A study to assess the safety of Oseltamivir administered in the vein for the treatment of flu (Influenza) in patients of at least 13 years of age

INTERVENTION: Product Name: Oseltamivir Product Code: Ro 64‐0796/F09‐01 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Oseltamivir CAS Number: 204255‐11‐8 Current Sponsor code: Ro 64‐0796 Other descriptive name: OSELTAMIVIR PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Tamiflu Pharmaceutical Form: Capsule, hard INN or Proposed INN: Oseltamivir CAS Number: 204255‐11‐8 Current Sponsor code: RO0640796 Other descriptive name: OSELTAMIVIR PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Tamiflu Pharmaceutical Form: Capsule, hard INN or Proposed INN: Oseltamivir CAS Number: 204255‐11‐8 Other descriptive name: OSELTAMIVIR PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ CONDITION: Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] Treatment of Influenza [seasonal or pandemic (H1N1) 2009] ; MedDRA version: 14.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 10021881 ‐ Infections and infestations ; MedDRA version: 14.0 Level: LLT Classification code 10022003 Term: Influenza B virus infection System Organ Class: 10021881 ‐ Infections and infestations ; MedDRA version: 14.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 ‐ Infections and infestations ; MedDRA version: 14.0 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 10021881 ‐ Infections and infestations PRIMARY OUTCOME: Main Objective: To evaluate the safety of oseltamivir administered by intravenous infusion in the treatment of influenza [seasonal or pandemic (H1N1) 2009 influenza] Primary end point(s): The primary endpoints for safety will be assessments of adverse events, laboratory tests, vital signs and ECG measurements Secondary Objective: • To evaluate the pharmacokinetics of oseltamivir and oseltamivir carboxylate following IV administration of oseltamivir in patients with influenza; • To evaluate viral load and shedding; • To evaluate all isolates for phenotypic and, where necessary, genotypic resistance Timepoint(s) of evaluation of this end point: Adverse Events are evaluated throughout the study. Vital signs are evaluated at study visits Day 1, 6, 11, 15, 30 as well as at each IV dose. Laboratory tests are on Day 1, Day 3 or 4, within 24 hours of last IV dose and at Day 30. ECGs are before and after the 1st and 5th or 6th infusion as well as at Day 30. SECONDARY OUTCOME: Secondary end point(s): 1) Occurrence or non‐occurrence of shedding virus by culture; 2) Occurrence or non‐occurrence of shedding virus by RT‐PCR; 3) Viral load by culture ; 4) Body temperature; 5) Absence or presence of fever, where fever is defined as a body temperature = 37.8°C; 6) Absence or presence of symptoms of influenza—for example, nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills/sweats (feverish), vomiting, diarrhea Timepoint(s) of evaluation of this end point: 1) On Days 1, 4, 6, 11, 15 and 30; 2) On Days 1, 4, 6, 11, 15 and 30; 3) On Days 1, 4, 6, 11, 15, and 30; 4) Twice daily; 5) Twice daily; 6) On Days 1, 11, 15 and 30 ; ; ; INCLUSION CRITERIA: • 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 repres