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

Phase 3

Terminated

• Conditions: Optic Nerve Diseases
• Interventions: Drug: Zyvox - linezolid; Drug: Matched control

• Registration Number: NCT00359632
• Lead Sponsor: Pfizer

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-07-28
• Study First Submitted QC: 2006-07-28
• Study First Posted: 2006-08-02
• Study Start: 2008-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-12-16
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-03
• Last Update Submitted: 2015-06-03
• Results First Posted: 2015-06-26
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linezolid	Zyvox - linezolid	Subjects have received at least 6 weeks of linezolid therapy (600 mg BID). Continued duration of linezolid treatment is based on treating physician's benefit/risk assessment. A matching control who did not receive linezolid will be selected for each linezolid treated subject.
Matched control	Matched control	Control subjects individually matched to linezolid subjects (on age, gender and type of infection) who received at least 6 weeks of antibiotics other than linezolid. Control group assessed only at baseline visit to assess presence of background abnormalities in the study test panel.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Adverse Event	Through and including 28 calendar days after the last administration of the investigational product

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants by Clinical Outcome of Infection at End of Study	At End of Study visit	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.

Trial Locations

Locations (12)

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Triple O Research Institute, PA; 🇺🇸 West Palm Beach, Florida, United States

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

Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia; 🇮🇹 Udine, Italy

Azienda Ospedaliera Universitaria di San Martino; 🇮🇹 Genova, Italy

St. Bernards Research Center; 🇺🇸 Jonesboro, Arkansas, United States

Ospedale San Martino, Clinica Malattie Infettive; 🇮🇹 Genova, Italy

Università di Genova; 🇮🇹 Genova, Italy

Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge; 🇸🇪 Stockholm, Sweden