A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 1 - Any |
| Updated: | 7/14/2018 |
| Start Date: | February 4, 2008 |
| End Date: | May 2, 2017 |
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.
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:
- Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours
prior to first dose
- Immunocompromised participants with primary or secondary immunodeficiency
- Symptoms suggestive of influenza-like illness
- Use of an effective contraceptive, as specified by protocol; women of childbearing
potential cannot be pregnant or breastfeeding
Exclusion Criteria:
- Influenza vaccination with live attenuated vaccine in the 2 weeks prior to
randomization
- Antiviral treatment for influenza in 2 weeks prior to randomization
- Severe hepatic impairment
- Any current renal replacement therapy
- Any gastrointestinal disorders which may interfere with the absorption of oseltamivir
- Participation in a study with an investigational drug from 4 weeks prior to study
start until study end
We found this trial at
61
sites
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of South Florida The University of South Florida is a high-impact, global research university...
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500 South State Street
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
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1365 Clifton Road
Atlanta, Georgia 30322
Atlanta, Georgia 30322
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1430 John Wesley Gilbert Drive
Augusta, Georgia 30912
Augusta, Georgia 30912
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655 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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1530 3rd Avenue South
Birmingham, Alabama 35233
Birmingham, Alabama 35233
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251 East Huron Street
Chicago, Illinois 60611
Chicago, Illinois 60611
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1753 W Congress Pkwy
Chicago, Illinois 60612
Chicago, Illinois 60612
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3410 Worth Street
Dallas, Texas 75246
Dallas, Texas 75246
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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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4100 John R Street
Detroit, Michigan 48201
Detroit, Michigan 48201
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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1515 Holcombe Boulevard
Houston, Texas 77030
Houston, Texas 77030
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3601 4th Street
Lubbock, Texas 79430
Lubbock, Texas 79430
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3300 N.W. Expressway
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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3601 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
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501 6th Avenue South
Saint Petersburg, Florida 33701
Saint Petersburg, Florida 33701
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50 North Medical Drive
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
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4502 Medical Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
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Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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