Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater
Condition: Optic Nerve Diseases
MeSH terms: Nervous System Diseases; Optic Nerve Diseases
Intervention: Zyvox - linezolid; Matched control
Intervention description: 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.; 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.
Intervention MeSH terms: Linezolid
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Optic neuropathy following long-term linezolid use

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects who are 18 years of age or older.

          -  Subjects in Treated Group:

          -  Subjects must have received linezolid 600 mg BID for six weeks or greater and be
             currently on drug (or have received linezolid within 7 days of baseline evaluation).

          -  Subjects who have current signs or symptoms compatible with linezolid toxicity (i.e.
             optic or peripheral neuropathy) may be enrolled in the study if they are on linezolid
             at time of baseline evaluation (or have received linezolid within 7 days of baseline
             evaluation).

          -  Linezolid may be discontinued at any time at the primary physician's discretion and
             remain on the study.

          -  Women of childbearing potential must use adequate contraception

          -  Subjects in Control Group:

          -  Subjects will have a diagnosis similar to patients in the treated group and similar
             important co-morbidities and epidemiologic factors if possible.

        Exclusion Criteria:

          -  Subject in Treated Group:

          -  Subjects with a known presence of optic or peripheral nerve damage due to another
             illness, condition or medication.

          -  Subjects with a pre-existing or a diagnosis at time of screening visit of an
             ophthalmologic condition that would adversely affect the study testing protocol (e.g.
             dense cataracts, macular degeneration, retinitis pigmentosa).

          -  Subjects who are currently receiving or anticipated to receive another medication,
             antibiotic or other, that has known potential to produce ocular or neurologic toxicity
             indistinguishable from that caused by linezolid or lactic acidosis.

          -  Subjects with a history of significant exposure, in the opinion of the investigator
             and with prior discussion with the medical monitor, to medications known to produce
             optic or peripheral neuropathy.

          -  Subjects with an active communicable disease (i.e., tuberculosis assessed as currently
             communicable) and subjects on active treatment for tuberculosis or other mycobacterial
             disease that include drugs that have known potential to produce ocular or neurologic
             toxicity.

          -  Subjects with severe liver disease or abnormal liver function test.

          -  Subjects in Control Group:

          -  Subjects must not currently be taking linezolid or have received it for more than 7
             days at any time.

          -  Subjects with a known presence of optic or peripheral nerve damage due to another
             illness, condition or medication.

          -  Subjects with a pre-existing or a diagnosis at the screening visit of an
             ophthalmologic condition that would adversely affect the study testing protocol (e.g.
             dense cataracts, macular degeneration, retinitis pigmentosa).

          -  Subjects who are currently receiving another medication, antibiotic or other, that has
             known potential to produce ocular or neurologic toxicity indistinguishable from that
             caused by linezolid or lactic acidosis.

          -  Subjects with a history of significant exposure, in the opinion of the investigator
             and with prior discussion with the medical monitor, to medications known to produce
             optic or peripheral neuropathy.

          -  Subjects with an active communicable disease (i.e., tuberculosis assessed as currently
             communicable) and subjects on active treatment for tuberculosis or other mycobacterial
             disease that include drugs that have known potential to produce ocular or neurologic
             toxicity.