Efficacy of Oseltamivir treatment in laboratory- confirmed influenza: evaluation of effect on viral shedding and on serum and cytoplasmatic inflammatory cytokine concentration.

ROCHE0 个研究点开始时间: 2012年1月5日最近更新: 2014年1月27日

适应症

试验速览

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•? Ambulatory male and female patients ? Adults subjects between 18 to 64 years of age inclusive ? Able to participate and willing to give written informed consent ? Influenza -like illness (ILI) defined as follows: Sudden onset of the following symptoms: - fever >38°C AND - at least one of respiratory symptoms (i.e. cough, sore throat, coryza, etc.) AND - at least one systemic symptom (i.e. myalgia, fatigue , headhache , chills/sweat) ? positive rapid assay for detection of influenza antigen
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•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

•? Presentation later than 36 hours after the onset of symptoms.
•? Presenting with influenza-like symptoms outside an outbreak based on local surveillance activities.
•? Women who are lactating or pregnant.
•? Patients with uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis or cirrhosis. For the purposes of this study uncontrolled is defined as disease requiring a change of drug therapy (including an increase in dose), or hospitalisation within four weeks prior to study day 1. In patient hospitalisation of less than 24 hours duration will be permitted.
•? Transplant patients or patients known to have HIV infection.
•? Patients who have received an investigational new drug within the 30 days prior to study day 1.
•? Influenza vaccination within November 2006 to January 2007
•? Allergy to oseltamivir or any excipients in the capsules of study medication (see protocol section 8.1)
•? Receipt of antiviral therapy (such as amantadine, rimantadine, zanamivir, ribavirin, interferon) or systemic steroids or immuno-suppressants within two weeks prior to study day 1.
•? A clinically relevant history of abuse of alcohol or other drugs

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