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

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-28
• Study Completion: 2014-06-04
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 65

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