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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Drug: Oseltamivir

• Registration Number: NCT00949533
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Study Start: 2009-08
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2016-04-29
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Results First Posted: 2016-08-08
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dose	Oseltamivir	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.
Double Dose	Oseltamivir	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Excreting Resistant Virus	Day 5	Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Various Clinical Signs and Symptoms	Day 5	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.
Percentage of Participants With A Reduction in Viral Load	Baseline, Day 5	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.
Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected	Day 5	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.