A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
NCT ID: NCT00545532
Last Updated: 2018-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
228 participants
INTERVENTIONAL
2008-02-04
2017-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Conventional dose
Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
oseltamivir
Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days
placebo
Placebo matched to oseltamivir po twice daily for 10 days
Double dose
Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
oseltamivir
Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days
placebo
Placebo matched to oseltamivir po twice daily for 10 days
Interventions
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oseltamivir
Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days
placebo
Placebo matched to oseltamivir po twice daily for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Uni of Alabama At Birmingham; Division of Nephrology
Birmingham, Alabama, United States
University of Alabama at Birmingham; Pediatric Nephrology
Birmingham, Alabama, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Providence Clinical Research
Burbank, California, United States
AIDS Research Alliance
Los Angeles, California, United States
UCLA Medical center Medicine/Nephrology
Los Angeles, California, United States
University of California Davis Health System
Sacramento, California, United States
CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi
San Francisco, California, United States
University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan
Aurora, Colorado, United States
New England Research Associates
Trumbull, Connecticut, United States
Christiana Care Health System
Newark, Delaware, United States
Omega Research Consultants
Orlando, Florida, United States
Kendall South Medical Center Inc.
South Miami, Florida, United States
All Children'S Hospital; Pediatric Blood & Marrow Transplant Program
St. Petersburg, Florida, United States
Vita Research Solutions, Inc
Tamarac, Florida, United States
University of South Florida
Tampa, Florida, United States
Piedmont Hospital; Transplant Services
Atlanta, Georgia, United States
EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center
Atlanta, Georgia, United States
Medical College of Georgia; Medicine/ Nephrology
Augusta, Georgia, United States
Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine
Chicago, Illinois, United States
Rush Uni Medical Center; Medicine/ Section of Infectious Diseases
Chicago, Illinois, United States
University of Chicago; Infectious Disease
Chicago, Illinois, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Brigham & Women'S Hospital
Boston, Massachusetts, United States
Western New England Renal & Transplant Associates, P.C.
Springfield, Massachusetts, United States
Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease
Ann Arbor, Michigan, United States
Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building
Detroit, Michigan, United States
Henry Ford Health System; Gastroenterology
Detroit, Michigan, United States
Wayne State University School of Medicine
Detroit, Michigan, United States
Beals Institute PC
Lansing, Michigan, United States
Washington University; Wash Uni. Sch. Of Med
St Louis, Missouri, United States
Our Lady of Lourdes Medical Center; Transplant Dept
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Long Island Jewish/North Shore Hospital
New Hyde Park, New York, United States
Mount Sinai Medical Center; Division of Liver Diseases
New York, New York, United States
DJL Clinical Research PLLC
Charlotte, North Carolina, United States
Novant Health Pulmonary and Critical Care
Matthews, North Carolina, United States
Duke University Health Systems
Raleigh, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Uni of Cincinnati Medical Center; Nephrology & Hypertension
Cincinnati, Ohio, United States
Cleveland Clinic Foundation; Infectious Disease
Cleveland, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Drexel University; College of Medicine
Philadelphia, Pennsylvania, United States
Uni of Pennsylvania; Infectious Diseases
Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Children'S Hospital of Pittsburgh; Infectious Disease
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina; Pediatric Cardiology
Charleston, South Carolina, United States
Children'S Medical Center of Dallas
Dallas, Texas, United States
Baylor University Medical Center Transplant Administration
Dallas, Texas, United States
UT Southwestern Medical Center; Pediatrics Dept.
