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

• Conditions: Influenza type A and B virus infection; MedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2006-006263-23-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-05
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? 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

Exclusion Criteria

? 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of treatment with Oseltamivir (Ro 64-0796) on viral shedding and on serum and cytoplasmatic inflammatory cytokine concentration.;Secondary Objective: ? To assess a correlation between serum and cytoplasmatic inflammatory cytokine and clinical picture and viral shedding ? To investigate the effect of treatment with Oseltamivir on patient?s health and functional status ? To define the circulation of viral strains resistant to antivirals ? To estimate the incidence of NI-resistant strains during treatment;Primary end point(s): The main endpoints are the times to return to normal health status and normal levels of activity