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

NCT ID: NCT00949533

Last Updated: 2016-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-10-31

Brief 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 (</=) 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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Dose

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.

Group Type: EXPERIMENTAL

Oseltamivir

Intervention Type: DRUG

Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days

Double Dose

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.

Group Type: ACTIVE_COMPARATOR

Oseltamivir

Intervention Type: DRUG

Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days

Interventions

Oseltamivir

Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days

Intervention Type: DRUG

Other Intervention Names

Tamiflu

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

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Curitiba, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

ML22789

Identifier Type: -

Identifier Source: org_study_id