Status: Recruiting

Official Title: An unblinded, comparative, randomized study of influenza A/H1N1 2009 resistance in patients with standard and double dose oseltamivir treatment

Brief 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 </=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.

Study Phase: 4

Study Type: Interventional; Prevention; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study

Condition: Influenza

Intervention Type: Drug

Intervention Name: oseltamivir [Tamiflu]

• 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

This trial will be conducted at the following locations:

• SAO PAULO 05508-000
• CURITIBA
• SAO PAULO