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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
Oseltamivir capsules for participants ≥ 13 years.
Pediatric suspension for participants aged ≤ 12 years.
Matching placebo provided as capsules and as a suspension.
Time to Cessation of Viral Shedding
The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.
Time frame: Day 1 to Day 40
Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture
Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory.
Time frame: Baseline and Days 3, 6, 8, 11, 15 and 40
Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction
Viral shedding was measured by reverse transcriptase polymerase chain reaction (RT-PCR) from samples obtained from nasal and throat swabs and performed by the central laboratory.
Time frame: Baseline and Days 3, 6, 8, 11, 15 and 40
Change From Baseline in Influenza Titer Measured by Viral Culture
Influenza virus titer measured by viral culture and expressed on a Log10 scale of the 50% Tissue Culture Infective Dose (TCID50; amount of virus required to kill 50% of inoculated tissue culture cells).
Time frame: Baseline, Days 2 through 15
Number of Participants With Development of Oseltamivir-Resistant Influenza Virus
The last positive viral isolate from each patient was tested for reduced sensitivity to oseltamivir. Phenotypic assay was performed to determine the susceptibility of the last positive viral isolate from each patient. If required, a genotypic assay to determine the contribution of both the neuraminidase (NA) and hemagglutinin (HA) genes to decreased susceptibility was also performed.
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Unnamed facility
Tuscaloosa, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Jonesboro, Arkansas, United States
Unnamed facility
Carmichael, California, United States
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Downey, California, United States
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Fountain Valley, California, United States
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Huntington Beach, California, United States
Unnamed facility
Lomita, California, United States
...and 90 more locations
Time frame: 40 days
Time to Resolution of Fever
Temperature was recorded by the patient in a diary twice daily for 10 days and once daily thereafter. Fever was defined as a body temperature greater than or including 37.8 degrees Celsius (or ≥ 100.04 Fahrenheit). Time to resolution of fever was defined as the total number of hours from the first dose of study medication to the first time at which temperature is ≤ 37.2 degrees Celsius and lasts at least 21.5 hours. Patients who were still febrile at the end of the study period were censored at that time.
Time frame: Day 1 through Day 40
Time to Alleviation of All Clinical Symptoms - Children
Daily influenza-like symptoms (such as poor appetite, irritability, low energy, nasal congestion, runny nose etc) were recorded in a diary on a scale from 0 (no problem) to 3 (major problem). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'no problem' or 'minor problem' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.
Time frame: Day 1 to Day 40
Time to Alleviation of All Clinical Symptoms - Adults
Daily influenza-like symptoms (such as nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills) were recorded in a diary on a scale from 0 (absent) to 3 (severe). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'absent' or 'mild' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.
Time frame: Day 1 to Day 40
Number of Participants Who Developed Secondary Illnesses During the Study
The number of participants who developed secondary illnesses due to influenza, including four pre-defined adverse events: otitis media, bronchitis, pneumonia, or sinusitis at any time during the study.
Time frame: Day 1 through Day 40
Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics
The number of participants who developed secondary illnesses due to influenza, including otitis media, bronchitis, pneumonia, or sinusitis at any time during the study which were treated with antibiotics.
Time frame: Day 1 through Day 40