Phase
Condition
Neurologic Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Azienda Ospedaliera Universitaria di San Martino
Genova, 16132
ItalySite Not Available
Ospedale San Martino, Clinica Malattie Infettive
Genova, 16132
ItalySite Not Available
Università di Genova
Genova, 16132
ItalySite Not Available
Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia
Udine, 33100
ItalySite Not Available
Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge
Stockholm, 141 86
SwedenSite Not Available
Pfizer Investigational Site
Stockhom, 141 86
SwedenSite Not Available
St. Bernards Research Center
Jonesboro, Arkansas 72401
United StatesSite Not Available
Pfizer Investigational Site
Boynton Beach, Florida 33426
United StatesSite Not Available
Triple O Research Institute, PA
West Palm Beach, Florida 33401
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
University of Minnesota, Department of Medicine/Division of Infectious Diseases
Minneapolis, Minnesota 55455
United StatesSite Not Available
Drexel University College of Medicine, Partnership Comprehensive Care Practice
Philadelphia, Pennsylvania 19102
United StatesSite Not Available
Associates in Infectious Disease and Tropical Medicine
Pittsburgh, Pennsylvania 15206
United StatesSite Not Available
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