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

Optic Nerve Diseases Clinical Trial

Official title:

Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Six Weeks Or Greater

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00359632
• Other study ID #: A5951110
• Secondary ID: 2006-002303-14
• Status: Terminated
• Phase: Phase 3
• First received: July 28, 2006
• Last updated: June 3, 2015
• Start date: November 2008
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Characterize Optic Side Effect

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Nervous System Diseases
• Optic Nerve Diseases

Intervention

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 6 weeks and matching controls who have received other antibiotics for similar types of infections.
• Matched control
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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria di San Martino	Genova
Italy	Ospedale San Martino, Clinica Malattie Infettive	Genova
Italy	Università di Genova	Genova
Italy	Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia	Udine
Sweden	Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge	Stockholm
United States	Henry Ford Health System	Detroit	Michigan
United States	St. Bernards Research Center	Jonesboro	Arkansas
United States	University of Minnesota, Department of Medicine/Division of Infectious Diseases	Minneapolis	Minnesota
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
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	Triple O Research Institute, PA	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Italy,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an Adverse Event		Through and including 28 calendar days after the last administration of the investigational product	Yes
Secondary	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.	At End of Study visit	No

External Links

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