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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00359632 |
Purpose
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 |
|---|---|---|
|
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: | November 2008 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (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.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
| United States, Arkansas | |
| Pfizer Investigational Site | Recruiting |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, Florida | |
| Pfizer Investigational Site | Recruiting |
| Boynton Beach, Florida, United States, 33426 | |
| Pfizer Investigational Site | Recruiting |
| West Palm Beach, Florida, United States, 33401 | |
| Pfizer Investigational Site | Not yet recruiting |
| Fort Lauderdale, Florida, United States, 33312 | |
| Pfizer Investigational Site | Not yet recruiting |
| Plantation, Florida, United States, 33317 | |
| United States, Louisiana | |
| Pfizer Investigational Site | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Michigan | |
| Pfizer Investigational Site | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Pfizer Investigational Site | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| 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 | |
| Pfizer Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Italy | |
| Pfizer Investigational Site | Recruiting |
| Genova, Italy, 16132 | |
| Pfizer Investigational Site | Not yet recruiting |
| Torino, Italy, 10100 | |
| Pfizer Investigational Site | Not yet recruiting |
| Torino, Italy, 10149 | |
| Sweden | |
| Pfizer Investigational Site | Recruiting |
| Stockholm, Sweden, 141 86 | |
| Pfizer Investigational Site | Recruiting |
| Stockhom, Sweden, 141 86 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A5951110 |
| Study First Received: | July 28, 2006 |
| Last Updated: | January 14, 2010 |
| ClinicalTrials.gov Identifier: | NCT00359632 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Optic neuropathy following long-term linezolid use |
|
Protein Synthesis Inhibitors Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Eye Diseases Nervous System Diseases |
Enzyme Inhibitors Optic Nerve Diseases Cranial Nerve Diseases Linezolid Pharmacologic Actions |