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2008年10月27日

概览

暂无简介。

注册库

who.int

开始日期

2008年10月27日

结束日期

待定

最后更新

11年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Pfizer Inc. 235 East 42nd Street, New York, NY10017, USA

•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

•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.