Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Optic Nerve Diseases
Intervention: Zyvox - linezolid (Drug); Matched control (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Six Weeks Or Greater
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Percentage of Participants With an Adverse Event
Secondary outcome: Percentage of Participants by Clinical Outcome of Infection at End of Study
Detailed description:
Characterize Optic Side Effect
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 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.
Locations and Contacts
Azienda Ospedaliera Universitaria di San Martino, Genova 16132, Italy
Ospedale San Martino, Clinica Malattie Infettive, Genova 16132, Italy
Università di Genova, Genova 16132, Italy
Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine 33100, Italy
Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge, Stockholm 141 86, Sweden
St. Bernards Research Center, Jonesboro, Arkansas 72401, United States
Triple O Research Institute, PA, West Palm Beach, Florida 33401, United States
Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States
Henry Ford Health System, Detroit, Michigan 48202, United States
University of Minnesota, Department of Medicine/Division of Infectious Diseases, Minneapolis, Minnesota 55455, United States
Drexel University College of Medicine, Partnership Comprehensive Care Practice, Philadelphia, Pennsylvania 19102, United States
Associates in Infectious Disease and Tropical Medicine, Pittsburgh, Pennsylvania 15206, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2008
Last updated: June 3, 2015
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