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Neuraminidase Inhibitor

oseltamivir (Tamiflu®) for Influenza

Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day to negative viral load for subjects positive at baseline
Awards & highlights

Summary

The purpose of this study is to learn how to treat influenza in children less than 2 years of age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age and older with influenza. Researchers want to learn more about the activity of Tamiflu® in the body to determine a dose of that is safe, well-tolerated, and effective in young children with influenza. Children less than 24 months of age with confirmed influenza will receive Tamiflu® 2 times a day for 5 days. Older participants will be enrolled first and younger children will be enrolled after the safety data is reviewed for older participants. Study procedures include blood samples, swabs from inside the nose, and body and nervous system evaluations. Participants may be involved in study related procedures for up to 37 days.

Eligible Conditions
  • Influenza

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study, from receipt of the first dose of study drug and continuing through study visit day 30 plus or minus 3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study, from receipt of the first dose of study drug and continuing through study visit day 30 plus or minus 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oseltamivir Carboxylate AUC12 (Area Under the Curve).
Secondary outcome measures
Correlation of Clearance of Viral RNA by Culture With Pharmacokinetic Parameters by Cohort
Correlation of Clearance of Viral RNA by Polymerase Chain Reaction (PCR) to Pharmacokinetic Parameters by Cohort.
Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)
+4 more

Side effects data

From 2010 Phase 1 & 2 trial • 87 Patients • NCT00391768
17%
Vomiting
17%
Otitis media
13%
Dermatitis diaper
8%
Upper respiratory tract infection
8%
Neutropenia
8%
Pyrexia
8%
Rash
8%
Erythema
4%
Rash macular
4%
Croup infectious
4%
Staring
4%
Teething
4%
Conjunctivitis bacterial
4%
Dehydration
4%
Nasopharyngitis
4%
Diarrhoea
4%
Lethargy
4%
Flatulence
4%
Cough
4%
Urine odour abnormal
4%
Influenza
4%
Urinary tract infection
4%
Wheezing
4%
Dyspnoea
4%
Conjunctivitis
4%
Constipation
4%
Roseola
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort III
Cohort IB
Cohort IIA
Cohort IIB
Cohort IV
Cohort V
Cohort IA

Trial Design

1Treatment groups
Experimental Treatment
Group I: oseltamivir (Tamiflu®)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oseltamivir
FDA approved

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,302 Previous Clinical Trials
5,501,355 Total Patients Enrolled
~5 spots leftby Sep 2025