Clinical trial NCT01032837: A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain
Official title: A Randomized, Multicenter Trial of Oseltamivir [Tamiflu] Doses of 75 mg for 5 or 10 Days Versus 150 mg for 5 or 10 Days to Evaluate the Effect on the Duration of Viral Shedding in Influenza Patients With Pandemic (H1N1) 2009
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 102
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Pediatric, adolescent and adult patients \>/=1 year of age
* Fever \>/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)
* Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug
* \</=96 hours between onset of influenza-like illness and first dose of oseltamivir

Exclusion Criteria:

* Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration
* History of chronic renal failure or clinical suspicion of renal failure at baseline
* Clinical evidence of hepatic compensation at the time of randomization
* Known HIV infection
* Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication

Primary outcomes:
measure: Time to Cessation of Viral Shedding
timeFrame: Day 1 to Day 40
Secondary outcomes:
measure: Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture
timeFrame: Baseline and Days 3, 6, 8, 11, 15 and 40
measure: Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction
timeFrame: Baseline and Days 3, 6, 8, 11, 15 and 40
measure: Change From Baseline in Influenza Titer Measured by Viral Culture
timeFrame: Baseline, Days 2 through 15
measure: Number of Participants With Development of Oseltamivir-Resistant Influenza Virus
timeFrame: 40 days
measure: Time to Resolution of Fever
timeFrame: Day 1 through Day 40
measure: Time to Alleviation of All Clinical Symptoms - Children
timeFrame: Day 1 to Day 40
measure: Time to Alleviation of All Clinical Symptoms - Adults
timeFrame: Day 1 to Day 40
measure: Number of Participants Who Developed Secondary Illnesses During the Study
timeFrame: Day 1 through Day 40
measure: Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics
timeFrame: Day 1 through Day 40
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Carmichael
country: United States
state: California
city: Downey
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Lomita
country: United States
state: California
city: National City
country: United States
state: California
city: Paramount
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Deland
country: United States
state: Florida
city: Fleming Island
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: St. Cloud
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Dubuque
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Madisonville
country: United States
state: Kentucky
city: Lake Charles
country: United States
state: Louisiana
city: Mandeville
country: United States
state: Louisiana
city: Meltairie
country: United States
state: Louisiana
city: Shreveprt
country: United States
state: Louisiana
city: Brockton
country: United States
state: Massachusetts
city: Stevensville
country: United States
state: Michigan
city: Bridgeton
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Bozeman
country: United States
state: Montana
city: Bellevue
country: United States
state: Nebraska
city: Freemont
country: United States
state: Nebraska
city: Haddon Heights
country: United States
state: New Jersey
city: Sicklerville
country: United States
state: New Jersey
city: Camillus
country: United States
state: New York
city: Endwell
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: Asheboro
country: United States
state: North Carolina
city: Burlington
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Harrisburg
country: United States
state: North Carolina
city: Mooresville
country: United States
state: North Carolina
city: Morganton
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Canal Fulton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Ashland
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Collegeville
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Jefferson Hills
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Scotland
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Bedford
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: New Braunfels
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Clinton
country: United States
state: Utah
city: Magna
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Saratoga Springs
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Vienna
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: