Research

Influenza Treatment in Immunocompromised Patients – Phase IV

Treatment of Immunocompromised Patients with Conventional and High Dose Oseltamivir

Protocol Description

The purpose of this multi-center interventional study is to evaluate the efficacy of oseltamivir, also known by the trade name Tamiflu, for the treatment of influenza (flu) in transplant recipients. Researchers are investigating whether a higher dose of the study drug than what is conventionally given can lead to faster resolution of flu in this patient group, whose immune systems are compromised by immunosuppressant treatment.
 
Study Level: Phase IV
 

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to transplant recipients (liver, kidney, liver and kidney, allogenic haematopoietic stem cell transplant), who are 1 year of age and older who are shown to be positive for flu by a rapid diagnostic test at baseline.
Males: Age 1 and older
Females: Age 1 and older
 
Requirements
Following initial screening examination, participants will be randomly divided into groups that will be given the study drug in either a conventional dose (based on age and weight) or a high dose. Blood testing and other examinations will be conducted during follow up visits.
Visits: Up to 6
Duration: 1 month
 
Status: Open for Enrollment
 
Source(s) of Support
Hoffmann-La Roche
 

Primary Investigator(s)

Marian G. Michaels, MD, MPH

Contact Information

For information, or to enroll, please contact:
Marian G. Michaels, MD, MPH
412-692-7438
Noreen Jeffrey, RN
412-692-6786

Last Update
January 20, 2014
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Last Update
January 20, 2014
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