Back to resultsA Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Oseltamivir
Sponsored by
About this trial
This is an interventional treatment trial for Influenza
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standard Dose
Double Dose
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Excreting Resistant Virus
Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00949533
Brief Title
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Double Dose
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Other Intervention Name(s)
Tamiflu
Intervention Description
Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days
Primary Outcome Measure Information:
Title
Percentage of Participants Excreting Resistant Virus
Description
Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Percentage of Participants With A Reduction in Viral Load
Description
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
Title
Number of Participants With Various Clinical Signs and Symptoms
Description
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
Title
Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Curitiba
ZIP/Postal Code
80810-040
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04025-002
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05508-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
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