PER-052-00已完成未知
INEZOLID (PNU 100766) ADMINISTERED BY INTRAVENOUS AND ORAL VIA FOR THE TREATMENT OF COMPASSIVE USE IN PATIENTS WITH BACTERIAL INFECTIONS WITH SIGNIFICANT RESISTANCE
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 个研究点目标入组 0 人开始时间: 2000年9月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Microbiological: A significant infection (non-colonization) caused by a susceptible organism. There must be a pathogenic organism identified in the area of infection. Resistance or intermediate susceptibility of the organism to conventionally marketed antimicrobial agents, used to treat infections caused by said organism, clinical intolerance to them, or inability to tolerate long-term intravenous treatment.
- •Signs and Symptoms: Patients admitted to this program will demonstrate / have demonstrated, signs of a significant infectious disease, such as fever, chills with shivering, leukocytosis with prominent change to the left, or significant changes in vital signs.
- •Sex: Men and women are eligible to enter this study of the treatment program for compassionate use. Women of childbearing age should have a baseline pregnancy test, before taking linezolid, and practice an appropriate method for birth control, in order to avoid pregnancy while participating in this program. Since drug interaction studies with hormonal contraceptives were not conducted, the use of barrier or abstinence methods is recommended.
- •Age: Patients must be 5 years or older. It should be noted that only a few observations were made with linezolid in patients under 18 years of age. For more information, please see the Linezolid Researcher´s Booklet.
- •Clinical: Patients with pheochromocytoma, uncontrolled hyperthyroidism, or uncontrolled hypertension should consult the Medical Monitor of the Market Company for dosing.
- •Origin of the Infection: If the origin of the infection is a device or a prosthesis, it is expected to be removed.
排除标准
- •Pregnancy: Pregnancy is a relative contraindication since the safety of linezolid in the human fetus is unknown. The sponsor and regulatory agencies will have to agree to admit any pregnant patient.
- •Allergy: No patient will be admitted with sensitivity to oxazolidinones or to one of the excipients of any of the formulations
研究者
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