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

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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:

- 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
655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
343
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Baltimore, MD
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
643
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Boston, MA
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
822
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Tampa, FL
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500 South State Street
Ann Arbor, Michigan 48109
164
mi
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Ann Arbor, MI
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432
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Atlanta, GA
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1365 Clifton Road
Atlanta, Georgia 30322
432
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Atlanta, GA
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1430 John Wesley Gilbert Drive
Augusta, Georgia 30912
452
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Augusta, GA
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1154
mi
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Aurora, CO
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Beverly Hills, California 90211
1979
mi
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Beverly Hills, CA
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1530 3rd Avenue South
Birmingham, Alabama 35233
492
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Birmingham, AL
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492
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Birmingham, AL
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5384
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Buenos Aires,
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Burbank, California 91505
1972
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Burbank, CA
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1600 Haddon Avenue
Camden, New Jersey 08103
419
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Camden, NJ
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525
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Charleston, SC
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Charlotte, North Carolina 28210
354
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Charlotte, NC
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274
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Chicago, IL
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1753 W Congress Pkwy
Chicago, Illinois 60612
276
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Chicago, IL
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274
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Chicago, IL
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97
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Cincinnati, OH
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9500 Euclid Avenue
Cleveland, Ohio 44195
129
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Cleveland, OH
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3410 Worth Street
Dallas, Texas 75246
910
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Dallas, TX
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911
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Dallas, TX
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910
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Dallas, TX
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
911
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4100 John R Street
Detroit, Michigan 48201
164
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Detroit, MI
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2799 West Grand Boulevard
Detroit, Michigan 48202
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Detroit, MI
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Detroit, MI
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
476
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Hackensack, NJ
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
337
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Hershey, PA
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Houston, Texas 77030
995
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Houston, TX
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Houston, TX
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Lansing, Michigan 48917
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Lansing, MI
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Los Angeles, California 90069
1978
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Los Angeles, CA
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757 Westwood Plaza
Los Angeles, California 90095
1982
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Los Angeles, CA
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1130
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Lubbock, TX
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Matthews, North Carolina 28105
357
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Matthews, NC
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1991 Marcus Avenue
New Hyde Park, New York 11042
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New Hyde Park, NY
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New Orleans, Louisiana 70112
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New Orleans, LA
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New York, NY
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Newark, Delaware 19713
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Newark, DE
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3300 N.W. Expressway
Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Orlando, Florida 32804
792
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
416
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Philadelphia, PA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Philadelphia, Pennsylvania 19104
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3601 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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19 West Hargett Street
Raleigh, North Carolina 27609
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2042
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Sacramento, CA
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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501 6th Avenue South
Saint Petersburg, Florida 33701
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50 North Medical Drive
Salt Lake City, Utah 84132
1510
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4502 Medical Drive
San Antonio, Texas 78229
1138
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1982
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San Francisco, CA
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6200 Southwest 73rd Street
South Miami, Florida 33143
997
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South Miami, FL
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563
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Springfield, MA
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Tamarac, Florida 33319
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2401 South 31st Street
Temple, Texas 76508
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
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Trumbull, Connecticut 06611
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
306
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