EUCTR2006-002303-14-IT进行中（未招募）不适用
PROSPECTIVE STUDY OF OPHTHALMOLOGIC FUNCTION IN PATIENTS RECEIVING LINEZOLID FOR TWO MONTHS OR GREATER - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER
- 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
- •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);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.
- •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
- •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). A list of medications known to be associated with optic and/or peripheral neuropathies is provided in Appendix 2; 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). A list of medications known to be associated with lactic acidosis is provided in Appendix 3; 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.
研究者
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