Influenza type A and B virus infection MedDRA version: 14.1 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: TAMIFLU
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Oseltamivir
Concentration unit: mg milligram(s)
Concentration number: 75-
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed