EUCTR2006-003284-31-DE进行中（未招募）不适用
An open label multi-center trial of oseltamivir for the seasonal prophylaxis of influenza in children
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
- 50
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
- •Males or females 1 to 12 years of age; females must be pre-menarchal
- •Subject is a candidate for seasonal prophylaxis in the opinion of the Principal
- •investigator
- •Negative rapid diagnostic test for influenza at baseline
- •Parent/guardian willing and able to comply with study requirements and give consent
- •Subject able to comply with study requirements and willing to give assent, as
- •appropriate
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Symptoms suggestive of influenza-like illness, including but not limited to, fever,
- •cough, or nasal congestion
- •Positive rapid diagnostic test for influenza
- •Creatinine clearance < 30 ml/min/1.73M2
- •Females of child-bearing potential
- •Uncontrolled renal, vascular, neurologic, metabolic, or pulmonary disease or known chronic renal failure, hepatitis or cirrhosis. Uncontrolled is defined as disease requiring change of therapy or hospitalization within 4 weeks preceding the first dose of study medication. Change of therapy is defined as dose increase or change of medication.
- •Allergy to the test medication
- •Hereditary fructose intolerance (for subjects who will be taking the liquid formulation)
- •Malignancy at the time of enrollment excluding adequately treated skin carcinoma (basal or squamous cell)
- •Participation in a clinical trial with an investigational drug in the 4 weeks prior to
- •enrollment. Patients enrolled in this study can not be enrolled in another study
- •for either research, diagnostic or treatment purposes.
- •Antiviral treatment (example: amantadine, rimantadine, zanamavir, oseltamivir
- •and ribavirin) for influenza in the 2 weeks prior to enrollment.
- •Use of live influenza vaccine (example FluMist) in the 2 weeks prior to enrollment.
研究者
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