NCT00949533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2009

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

August 8, 2016

Completed
Last Updated

August 8, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

July 15, 2009

Results QC Date

April 29, 2016

Last Update Submit

June 27, 2016

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Excreting Resistant Virus

    Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).

    Day 5

Secondary Outcomes (3)

  • Percentage of Participants With A Reduction in Viral Load

    Baseline, Day 5

  • Number of Participants With Various Clinical Signs and Symptoms

    Day 5

  • Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected

    Day 5

Study Arms (2)

Standard Dose

EXPERIMENTAL

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.

Drug: Oseltamivir

Double Dose

ACTIVE COMPARATOR

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.

Drug: Oseltamivir

Interventions

OseltamivirDRUG

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

Also known as: Tamiflu
Double DoseStandard Dose

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • positive rapid antigen test for influenza A
  • onset of symptoms of influenza (fever, at least one respiratory symptom) \</=48 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Curitiba, 80810-040, Brazil

Location

Unknown Facility

São Paulo, 04025-002, Brazil

Location

Unknown Facility

São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 30, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 8, 2016

Results First Posted

August 8, 2016

Record last verified: 2016-06

Locations

BR(3)