A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection

Status:	Completed
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any - 12
Updated:	10/18/2018
Start Date:	January 22, 2014
End Date:	June 17, 2018

An Open-Label, Randomized, Adaptive, Two-Arm, Multicenter Trial to Evaluate Pharmacokinetics And Pharmacodynamics of Two Doses of Oseltamivir (Tamiflu®) in The Treatment Of Influenza in Immunocompromised Children Less Than 13 Years Of Age, With Confirmed Influenza Infection

This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the
pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children,
less than (<) 13 years of age, with confirmed influenza infection. Participants will be
randomized to receive either the standard dose or triple dose of oseltamivir orally daily for
a minimum of 5 days and up to 20 days. Infants <1 year of age will be randomized to the
standard dose arm only.

Inclusion Criteria:

- Male or female children, <13 years of age

- Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral
culture positive for influenza

- Immunocompromised

- Symptoms/signs suggestive of influenza like illness (ILI)

- Less than or equal to (
Exclusion Criteria:

- Clinical evidence of severe hepatic impairment

- Infants with post-menstrual age (PMA) <36 weeks

- Clinical evidence of significant renal impairment

- Allergy to oseltamivir or excipients

- Hereditary fructose intolerance

- Received anti-viral treatment with activity against influenza (for example amantadine,
rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or
probenecid medication within 2 weeks prior to randomization

We found this trial at

sites

SUNY Upstate Medical University

750 East Adams Street
Syracuse, New York 13210

from

Syracuse, NY