A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza

Phase 1

Conditions: Influenza
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2016-003003-54-Outside-EU/EEA

Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 36

Inclusion Criteria

Infant patients
Date of birth to date of enrollment is <1 year
Diagnosis of influenza
Duration of influenza symptoms Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days (5 or 6 doses of study drug)
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
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

Date of conception to date of birth + date of birth to enrollment is <36 weeks
Creatinine clearance <30 mL/min/1.73m2
Patients receiving any form of renal replacement therapy at baseline
Clinical evidence of severe hepatic decompensation at the time of enrollment
Patients taking probenecid medication within 1 week prior to study day 1 or during the study

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 of this study was to define the pharmacokinetics of oseltamivir and oseltamivir carboxylate (OC) and evaluate the safety profile following IV administration of oseltamivir phosphate (OP) in infants less than 1 year of age with influenza;Secondary Objective: The secondary objectives of this study were as follows: To evaluate viral load and shedding, To evaluate all isolates for phenotypic and, where necessary, genotypic resistance ;Primary end point(s): Steady-state pharmacokinetics parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate<br>Safety Profile: AEs, vital signs, laboratory parameters ;Timepoint(s) of evaluation of this end point: Steady-state pharmacokinetics parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate [Time Frame: Multiple sampling day 3 or 4 ]<br>Safety Profile: AEs, vital signs, laboratory parameters [ Time Frame: Days 1-11 and on follow up days 15 and 30 ]

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Viral load and shedding<br>Development of resistance to oseltamivir ;Timepoint(s) of evaluation of this end point: Viral load and shedding [ Time Frame: Assessment days 1, 3 or 4, 6, 11, and optional at days 15 and 30 ]<br>Development of resistance to oseltamivir [ Time Frame: Assessment days 1, 3 or 4, 6, 11, and at days 15 and 30 if samples are collected]