To evaluate newer research ophthalmologic testing in the assessment of optic neuropathy
  • To relate occurrence of toxicity to duration of therapy, mitochondrial genetics, co-morbid conditions and other epidemiologic factors
  • To assess the overall long-term safety of linezolid including development of peripheral neuropathy and lactic acidosis


Information By: Pfizer

Dates:
Date Received: July 28, 2006
Date Started: November 2008
Date Completion:
Last Updated: June 3, 2015
Last Verified: June 2015