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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: oseltamivir [Tamiflu] (Drug); oseltamivir [Tamiflu] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

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 100.

Clinical Details

Official title: An Unblinded, Comparative, Randomized Study of Influenza A/H1N1 2009 Resistance in Patients With Standard and Double Dose Oseltamivir Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy of double versus standard dose on frequency of isolation of resistant virus

Secondary outcome:

Efficacy of double versus standard dose on reduction in viral load

Presence or absence of clinical signs and symptoms in patients shedding resistant virus at day 5

Eligibility

Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.

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) 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

Locations and Contacts

Curitiba 80810-040, Brazil

Sao Paulo 04025-002, Brazil

Sao Paulo 05508-000, Brazil

Additional Information

Starting date: July 2009
Last updated: August 17, 2015

Page last updated: August 23, 2015

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