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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


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
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