A Study on Emergence of Resistance With Tamiflu (Oseltamivir) in Patients 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: April 1, 2014
Last verified: April 2014
  Purpose

This open-label randomized 2arm study will determine the emergence of viral resistance in patients with seasonal influenza A infection treated with Tamiflu. Eligible patients </=5 years of age will be randomized to receive Tamiflu at either standard dose (30-75mg orally bid) or double dose (60-150mg orally bid) for 5 days. Target sample size is >100.


Condition Intervention Phase
Influenza
Drug: oseltamivir [Tamiflu]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Unblinded, Comparative, Randomized Study of Influenza A/H1N1 2009 Resistance in Patients With Standard and Double Dose Oseltamivir Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy of double versus standard dose on frequency of isolation of resistant virus [ Time Frame: assessed day 5 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of double versus standard dose on reduction in viral load [ Time Frame: assessed day 5 of treatment ] [ Designated as safety issue: No ]
  • Presence or absence of clinical signs and symptoms in patients shedding resistant virus at day 5 [ Time Frame: assessed day 5 of treatment ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: oseltamivir [Tamiflu]
standard dose (30 - 75 mg orally bid) for 5 days
Active Comparator: 2 Drug: oseltamivir [Tamiflu]
double dose (60 - 150 mg orally bid) for 5 days

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female patients >/= 5 years of age
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949533

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00949533     History of Changes
Other Study ID Numbers: ML22789
Study First Received: July 15, 2009
Last Updated: April 1, 2014
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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014