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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00949533
First received: July 15, 2009
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Influenza
Drug: Oseltamivir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Excreting Resistant Virus [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    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.


Enrollment: 37
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard Dose
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
Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days
Other Name: Tamiflu
Active Comparator: Double Dose
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
Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days
Other Name: Tamiflu

  Eligibility

Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949533

Locations
Brazil
Curitiba, Brazil, 80810-040
Sao Paulo, Brazil, 04025-002
Sao Paulo, Brazil, 05508-000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00949533     History of Changes
Other Study ID Numbers: ML22789 
Study First Received: July 15, 2009
Results First Received: April 29, 2016
Last Updated: June 27, 2016
Health Authority: Brazil: CONEP - Commissão Nacional de Ética em Pesquisa

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016