Dallas, Texas, United States
Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation
Dallas, Texas, United States
The Methodist Hospital
Houston, Texas, United States
M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health
Houston, Texas, United States
Texas Tech University Health Sciences Center; Department of Urology
Lubbock, Texas, United States
University of Texas Health Science Center Transplant center
San Antonio, Texas, United States
Scott and White Division of Nephrology Dept of Medicine
Temple, Texas, United States
University of Utah Health Science Center Gastroenterology
Salt Lake City, Utah, United States
Hospital General de Agudos Juan Antonio Fernandez; infectología
Buenos Aires, , Argentina
Instituto Medico Platense
Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires, , Argentina
Hospital General de Agudos Dr. Ignacio Pirovano
Ciudad Autonoma Buenos Aires, , Argentina
Hospital Italiano de La Plata
La Plata, , Argentina
Hospital de Niños Dr. Orlando Alassia
Santa Fe, , Argentina
Onze Lieve Vrouwziekenhuis Aalst
Aalst, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Hospital Erasme; Neurologie
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
Fiocruz - Fundação Oswaldo Cruz
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Alemao Oswaldo Cruz; Oncologia
São Paulo, São Paulo, Brazil
Iop - Graacc - Unifesp
São Paulo, São Paulo, Brazil
Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
São Paulo, São Paulo, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
UMHA - Sv. Georgi; Clinic of Nephrology & Haemodialysis
Plovdiv, , Bulgaria
UMHAT Sv. Georgi, EAD; Clinic of Infectious Diseases
Plovdiv, , Bulgaria
Mhat Alexandrovska Ead ; Clinic of Nephrology & Transplantation, Uni Hospital
Sofia, , Bulgaria
Specialized Hospital for children with oncohaematologica Diseases; Dept. Of Transplantations
Sofia, , Bulgaria
Uni of Manitoba; Faculty of Medicine
Winnipeg, Manitoba, Canada
St Paul'S
Saskatoon, Saskatchewan, Canada
Hospital Luis Calvo Mackenna; Unidad de Investigacion
Santiago, , Chile
Hospital Dr. Sotero del Rio
Santiago, , Chile
Centro de Investigaciones Clinicas Viña del Mar
Viña Del Mar Valparaiso, , Chile
Infectologos Asociados
Barranquilla, , Colombia
Simedics Ips
Bogotá, , Colombia
Centro de Investigaciones Clinicas S.A.S
Cali, , Colombia
Fundacion Cardiovascular de Colombia - Instituto del Corazón
Floridablanca, , Colombia
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
Brno, , Czechia
Fakultni Nemocnice; Hemato-Oncology
Pilsen, , Czechia
The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf
Prague, , Czechia
Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF
Prague, , Czechia
KASMED, s.r.o.; Alergologie a klinicka imunologie
Tábor, , Czechia
Revmatologicka Ambulance-Terezin
Terezín, , Czechia
Revmatologicka ambulance
Zlín, , Czechia
West Tallinn Central Hospital; Nephrology
Tallinn, , Estonia
North Estonia medical Centre; Hematology
Tallinn, , Estonia
Tartu Uni Clinics; Clinic of Surgery & Internal Medicine Dept of Nephrology
Tartu, , Estonia
Tartu Uni Hospital; Hematology - Oncology Clinic
Tartu, , Estonia
Tartu University Hospital; Department of Infectious Diseases
Tartu, , Estonia
Centre Hospitalier de la Croix Rousse
Lyon, , France
Hopital Robert Debre; Pediatric Hematology Dept
Paris, , France
Hopital Saint Louis; Service de Nephrologie - Transplantation
Paris, , France
Hopital Europeen Georges Pompidou; Service de Nephrologie
Paris, , France
Hopital Rangueil; Nephrologie
Toulouse, , France
CHRU Bretonneau
Tours, , France
Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie
Aachen, , Germany
Charite - Campus Virchow Klinikum; Abteilung fuer Chirurgie
Berlin, , Germany
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Essen, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
UNI-Klinikum Heidelberg Chirurgische Klinik
Heidelberg, , Germany
Ludwig-Maximilian-Universitaetsklinik; Med. Poliklinik/Infektiologie
München, , Germany
Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV
München, , Germany
Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie
Münster, , Germany
Clinica Familiar Luis Angel Garcia
Guatemala City, , Guatemala
CERICAP
Guatemala City, , Guatemala
Centro de Investigaciones Pediatricas
Guatemala City, , Guatemala
Hospital Roosevelt Guatemala; Clinica de Infecciosas
Guatemala City, , Guatemala
Unidad Nacional de Oncologia Pediatrica
Guatemala City, , Guatemala
Fov.Onk.Egyesitett Szt. Istvan es Szt Laszlo Korh.-Rend.Int.
Budapest, , Hungary
Debreceni Egyetem, Orvos- és Egészségtudományi Centrum;
Debrecen, , Hungary
Petz Aladar Megyei Korhaz; Hematologia
Győr, , Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
Gyula, , Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, , Hungary
Pecsi Tudomanyegyetem
Pécs, , Hungary
University of Szeged; Transplantation Department
Szeged, , Hungary
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok, , Hungary
Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.
Veszprém, , Hungary
Rambam Health Care Campus; Hematology
Haifa, , Israel
Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept.
Jerusalem, , Israel
Rabin MC- Belinson campus
Petah Tikva, , Israel
Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation
Petah Tikva, , Israel
Rabin Medical Center; Liver Inst.
