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Study to Evaluate Eye Function in Patients Taking Linezolid for Two Months or Greater

This study is currently recruiting participants.
Verified by Pfizer, October 2008

Sponsored by: 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

Drug Information available for:   Linezolid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To prospectively identify and characterize optic nerve toxicity in subjects receiving long term (2 months 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:   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.
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

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 two months 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 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 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, Michigan
Pfizer Investigational Site     Recruiting
      Detroit, Michigan, United States, 48202
United States, Pennsylvania
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

Sponsors and Collaborators
Pfizer

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer    
  More Information


To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:   A5951110
First Received:   July 28, 2006
Last Updated:   October 20, 2008
ClinicalTrials.gov Identifier:   NCT00359632
Health Authority:   United States: Food and Drug Administration

Keywords provided by Pfizer:
Optic neuropathy following long-term linezolid use  

Study placed in the following topic categories:
Eye Diseases
Optic Nerve Diseases
Linezolid
Optic nerve disorder

Additional relevant MeSH terms:
Protein Synthesis Inhibitors
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Nervous System Diseases
Enzyme Inhibitors
Cranial Nerve Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 04, 2008




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