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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Optic Nerve Diseases

Intervention: Zyvox - linezolid (Drug); Matched control (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

Primary outcome: Percentage of Participants With an Adverse Event

Secondary outcome: Percentage of Participants by Clinical Outcome of Infection at End of Study

Detailed description: Characterize Optic Side Effect

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Azienda Ospedaliera Universitaria di San Martino, Genova 16132, Italy

Ospedale San Martino, Clinica Malattie Infettive, Genova 16132, Italy

Università di Genova, Genova 16132, Italy

Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine 33100, Italy

Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge, Stockholm 141 86, Sweden

St. Bernards Research Center, Jonesboro, Arkansas 72401, United States

Triple O Research Institute, PA, West Palm Beach, Florida 33401, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

University of Minnesota, Department of Medicine/Division of Infectious Diseases, Minneapolis, Minnesota 55455, United States

Drexel University College of Medicine, Partnership Comprehensive Care Practice, Philadelphia, Pennsylvania 19102, United States

Associates in Infectious Disease and Tropical Medicine, Pittsburgh, Pennsylvania 15206, United States

Additional Information

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

Starting date: November 2008
Last updated: June 3, 2015

Page last updated: August 23, 2015

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