A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection
- South Africa
- United States
NCT01715909 2012-002633-11 NV25719
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
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.
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
- Male or female children, <13 years of age
- Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral culture positive for influenza
- Symptoms/signs suggestive of influenza like illness (ILI)
- Less than or equal to (</=) 96 hours between onset of ILI and first dose of study drug
- 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
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