EUCTR2010-020083-38-HU进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 118
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 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
- •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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