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

NCT00359632 | Terminated Phase 3 Results

• 2 other identifiers: A59511102006-002303-14
• Study Type: interventional
• Target: 34
• Locations: 3 countries
• Sites: 12

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.

Conditions

Optic Nerve Diseases

Keywords

Optic neuropathy following long-term linezolid use

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Adverse Event

  Through and including 28 calendar days after the last administration of the investigational product

Secondary Outcomes (1)

• Percentage of Participants by Clinical Outcome of Infection at End of Study

  At End of Study visit

Study Arms (2)

Linezolid

EXPERIMENTAL

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.

Drug: Zyvox - linezolid

Matched control

ACTIVE COMPARATOR

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.

Drug: Matched control

Interventions

Zyvox - linezolid DRUG

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.

Linezolid

Matched control DRUG

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.

Matched control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

St. Bernards Research Center

Jonesboro, Arkansas, 72401, United States

Location

Triple O Research Institute, PA

West Palm Beach, Florida, 33401, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota, Department of Medicine/Division of Infectious Diseases

Minneapolis, Minnesota, 55455, United States

Location

Drexel University College of Medicine, Partnership Comprehensive Care Practice

Philadelphia, Pennsylvania, 19102, United States

Location

Associates in Infectious Disease and Tropical Medicine

Pittsburgh, Pennsylvania, 15206, United States

Location

Azienda Ospedaliera Universitaria di San Martino

Genova, 16132, Italy

Location

Ospedale San Martino, Clinica Malattie Infettive

Genova, 16132, Italy

Location

Università di Genova

Genova, 16132, Italy

Location

Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia

Udine, 33100, Italy

Location

Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge

Stockholm, 141 86, Sweden

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Optic Nerve Diseases

Interventions

Case-Control Studies

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

This pilot study was exploratory and not designed to be powered for safety or efficacy. Controls were not followed post-baseline whereas linezolid patients returned for multiple study visits. The study was terminated early due to slow enrollment.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 2, 2006
• Study Start: November 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 26, 2015
• Results First Posted: June 26, 2015

Record last verified: 2015-06

Locations

SE (1); IT (4); US (7)