|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Pfizer |
|---|---|
| Information provided by (Responsible Party): | 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: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| 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: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Linezolid
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.
|
Characterize Optic Side Effect
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 | Terminated |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, Florida | |
| Pfizer Investigational Site | Terminated |
| Boynton Beach, Florida, United States, 33426 | |
| Pfizer Investigational Site | Terminated |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Louisiana | |
| Pfizer Investigational Site | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Michigan | |
| Pfizer Investigational Site | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| 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 |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Pfizer Investigational Site | Terminated |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Pfizer Investigational Site | Terminated |
| Pittsburgh, Pennsylvania, United States, 15206 | |
| Italy | |
| Pfizer Investigational Site | Recruiting |
| Genova, Italy, 16132 | |
| 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 |
| ClinicalTrials.gov Identifier: | NCT00359632 History of Changes |
| Other Study ID Numbers: | A5951110 |
| Study First Received: | July 28, 2006 |
| Last Updated: | January 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Optic neuropathy following long-term linezolid use |
|
Optic Nerve Diseases Cranial Nerve Diseases Nervous System Diseases Eye Diseases Linezolid Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |