EUCTR2006-002303-14-SE进行中（未招募）不适用
PROSPECTIVE STUDY OF OPHTHALMOLOGIC FUNCTION IN PATIENTS RECEIVING LINEZOLID FOR TWO MONTHS OR GREATER - N/A
Pfizer Inc. 235 East 42nd Street, New York, NY10017, USA0 个研究点目标入组 60 人开始时间: 2008年10月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria for Subjects in Treated Group
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
- •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
- •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
- •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
排除标准
- •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
- •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
- •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
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