Study to Evaluate Eye Function in Patients Taking Linezolid for Two Months or Greater
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Optic Nerve Diseases
Intervention: Zyvox - linezolid (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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 two months or longer for the
development of signs or symptoms of visual disturbance or eye disorders
Clinical Details
Official title: Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Two Months Or Greater
Study design: Other, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Primary outcome: To prospectively identify and characterize optic nerve toxicity in subjects receiving long term (2 months or greater) linezolid therapy.
Secondary outcome: To evaluate ophthalmologic screening tests to diagnose optic nerve toxicity; To relate occurrence of toxicity to duration of therapy, mitochondrial genetics and other factors; To assess the overall long-term safety of linezolid.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 two months 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 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 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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Genova 16132, Italy; Recruiting
Pfizer Investigational Site, Torino 10100, Italy; Not yet recruiting
Pfizer Investigational Site, Torino 10149, Italy; Not yet recruiting
Pfizer Investigational Site, Stockholm 141 86, Sweden; Recruiting
Pfizer Investigational Site, Stockhom 141 86, Sweden; Recruiting
Pfizer Investigational Site, Jonesboro, Arkansas 72401, United States; Recruiting
Pfizer Investigational Site, New Orleans, Louisiana 70121, United States; Recruiting
Pfizer Investigational Site, Detroit, Michigan 48202, United States; Recruiting
Pfizer Investigational Site, Detroit, Michigan 48201, United States; Recruiting
Pfizer Investigational Site, Minneapolis, Minnesota 55455, United States; Recruiting
Pfizer Investigational Site, Elkins Park, Pennsylvania 19027, United States; Recruiting
Pfizer Investigational Site, Philadelphia, Pennsylvania 19140, United States; Recruiting
Pfizer Investigational Site, Pittsburgh, Pennsylvania 15206, United States; Recruiting
Pfizer Investigational Site, Pittsburgh, Pennsylvania 15212, United States; Recruiting
Pfizer Investigational Site, Philadelphia, Pennsylvania 19102, United States; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2008
Ending date: July 2011
Last updated: October 16, 2009
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