A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IIIb, Open-label, Comparative, Randomized Study on Resistance of Influenza A/H1N1 2009 Virus to Treatment With Oseltamivir at Standard Dose Versus Double Dose

Conditions
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Influenza

Intervention / Treatment
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* Drug: Oseltamivir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: positive rapid antigen test for influenza A onset of symptoms of influenza (fever, at least one respiratory symptom) </=48 hours Exclusion Criteria: clinical suspicion of infection with a respiratory virus other than influenza suspicion of invasive bacterial infection evidence of poorly controlled underlying disease known immunosuppression known allergy to Oseltamivir women who are pregnant or planning to get pregnant during the study

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Dose<br>Oseltamivir capsule will be administered orally at a dose of 75 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days. | Drug: Oseltamivir<br>* Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days<br>* Other names: Tamiflu;|
| Active Comparator: Double Dose<br>Oseltamivir capsule will be administered orally at a dose of 150 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days. | Drug: Oseltamivir<br>* Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days<br>* Other names: Tamiflu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Excreting Resistant Virus | Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1). | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Day 5 |