A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza
A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza
This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.
Inclusion Criteria:
Exclusion Criteria:
San Francisco, California 94115, United States
Aurora, Colorado 80045, United States
St. Petersburg, Florida 33701, United States
Chicago, Illinois 60611, United States
Chicago, Illinois 60612, United States
Springfield, Massachusetts 01107, United States
Ann Arbor, Michigan 48109-0378, United States
Detroit, Michigan 48201, United States
Oklahoma City, Oklahoma 73112-4481, United States
Charleston, South Carolina 29425, United States
Dallas, Texas TX 75246, United States
Houston, Texas 77030, United States
Lubbock, Texas 79430, United States
Ciudad Autonoma Buenos Aires, 1426, Argentina
Ciudad Autonoma Buenos Aires, 1430, Argentina
Sofia, 1527, Bulgaria
Viña Del Mar Valparaiso, 2520000, Chile
Prague, 12820, Czechia
Aachen, 52057, Germany
Petah Tikva, 49100, Israel
Rome, Lazio 00168, Italy
Milano, Molise 20122, Italy
Vilnius, 08661, Lithuania
Guadalajara, 44280, Mexico
Warsaw, 02-006, Poland
Warsaw, 04-730, Poland
Tygerberg; Cape Town, 7505, South Africa
L'Hospitalet de Llobregat, Barcelona 08907, Spain
Barcelona, 08035, Spain
Kiev, 01135, Ukraine
Lugnansk, 91045, Ukraine