PROSPECTIVE STUDY OF OPHTHALMOLOGIC FUNCTION IN PATIENTS RECEIVING LINEZOLID FOR TWO MONTHS OR GREATER - N/A

• Conditions: This study is designed to understand the effects of linezolid on the optic nerve by observing and following patients who have been treated with linezolid for two months or longer for the development of signs or symptoms of visual disturbance or eye disorders.; MedDRA version: 14.1Level: PTClassification code 10061323Term: Optic neuropathySystem Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2006-002303-14-SE
• Lead Sponsor: Pfizer Inc. 235 East 42nd Street, New York, NY10017, USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-27
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria for Subjects in Treated Group

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
study:

1. Male and female, in- or out-patient subjects who are 18 years of age or older;

2. Subjects must have received linezolid 600 mg BID for two months or greater (ie, at
least 60 days) and be currently on drug (or have received linezolid for two months or
greater and have discontinued use within 7 days of baseline evaluation);

3. Subjects who have current signs or symptoms compatible with linezolid toxicity (ie,
optic or peripheral neuropathy) may be enrolled regardless of whether treatment will
be continued. The decision to continue linezolid treatment in the presence of signs of
optic or peripheral neuropathy will be at the discretion of the treating physician based
on his/her assessment weighing the continued risk of progression of these findings
against the medical need for continued treatment with linezolid;

4. Subjects must give informed consent by signing and dating an informed consent form
prior to study entry;

5. Subjects must be willing to complete all study-related activities and follow-up visits
required by the protocol;

6. Women of childbearing potential must use adequate contraception, defined as
hormonal contraception, intrauterine device, or barrier methods (condoms or vaginal
diaphragm) with spermicide, throughout the study. Within 24 hours prior to study
entry, the pregnancy test (urine or serum gonadotropin) must be negative. Women
who have been surgically sterilized or are at least two years postmenopausal may be
enrolled and do not have to use birth control.

Inclusion Criteria for Subjects in Control Group

Control subjects will be matched to each linezolid subject based on the following:
• Age – control subjects should be within approximately 5 years of age of treated
subjects;
• Gender;
• Type of Infection – infection for which long-term antibiotic treatment is indicated
(eg, chronic bone and joint infections, unresectable infected grafts or devices or
chronic infections in immunocompromised hosts);
• Currently on an antibiotic treatment for 2 months or greater.
If possible the following will be matched:
• Co-morbidities (eg, HIV, cancer, renal failure, diabetes, etc);
• Center/institution and inpatient/outpatient status.
If there are questions regarding the control subjects matched inclusion criteria, the sponsor
should be consulted.

1. Male and female, in- or out-patient subjects who are 18 years of age or older.

2. Currently on antibiotic treatment for 2 months or greater (ie, at least 60 days).

3. Subjects must give informed consent by signing and dating an informed consent form
prior to study entry.

4. Subjects must be willing to complete all study-related activities required by the
protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria for Subjects in Treated Group

Subjects presenting with any of the following will not be included in the study:

1. Subjects of childbearing potential who are unable to take adequate contraceptive
precautions, have a positive pregnancy test result within 24 hours prior to study entry,
are otherwise known to be pregnant, or are currently breastfeeding an infant;

2. Subjects with a known presence of optic nerve damage due to another illness,
condition or medication other than linezolid;

3. Subjects with a known presence of peripheral nerve damage due to another illness or
medication other than linezolid. Those with mild diabetic neuropathy (ie a modified
Nerve Test Score of =2) may be included.

4. Subjects with a pre-existing or a diagnosis at the screening visit of an ophthalmologic
condition that would adversely affect the study testing protocol (eg, dense cataracts,
macular degeneration, congenital color vision deficiency, nystagmus, high myopia,
retinitis pigmentosa);

5. 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;

6. Subjects who are currently receiving or anticipated to receive another medication,
antibiotic or other, that has a strong potential to produce optic nerve toxicity (eg,
ethambutol) or peripheral nerve toxicity, (eg, metronidazole and isoniazid).

7. Subjects with deficiency states, particularly of thiamine, vitamin B12, folate, induced
either by starvation, malabsorption, or alcoholism which may cause optic neuropathy;

8. Subjects with evidence of lactic acidosis or have a condition (eg, mitochondrial
enzyme defects, hepatic failure, and/or metastatic cancer) or on a medication that
causes it (eg, nucleoside analogues).

9. Subjects with an active communicable disease (ie, tuberculosis assessed as currently
communicable);

10. Subjects with a mental condition or use of alcohol and/or other drugs that would
result in his/her inability to participate in the trial and all study visits in the judgment
of the investigator;

11. Subjects who have severe liver disease (Child-Pugh Class C hepatic insufficiency), or
subject with SGPT and/or SGOT >5 X ULN (upper limit of normal);

12. Subjects with any other condition, which, in the investigator’s judgment might
decrease the chance of obtaining satisfactory data to achieve the objectives of the
study.

Exclusion Criteria for Subjects in Control Group

1. Subjects must not currently be taking linezolid or have received it for more than
7 days at any time.

2. Subjects with a known presence of optic nerve damage due to another illness,
condition or medication.

3. Subjects with a known presence of peripheral nerve damage due to another illness.
Those with mild diabetic neuropathy (ie, a modified Nerve Test Score of =2) may be
included.

4. Subjects with a pre-existing or a diagnosis at the screening visit of an ophthalmologic
condition that would adversely affect the study testing protocol (eg, dense cataracts,
macular degeneration, congenital color vision deficiency, nystagmus, high myopia,
retinitis pigmentosa).

5. 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.

6. Subjects who a

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified