This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (\</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams \[mg\] orally twice daily \[bid\]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (\>) 100.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days
Unnamed facility
Curitiba, Brazil
Unnamed facility
São Paulo, Brazil
Unnamed facility
São Paulo, Brazil
Percentage of Participants Excreting Resistant Virus
Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).
Time frame: Day 5
Percentage of Participants With A Reduction in Viral Load
Viral load is defined as the amount of H1N1 virus in blood. As per investigator, a participant was considered as having viral load reduction at Day 5 if the Day 5 viral load was lower than the Baseline viral load.
Time frame: Baseline, Day 5
Number of Participants With Various Clinical Signs and Symptoms
Number of participants with various clinical signs and symptoms, as per investigator's discretion, were reported. Same participants were reported in more than 1 category. "Other" in the category included abdominal pain, breathlessness, thoracic pain and tired.
Time frame: Day 5
Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected
Number of participants with various clinical signs and symptoms, as per investigator's discretion, in whom new AH1N1 virus was detected, were reported. Same participants were reported in more than 1 category.
Time frame: Day 5
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