Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00359632
First received: July 28, 2006
Last updated: May 22, 2013
Last verified: May 2013
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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 six weeks 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 3 |
| 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 Six Weeks Or Greater |
Resource links provided by NLM:
MedlinePlus related topics:
Neurologic Diseases
Drug Information available for:
Linezolid
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To prospectively identify and characterize optic nerve toxicity in subjects receiving long term (6 weeks or greater) linezolid therapy. [ Time Frame: Up to 1 year after end of therapy ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: Up to 1 year after end of therapy ] [ Designated as safety issue: Yes ]
| 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 6 weeks 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 6 weeks and matching controls who have received other antibiotics for similar types of infections.
|
Detailed Description:
Characterize Optic Side Effect
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359632
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| 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, 48202 | |
| United States, Minnesota | |
| Pfizer Investigational Site | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Terminated |
| 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 | |
| Pfizer Investigational Site | Recruiting |
| Udine, Italy, 33100 | |
| Sweden | |
| Pfizer Investigational Site | Recruiting |
| Stockholm, Sweden, 141 86 | |
| Pfizer Investigational Site | Recruiting |
| Stockhom, Sweden, 141 86 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00359632 History of Changes |
| Other Study ID Numbers: | A5951110 |
| Study First Received: | July 28, 2006 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Optic neuropathy following long-term linezolid use |
Additional relevant MeSH terms:
|
Nervous System Diseases Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases Linezolid Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013