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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949533
• Other study ID #: ML22789
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2009
• Last updated: February 1, 2016
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: CONEP - Commissão Nacional de Ética em Pesquisa
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• oseltamivir [Tamiflu]
standard dose (30 - 75 mg orally bid) for 5 days
• oseltamivir [Tamiflu]
double dose (60 - 150 mg orally bid) for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of double versus standard dose on frequency of isolation of resistant virus		assessed day 5 of treatment	No
Secondary	Efficacy of double versus standard dose on reduction in viral load		assessed day 5 of treatment	No
Secondary	Presence or absence of clinical signs and symptoms in patients shedding resistant virus at day 5		assessed day 5 of treatment	No