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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00359632 |
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
Condition | Intervention | Phase |
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Optic Nerve Diseases |
Drug: Zyvox - linezolid |
Phase III |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Two Months Or Greater |
Estimated Enrollment: | 60 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Linezolid: Experimental
Subjects have received at least 2 months of linezolid therapy (600 mg BID). Continued duration of linezolid treatment is based on treating physician's benefit/risk assessment. A matching control who did not receive linezolid will be selected for each linezolid treated subject.
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Drug: Zyvox - linezolid
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 2 months and matching controls who have received other antibiotics for similar types of infections.
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Characterize Optic Side Effect
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, Arkansas | |
Pfizer Investigational Site | Recruiting |
Jonesboro, Arkansas, United States, 72401 | |
United States, Michigan | |
Pfizer Investigational Site | Recruiting |
Detroit, Michigan, United States, 48202 | |
United States, Minnesota | |
Pfizer Investigational Site | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
United States, Pennsylvania | |
Pfizer Investigational Site | Recruiting |
Elkins Park, Pennsylvania, United States, 19027 | |
Pfizer Investigational Site | Recruiting |
Philadelphia, Pennsylvania, United States, 19140 | |
Pfizer Investigational Site | Recruiting |
Pittsburgh, Pennsylvania, United States, 15206 | |
Pfizer Investigational Site | Recruiting |
Pittsburgh, Pennsylvania, United States, 15212 | |
Italy | |
Pfizer Investigational Site | Not yet recruiting |
Genova, Italy, 16132 | |
Pfizer Investigational Site | Not yet recruiting |
Torino, Italy, 10149 | |
Sweden | |
Pfizer Investigational Site | Not yet recruiting |
Stockholm, Sweden, 141 86 | |
Pfizer Investigational Site | Not yet recruiting |
Stockhom, Sweden, 141 86 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5951110 |
Study First Received: | July 28, 2006 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00359632 |
Health Authority: | United States: Food and Drug Administration |
Optic neuropathy following long-term linezolid use |
Eye Diseases Optic Nerve Diseases Linezolid Optic nerve disorder |
Protein Synthesis Inhibitors Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Nervous System Diseases Enzyme Inhibitors Cranial Nerve Diseases Pharmacologic Actions |