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

Roche

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Drug: Oseltamivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949533

ML22789

Details and patient eligibility

About

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 (</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams [mg] orally twice daily [bid]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (>) 100.

Enrollment: 37 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Standard Dose

Experimental group

Description:

Oseltamivir capsule will be administered orally at a dose of 75 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter \[mg/mL\]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.

Treatment:

Drug: Oseltamivir

Double Dose

Active Comparator group

Description:

Oseltamivir capsule will be administered orally at a dose of 150 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.

Treatment:

Drug: Oseltamivir