Clinical trial NCT01050257: A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
Official title: A Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater Than or Equal to 13 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-15
Enrollment: 118
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.


Eligibility criteria: Inclusion Criteria:

* Adult and adolescent patients, 13 years of age and older
* Diagnosis of influenza
* ≤ 144 hours between the onset of influenza-like illness and first dose of study drug

Non-randomized, open-label treatment group:

* Patients with moderate/severe renal impairment or renal failure with creatinine clearance 10-60 mL/min

Exclusion Criteria:

* Clinical evidence of severe hepatic decompensation at the time of randomization
* Acute ischemia or significant arrhythmia

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death
timeFrame: Up to 30 days
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Days 1, 3
measure: Percentage of Participants With Viral Shedding by Culture or RT-PCR
timeFrame: Days 1, 4, 6, 11, 15 and 30
measure: Percentage of Participants With Viral Shedding by Culture
timeFrame: Days 1, 4, 6, 11, 15, 30
measure: Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
timeFrame: Days 1, 4, 6, 11, 15 and 30
measure: Change From Baseline in Influenza Titer by Culture at Day 4
timeFrame: Baseline, Day 4
measure: Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4
timeFrame: Baseline, Day 4
measure: Percentage of Participants Who Had a Fever During the Study
timeFrame: Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108
measure: Time to Resolution of Fever for Participants Who Had a Fever at Baseline
timeFrame: Baseline, Up to 30 Days
measure: Number of Participants With Viral Resistance
timeFrame: 30 days
measure: Percentage of Participants With Influenza Symptoms
timeFrame: Days 1, 11, 15, 30
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Duarte
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Wilmington
country: United States
state: Delaware
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Overland Park
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Madisonville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: St. Joseph
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Grand Island
country: United States
state: Nebraska
city: Holmdel
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: South Bronx
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Charleston
country: United States
state: West Virginia
city: Odense C
country: Denmark
city: Bron
country: France
city: Garches
country: France
city: La Tronche
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Tours
country: France
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Miskolc
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Veszprem
country: Hungary
city: Genova
country: Italy
city: Milano
country: Italy
city: Monza
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Bialystok
country: Poland
city: Chorzow
country: Poland
city: Radom
country: Poland
city: Warszawa
country: Poland
city: Bucharest
country: Romania
city: Constanta
country: Romania
city: Craiova
country: Romania
city: Timisoara
country: Romania
city: Elche
country: Spain
state: Alicante
city: Almeria
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: