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A Study of Tamiflu (Oseltamivir) for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients.

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: oseltamivir [Tamiflu] (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This 2 arm study will evaluate the efficacy and safety of Tamiflu in the seasonal prophylaxis of influenza in immunocompromised patients (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive Tamiflu syrup or capsules 30mg-75mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Clinical Details

Official title: A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: No. of Patients With Laboratory-confirmed Clinical Influenza

Secondary outcome:

No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture

No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Eligibility

Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- males or females >=1 year of age;

- negative rapid diagnostic test for influenza at baseline;

- immunocompromised subject (liver and/or kidney recipient or allogenic HSCT).

Exclusion Criteria:

- symptoms suggestive of influenza-like illness;

- influenza vaccination in 6 weeks prior to randomization;

- positive rapid diagnostic test for influenza;

- SOT within 6 months of randomization;

- antiviral treatment for influenza in 2 weeks prior to randomization.

Locations and Contacts

Aalst 9300, Belgium

Bruxelles 1090, Belgium

Bruxelles 1200, Belgium

Edegem 2650, Belgium

Leuven 3000, Belgium

Brno 639 00, Czech Republic

Tallinn 10617, Estonia

Tartu 51014, Estonia

Paris 75019, France

Paris 75475, France

Paris 75743, France

Toulouse 31054, France

Tours 37044, France

Aachen 52057, Germany

Berlin 10098, Germany

Hamburg 20251, Germany

Heidelberg 69120, Germany

München 80336, Germany

München 81675, Germany

Budapest 1097, Hungary

Pecs 7624, Hungary

Szeged 6720, Hungary

Jerusalem 91120, Israel

Petach Tikva 49100, Israel

Ramat Gan 52621, Israel

Padova 35128, Italy

Pavia 27100, Italy

Roma 00168, Italy

Kaunas 50009, Lithuania

Vilnius 08661, Lithuania

Bialystok 15-540, Poland

Lodz 90-153, Poland

Szczecin 70-111, Poland

Warszawa 02-006, Poland

Warszawa 04-730, Poland

Madrid 28006, Spain

Madrid 28040, Spain

Birmingham B15 2TH, United Kingdom

Edinburgh EH16 4SA, United Kingdom

Birmingham, Alabama 35233, United States

Edmonton, Alberta T6G 2B7, Canada

Little Rock, Arkansas 72202, United States

Coquitlam, British Columbia V3K 3P4, Canada

Stanford, California 94305, United States

Denver, Colorado 80262, United States

Hartford, Connecticut 06106-3316, United States

Newark, Delaware 19718, United States

St Petersburg, Florida 33701, United States

Atlanta, Georgia 30309, United States

Augusta, Georgia 30912, United States

Chicago, Illinois 60611, United States

Chicago, Illinois 60612, United States

New Orleans, Louisiana 70121, United States

Winnipeg, Manitoba R3E 3P4, Canada

Detroit, Michigan 48201, United States

Detroit, Michigan 48202-2689, United States

Brooklyn Center, Minnesota 55430, United States

Missoula, Montana 59802, United States

Camden, New Jersey 08103, United States

Hackensack, New Jersey 07601, United States

Livingston, New Jersey 07039, United States

Newark, New Jersey 07112, United States

Buffalo, New York 14263, United States

New York, New York 10032, United States

New York, New York 10023, United States

Chapel Hill, North Carolina 27599-7211, United States

Charlotte, North Carolina 28207, United States

Durham, North Carolina 27705, United States

Cincinnati, Ohio 45267, United States

Cleveland, Ohio 44195, United States

Oklahoma City, Oklahoma 73112-44A1, United States

London, Ontario N6A 5A5, Canada

Hershey, Pennsylvania 17033, United States

Philadelphia, Pennsylvania 19104, United States

Pittsburgh, Pennsylvania 15213, United States

Saskatoon, Saskatchewan S7M 0Z9, Canada

Dallas, Texas 75203, United States

Houston, Texas 77030, United States

Additional Information

Clinical Study Report Synopsis


Last updated: July 30, 2010

Page last updated: August 23, 2015

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