Petah Tikva, , Israel
Chaim Sheba Medical Center; Hematology BMT & CBB
Ramat Gan, , Israel
Sourasky MC; Transplant Unit
Tel Aviv, , Israel
Chaim Sheba MC; Pediatric Hematology Oncology
Tel Litwinsky, , Israel
Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali
Parma, Emilia-Romagna, Italy
POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
Rome, Lazio, Italy
I.N.M.I. L. Spallanzani IRCCS
Rome, Lazio, Italy
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive
Brescia, Lombardy, Italy
ASST DI MONZA; Divisione Malattie Infettive
Monza, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi
Milano, Molise, Italy
Latvia Transplantation Center P. Stradina Hospital; Transplantation
Riga, , Latvia
Children's Clinical University Hospital
Riga, , Latvia
Kaunas Clinics Public Institution; Clinic of Nephrology
Kaunas, , Lithuania
Klaipeda University Hospital; Public Institution
Klaipėda, , Lithuania
Siauliai Republican Hospital Public Institution
Šiauliai, , Lithuania
Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
Vilnius, , Lithuania
Vilnius University Hospital Santariskiu Clinic
Vilnius, , Lithuania
Republican Tuberculosis and Infectious Diseases University H
Vilnius, , Lithuania
Phylaxis Clinical Research S de RL de CV
Cuautitlán Izcalli, , Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; Infectología piso 7
Guadalajara, , Mexico
Centro de Investigacion Clínica GRAMEL S.C
México, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia
México, , Mexico
INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
México, , Mexico
Hospital Universitario de Monterrey; Infectologia
Monterrey, , Mexico
Hospital de Especialidades del Centro Medico Puerta de Hierr
Zapopan, , Mexico
Wojewodzki Szp.Specjalistyczny im.K.Dluskiego w Bialymstoku
Bialystok, , Poland
NZOZ Vitamed
Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
SPZOZ Szpital Uniw W Krakowie
Krakow, , Poland
SPZOZ Uniwersytecki Szp Klin; nr1 im.N.Barlickiego UM
Lodz, , Poland
SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie
Szczecin, , Poland
Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology
Warsaw, , Poland
Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego
Warsaw, , Poland
SP Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, , Poland
ALL-MED Specjalistyczna Opieka Medyczna
Wroclaw, , Poland
Institutul de Urologie Si Transplant Renal Fundeni
Bucharest, , Romania
Josha Research
Bloemfontein, , South Africa
Londisizwe Research Centre
Durban, , South Africa
Sebastian Peter
Durban, , South Africa
Dr V Naidoo Private Practice
Durban, , South Africa
Govind U
Durban, , South Africa
Soweto CTC - Dr Phoshoko site
Johannesburg, , South Africa
Soweto CTC - Dr Mushwana site
Johannesburg, , South Africa
Newtown Clinical Research
Johannesburg, , South Africa
Mzansi Ethical Research Centre
Middelburg, , South Africa
Be Part Yoluntu Centre
Paarl, , South Africa
Global Clinical Trials Port Elizabeth
Port Elizabeth, , South Africa
Kalafong Hospital; Pathology
Pretoria, , South Africa
Emmed Research
Pretoria, , South Africa
Synexus Clinical Research Centres SA Stanza Bopape
Pretoria, , South Africa
Soweto Clinical Trial Centre
Soweto, , South Africa
Tygerberg Hospital Pediatrics and Child Health
Tygerberg; Cape Town, , South Africa
Welkom Clinical Trial Centre
Welkom, , South Africa
Hospital Universitari de Bellvitge; Servicio de Nefrologia
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, LA Coruña, Spain
Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Nefrologia
Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Enfermedades Infecciosas
Madrid, , Spain
Hospital Universitario 12 de Octubre; HIV Unit
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Pediatria
Madrid, , Spain
Hospital Universitario La Paz; Hepatología y Trasplantes
Madrid, , Spain
Hospital Universitario la Paz; Servicio de Enfermedades Infecciosas - HIV unit
Madrid, , Spain
Universitätsspital Zürich; Klinik für Nephrologie
Zurich, , Switzerland
Ukrainian Pediatric Specialized Hospital of Ministry of Health of Ukraine Dept of BMT
Kiev, , Ukraine
Institute of Nephrology AMS; Dept of Nephrology & dialysis
Kiev, , Ukraine
Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed
Lugnansk, , Ukraine
Zaporozhye State Medical University; Dept of Transplantology
Zaporizhzhya, , Ukraine
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Manchester Royal Infirmary; Renal Transplant Unit
Manchester, , United Kingdom
Nottingham City Hospital; Transplant Unit
Nottingham, , United Kingdom
Countries
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References
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Mitha E, Krivan G, Jacobs F, Nagler A, Alrabaa S, Mykietiuk A, Kenwright A, Le Pogam S, Clinch B, Vareikiene L. Safety, Resistance, and Efficacy Results from a Phase IIIb Study of Conventional- and Double-Dose Oseltamivir Regimens for Treatment of Influenza in Immunocompromised Patients. Infect Dis Ther. 2019 Dec;8(4):613-626. doi: 10.1007/s40121-019-00271-8. Epub 2019 Oct 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2006-002468-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NV20234
Identifier Type: -
Identifier Source: org_study_id
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