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.
Characterize Optic Side Effect
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
34
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.
Matched controls received an antibiotic other than linezolid for at least 6 weeks prior to baseline visit. The control group had only a baseline visit and there were no post baseline study visits.
St. Bernards Research Center
Jonesboro, Arkansas, United States
Triple O Research Institute, PA
West Palm Beach, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Percentage of Participants With an Adverse Event
Time frame: Through and including 28 calendar days after the last administration of the investigational product
Percentage of Participants by Clinical Outcome of Infection at End of Study
Clinical response was evaluated at the End of Study visit (30 days after last dose) as Cure, Improvement, Failure, Unknown or Other. Clinical response was based primarily on the global assessment of the clinical presentation of the subject made by the investigator at that evaluation timepoint. The clinical response classifications were defined as follows. Cure: Resolution of the clinical signs and symptoms of infection, when compared to Baseline. No additional antimicrobial treatment is required for the disease under study. Improvement: Improvement in 2 or more, but not all, of the clinical signs and symptoms of infection, when compared with Baseline. No additional antimicrobial treatment is required for the disease under study. Failure: Persistence or progression of Baseline clinical signs and symptoms of infection, or development of new clinical findings consistent with active infection. Unknown: Inability to assess clinical response.
Time frame: At End of Study visit
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Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota, Department of Medicine/Division of Infectious Diseases
Minneapolis, Minnesota, United States
Drexel University College of Medicine, Partnership Comprehensive Care Practice
Philadelphia, Pennsylvania, United States
Associates in Infectious Disease and Tropical Medicine
Pittsburgh, Pennsylvania, United States
Azienda Ospedaliera Universitaria di San Martino
Genova, Italy
Ospedale San Martino, Clinica Malattie Infettive
Genova, Italy
Università di Genova
Genova, Italy
...and 2 more locations