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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00359632
• Date of registration: 28/07/2006
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater
• Scientific title: Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Six Weeks Or Greater
• Date of first enrolment: November 2008
• Target sample size: 34
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00359632
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Italy, Sweden, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Optic Nerve Diseases

Intervention(s)

Drug: Matched control

Drug: Zyvox - linezolid

Primary Outcome(s)

Percentage of Participants With an Adverse Event [Time Frame: Through and including 28 calendar days after the last administration of the investigational product]

Secondary Outcome(s)

Percentage of Participants by Clinical Outcome of Infection at End of Study [Time Frame: At End of Study visit]

Secondary ID(s)

2006-002303-14

A5951110

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/06/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00359632