Clinical trial NCT00359632: Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater
Official title: Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Six Weeks Or Greater
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Optic Nerve Diseases
Keywords: Optic neuropathy following long-term linezolid use
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed description: Characterize Optic Side Effect

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With an Adverse Event
timeFrame: Through and including 28 calendar days after the last administration of the investigational product
Secondary outcomes:
measure: Percentage of Participants by Clinical Outcome of Infection at End of Study
timeFrame: At End of Study visit
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: St. Bernards Research Center
state: Arkansas
city: West Palm Beach
country: United States
facility: Triple O Research Institute, PA
state: Florida
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota, Department of Medicine/Division of Infectious Diseases
state: Minnesota
city: Philadelphia
country: United States
facility: Drexel University College of Medicine, Partnership Comprehensive Care Practice
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Associates in Infectious Disease and Tropical Medicine
state: Pennsylvania
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria di San Martino
city: Genova
country: Italy
facility: Ospedale San Martino, Clinica Malattie Infettive
city: Genova
country: Italy
facility: Università di Genova
city: Udine
country: Italy
facility: Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia
city: Stockholm
country: Sweden
facility: Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: