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



Status:Completed
Conditions:Neurology, Ocular
Therapuetic Areas:Neurology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:November 2008
End Date:January 2014
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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

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.

Characterize Optic Side Effect

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.
We found this trial at
9
sites
Jonesboro, Arkansas 72401
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Boynton Beach, Florida 33472
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Detroit, Michigan 48202
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Detroit, MI
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Minneapolis, Minnesota 55422
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Minneapolis, MN
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New Orleans, Louisiana 70121
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New Orleans, LA
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Philadelphia, Pennsylvania 19134
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15212
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Pittsburgh, Pennsylvania 15212
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Pittsburgh, PA
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West Palm Beach, Florida 33409
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West Palm Beach, FL
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