An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu®) in the treatment of infants 0 to <12 months of age with confirmed influenza infectio

• Conditions: Treatment of influenza; MedDRA version: 12.0Level: LLTClassification code 10022000Term: Influenza

• Registration Number: EUCTR2009-014365-12-FR
• Lead Sponsor: F.Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-15
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Post natal age:
• Cohort I: 3 to < 12 months
• Cohort II: 1 to < 3 months
• Cohort III: 0 to 30 days
2. Confirmed laboratory diagnosis of influenza by PCR or rapid influenza diagnostic test within 96 hours prior to first dose
3. Duration of influenza symptoms = 96 hours prior to first dose

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Post conceptual age less than 36 weeks
- Weight less than 5th percentile for age (corrected for gestation)
- concurrent gastrointestinal conditions that preclude enteric absorption of the drug
- bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrolment
- Have evidence of active or uncontrolled respiratory, cardiac, hepatic, CNS or renal
disease unrelated to influenza at baseline
- Non-study treatment with Oseltamivir for the current illness prior to first study
dose

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to define the pharmacokinetics of oseltamivir and oseltamivir<br>carboxylate in children with confirmed influenza up to one year of age.;Secondary Objective: The secondary objectives are:<br>• to describe the frequency of all adverse events among treated children<br>• to assess the clearance of virus and viral RNA<br>• to determine the potential for the development of resistance to oseltamivir<br>• to explore other pharmacodynamic parameters (e.g. resolution of fever);Primary end point(s): The primary variables are the steady-state pharmacokinetic parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate.