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

Last updated on March 14, 2019

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Study Location
St. Bernards Research Center
Jonesboro, Arkansas, 72401 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Optic Nerve Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00359632
Pfizer
Terminated
Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater

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