EUCTR2010-020083-38-PL进行中（未招募）不适用
A Multicenter, Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged =13 Years
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Male and female adults and adolescents, 13 years of age and older, except in Germany and Denmark, where the subjects enrolled should be 18 years of age or older.
- •In France, patients enrolled into the renal impairment arm must be 18 years of age or older.
- •Diagnosis of influenza (in Spain, Denmark and Germany: severe influenza requiring hospitalization) by virology testing or clinical diagnosis based on symptoms suggestive of influenza
- •In Spain, Denmark and Germany: Hospitalized patients or requiring hospitalization and/or who are medically evaluated to not be good candidates for oral treatment and/or who might benefit from the IV administration of oseltamivir.
- •Less than or equal to 144 hours between the onset of influenza-like illness and first dose of study medication
- •Patient is willing and able to comply with study requirements and give consent, or, if applicable, consent may be given by a parent, legal guardian or legal representative
- •Except in Spain, Denmark, and Germany: Patients who are pregnant may be enrolled only if the potential benefit justifies the potential risk to the fetus
- •Except in Spain and Denmark: Patients who are lactating may be enrolled only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant. In Germany, patients who are
- •lactating must also be unable to receive oral oseltamivir.
- •In Spain and Denmark: Subjects who are in the reproductive age group and sexually active must agree to utilize and an effective method of contraception throughout the study period and for one reproductive cycle following cessation of the study therapy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 11
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 149
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Patients with clinical evidence of severe hepatic decompensation at the time of randomization (e.g., evidence of jaundice, ascites, hepatic encephalopathy, and coagulation disturbances-Child-Pugh score above 9).
- •Electrocardiogram showing acute ischemia or significant arrhythmia
- •Allergy to test medication
- •Patients taking probenicid medication within 7 days before starting study medication
- •Participation in a clinical trial or expanded access trial with an investigational drug in the 4 weeks prior to randomization (for renally impaired patients: 4 weeks prior to first dose of study medication).
- •In Germany: Pregnant women
- •In Spain and Denmark: Pregnant and lactating women
研究者
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