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

Influenza Clinical Trial

Official title:

An Open-label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir in the Treatment of Infants Less Than One Year of Age With Influenza Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01053663
• Other study ID #: NP25138
• Status: Active, not recruiting
• Phase: Phase 1
• First received: January 20, 2010
• Last updated: May 13, 2013
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days. Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 365 Days

Eligibility

Inclusion Criteria:

• Infant patients

• Date of birth to date of enrollment is <1 year

• Diagnosis of influenza

• Duration of influenza symptoms </=96 hours prior to first dose

• - Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days (5 or 6 doses of study drug)

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Tamiflu
10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady-state pharmacokinetics parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate		Multiple sampling day 3 or 4	No
Primary	Safety Profile: AEs, vital signs, laboratory parameters		Days 1-11 and on follow up days 15 and 30	No
Secondary	Viral load and shedding		Assessment days 1, 3 or 4, 6, 11, and optional at days 15 and 30	No
Secondary	Development of resistance to oseltamivir		Assessment days 1, 3 or 4, 6, 11, and at days 15 and 30 if samples are collected	No