Skip to main content
OpenTrials
Completed

NCT Number: NCT01033734

A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Petah Tikva, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children, 1-12 years of age
  • diagnosis of influenza
  • duration of influenza symptoms </=96 hours prior to first dose of study drug

Exclusion criteria

  • evidence of severe hepatic decompensation
  • patients taking probenecid within 1 week prior to first dose of study drug

Treatment and study plan

oseltamivir [Tamiflu]

Drug

5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.

Primary outcomes

  1. Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1

    Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.

  2. AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2

    Time frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  3. AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3

    Time frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  4. AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4

    Time frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  5. AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5

    Time frame: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  6. Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1

    Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion

  7. Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2

    Time frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  8. Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3

    Time frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  9. Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4

    Time frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  10. Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5

    Time frame: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

Secondary outcomes

  1. Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate

    Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  2. Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate

    Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  3. Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate

    Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  4. Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate

    Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  5. Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate

    Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  6. Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate

    Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

  7. Participants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values

    Time frame: Baseline, Day 1, 6 and 30

    IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either >=5 times change in the NAI IC50 visit value from the Reference value at a visit, >=5 times change in the NAI IC50 Visit value from the Baseline value.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir (Tamiflu) in the Treatment of Children 1 to 12 Years of Age With Influenza Infection

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2009
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.