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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
St. Bernards Research Center
Jonesboro, Arkansas, 72401 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Optic Nerve Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00359632
Pfizer
Terminated
Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater

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Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater
Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Six Weeks Or Greater
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.
Characterize Optic Side Effect
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Optic Nerve Diseases
  • 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.
  • Drug: 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.
  • Experimental: 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.
    Intervention: Drug: Zyvox - linezolid
  • Active Comparator: 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.
    Intervention: Drug: Matched control
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Sweden,   United States
 
 
NCT00359632
A5951110
2006-002303-14 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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