A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection
Completed · Phase 1
Conditions studied: Influenza
In brief
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.
Key facts
- Study ID
- NCT01715909
- Run by
- Hoffmann-La Roche
- People needed
- 20
- Starts
- 2014-01-22
- Expected to finish
- 2018-06-17
- Last updated by the study team
- 2018-10-16
Who can join
Age: any, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 (</=) 96 hours between onset of ILI and first dose of study drug
You may not qualify if…
- 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
Where it is running
- Lucile Packard Child Hosp; Pediatric Pulmonary Division — Palo Alto, California, United States
- The Children's Hospital; Pediatric Infectious Diseases — Aurora, Colorado, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- SUNY Upstate Medical University — Syracuse, New York, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- UZ Brussel — Brussels, Belgium
- Cliniques Universitaires St-Luc — Brussels, Belgium
- UZ Leuven Gasthuisberg — Leuven, Belgium
- Hospital Erasto Gaertner — Curitiba, Paraná, Brazil
- Hospital São Lucas da PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
- Graacc-Grupo de Apoio ao adolescente e a crianca com cancer — São Paulo, São Paulo, Brazil
- Casa de Saúde Santa Marcelina — São Paulo, São Paulo, Brazil
- Children'S Hospital of Eastern Ontario — Ottawa, Ontario, Canada
- Hospital For Sick Children; Infectious Disease Dept — Toronto, Ontario, Canada
- McGill University; Montreal Children's Hospital; Oncology — Montreal, Quebec, Canada
- Hospital Dr. Gustavo Fricke — Viña del Mar, Chile
- Centro Medico Imbanaco — Cali, Colombia
- Fundacion Clinica Valle de Lili, Department Rheumatology — Cali, Colombia
- Turun yliopistollinen keskussairaala — Turku, Finland
- Charité - Universitätsmedizin Berlin;Klinik für Allgemeine Pädiatrie — Berlin, Germany
- Universitatsklinikum Frankfurt — Frankfurt, Germany
- Dr. Von Haunersches Kinderspital — München, Germany
- Universitätsklinikum Münster — Münster, Germany
Full record on ClinicalTrials.gov
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