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: August 4, 2014
Last verified: August 2014
  Purpose

This open-label randomized 2arm study will determine the emergence of viral resi stance in patients with seasonal influenza A infection treated with Tamiflu. Eli gible 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 d ays. 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
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, 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: August 4, 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 August 18, 2014