Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater

Last updated: June 3, 2015
Sponsor: Pfizer
Overall Status: Terminated

Phase

3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00359632
A5951110
2006-002303-14
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 becurrently 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 linezolidat time of baseline evaluation (or have received linezolid within 7 days of baselineevaluation).

  • Linezolid may be discontinued at any time at the primary physician's discretion andremain 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 similarimportant co-morbidities and epidemiologic factors if possible.

Exclusion

Exclusion Criteria:

  • Subject in Treated Group:

  • Subjects with a known presence of optic or peripheral nerve damage due to anotherillness, condition or medication.

  • Subjects with a pre-existing or a diagnosis at time of screening visit of anophthalmologic 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 toxicityindistinguishable from that caused by linezolid or lactic acidosis.

  • Subjects with a history of significant exposure, in the opinion of the investigatorand with prior discussion with the medical monitor, to medications known to produceoptic or peripheral neuropathy.

  • Subjects with an active communicable disease (i.e., tuberculosis assessed as currentlycommunicable) and subjects on active treatment for tuberculosis or other mycobacterialdisease that include drugs that have known potential to produce ocular or neurologictoxicity.

  • 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 7days at any time.

  • Subjects with a known presence of optic or peripheral nerve damage due to anotherillness, condition or medication.

  • Subjects with a pre-existing or a diagnosis at the screening visit of anophthalmologic 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 hasknown potential to produce ocular or neurologic toxicity indistinguishable from thatcaused by linezolid or lactic acidosis.

  • Subjects with a history of significant exposure, in the opinion of the investigatorand with prior discussion with the medical monitor, to medications known to produceoptic or peripheral neuropathy.

  • Subjects with an active communicable disease (i.e., tuberculosis assessed as currentlycommunicable) and subjects on active treatment for tuberculosis or other mycobacterialdisease that include drugs that have known potential to produce ocular or neurologictoxicity.

Study Design

Total Participants: 34
Study Start date:
November 01, 2008
Estimated Completion Date:
December 31, 2013

Study Description

Characterize Optic Side Effect

Connect with a study center

  • Azienda Ospedaliera Universitaria di San Martino

    Genova, 16132
    Italy

    Site Not Available

  • Ospedale San Martino, Clinica Malattie Infettive

    Genova, 16132
    Italy

    Site Not Available

  • Università di Genova

    Genova, 16132
    Italy

    Site Not Available

  • Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia

    Udine, 33100
    Italy

    Site Not Available

  • Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge

    Stockholm, 141 86
    Sweden

    Site Not Available

  • Pfizer Investigational Site

    Stockhom, 141 86
    Sweden

    Site Not Available

  • St. Bernards Research Center

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Pfizer Investigational Site

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Triple O Research Institute, PA

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • University of Minnesota, Department of Medicine/Division of Infectious Diseases

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Drexel University College of Medicine, Partnership Comprehensive Care Practice

    Philadelphia, Pennsylvania 19102
    United States

    Site Not Available

  • Associates in Infectious Disease and Tropical Medicine

    Pittsburgh, Pennsylvania 15206
    United States

    Site Not Available

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