Phase 3 N=37 Randomized Treatment

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

Influenza

Bottom Line

View on ClinicalTrials.gov: NCT00949533 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2016

Primary outcome: Primary: Percentage of Participants Excreting Resistant Virus — 26.3; 35.3 percentage of participants — p=0.825

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Oseltamivir (Drug)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Excreting Resistant Virus	26.3; 35.3	0.825
SECONDARY Percentage of Participants With A Reduction in Viral Load	100; 100	> 0.05
SECONDARY Number of Participants With Various Clinical Signs and Symptoms	10; 9; 10; 5; 2; 2	1.000
SECONDARY Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected	3; 4; 3; 3; 0; 1	—

Summary

This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to ( ) 100.

Eligibility Criteria

Inclusion Criteria

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
known allergy to Oseltamivir
women who are pregnant or planning to get pregnant during the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00949533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.