Clinical trial NCT00545532: A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
Official title: A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 228
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to Day 40
measure: Percentage of Participants Who Developed Viral Resistance to Oseltamivir
timeFrame: Baseline up to Day 40
measure: Percentage of Participants With Tissue Rejection or Graft Versus Host Disease (GVHD)
timeFrame: Baseline up to Day 40
Secondary outcomes:
measure: Time to Resolution (TTR) of All Clinical Influenza Symptoms
timeFrame: Baseline up to Day 40
measure: Total Symptom Score Area Under the Efficacy Curve (AUE)
timeFrame: Baseline up to Day 40
measure: Time to Resolution of Fever
timeFrame: Baseline up to Day 40
measure: Change From Baseline in Viral Load Assessed by Culture
timeFrame: Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.
measure: Percentage of Participants With Viral Shedding Assessed by Culture Over Time
timeFrame: Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.
measure: Time to Cessation of Viral Shedding by Cell Culture
timeFrame: Baseline up to Day 40
measure: Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
timeFrame: Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.
measure: Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
timeFrame: Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.
measure: Time to Cessation of Viral Shedding by RT-PCR
timeFrame: Baseline up to Day 40
measure: Percentage of Participants With Persistent Viral Shedding
timeFrame: Baseline to Day 11 (EOT)
measure: Percentage of Participants Who Developed Secondary Illness
timeFrame: Baseline up to Day 40
measure: Percentage of Participants Who Initiated Antibiotic Treatment
timeFrame: Baseline up to Day 40
measure: Percentage of Participants Hospitalized
timeFrame: Baseline up to Day 40
measure: Duration of Hospitalization
timeFrame: Baseline up to Day 40
measure: Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics : Area Under the Concentration-Time Curve From 0 to 12 Hours (AUC0-12) at Steady State of Oseltamivir in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
measure: Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children
timeFrame: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uni of Alabama At Birmingham; Division of Nephrology
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham; Pediatric Nephrology
state: Alabama
city: Beverly Hills
country: United States
facility: Pacific Oaks Medical Group
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Los Angeles
country: United States
facility: AIDS Research Alliance
state: California
city: Los Angeles
country: United States
facility: UCLA Medical center Medicine/Nephrology
state: California
city: Sacramento
country: United States
facility: University of California Davis Health System
state: California
city: San Francisco
country: United States
facility: CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi
state: California
city: Aurora
country: United States
facility: University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan
state: Colorado
city: Trumbull
country: United States
facility: New England Research Associates
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Saint Petersburg
country: United States
facility: All Children'S Hospital; Pediatric Blood & Marrow Transplant Program
state: Florida
city: South Miami
country: United States
facility: Kendall South Medical Center Inc.
state: Florida
city: Tamarac
country: United States
facility: Vita Research Solutions, Inc
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital; Transplant Services
state: Georgia
city: Atlanta
country: United States
facility: EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia; Medicine/ Nephrology
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush Uni Medical Center; Medicine/ Section of Infectious Diseases
state: Illinois
city: Chicago
country: United States
facility: University of Chicago; Infectious Disease
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Brigham & Women'S Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Western New England Renal & Transplant Associates, P.C.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System; Gastroenterology
state: Michigan
city: Detroit
country: United States
facility: Wayne State University School of Medicine
state: Michigan
city: Lansing
country: United States
facility: Beals Institute PC
state: Michigan
city: Saint Louis
country: United States
facility: Washington University; Wash Uni. Sch. Of Med
state: Missouri
city: Camden
country: United States
facility: Our Lady of Lourdes Medical Center; Transplant Dept
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Hyde Park
country: United States
facility: Long Island Jewish/North Shore Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center; Division of Liver Diseases
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research PLLC
state: North Carolina
city: Matthews
country: United States
facility: Novant Health Pulmonary and Critical Care
state: North Carolina
city: Raleigh
country: United States
facility: Duke University Health Systems
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Uni of Cincinnati Medical Center; Nephrology & Hypertension
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation; Infectious Disease
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University; College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Uni of Pennsylvania; Infectious Diseases
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children'S Hospital of Pittsburgh; Infectious Disease
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina; Pediatric Cardiology
state: South Carolina
city: Dallas
country: United States
facility: Children'S Medical Center of Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center Transplant Administration
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center; Pediatrics Dept.
state: Texas
city: Dallas
country: United States
facility: Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Houston
country: United States
facility: M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center; Department of Urology
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center Transplant center
state: Texas
city: Temple
country: United States
facility: Scott and White Division of Nephrology Dept of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Science Center Gastroenterology
state: Utah
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos Juan Antonio Fernandez; infectología
city: Buenos Aires
country: Argentina
facility: Instituto Medico Platense
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital General de Agudos Dr. Ignacio Pirovano
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Santa Fe
country: Argentina
facility: Hospital de Niños Dr. Orlando Alassia
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis Aalst
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Hospital Erasme; Neurologie
city: Rio de Janeiro
country: Brazil
facility: Fiocruz - Fundação Oswaldo Cruz
state: RJ
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz; Oncologia
state: SP
city: Sao Paulo
country: Brazil
facility: Iop - Graacc - Unifesp
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP
state: SP
city: Plovdiv
country: Bulgaria
facility: UMHA - Sv. Georgi; Clinic of Nephrology & Haemodialysis
city: Plovdiv
country: Bulgaria
facility: UMHAT Sv. Georgi, EAD; Clinic of Infectious Diseases
city: Sofia
country: Bulgaria
facility: Mhat Alexandrovska Ead ; Clinic of Nephrology & Transplantation, Uni Hospital
city: Sofia
country: Bulgaria
facility: Specialized Hospital for children with oncohaematologica Diseases; Dept. Of Transplantations
city: Winnipeg
country: Canada
facility: Uni of Manitoba; Faculty of Medicine
state: Manitoba
city: Saskatoon
country: Canada
facility: St Paul'S
state: Saskatchewan
city: Santiago
country: Chile
facility: Hospital Luis Calvo Mackenna; Unidad de Investigacion
city: Santiago
country: Chile
facility: Hospital Dr. Sotero del Rio
city: Viña Del Mar Valparaiso
country: Chile
facility: Centro de Investigaciones Clinicas Viña del Mar
city: Barranquilla
country: Colombia
facility: Infectologos Asociados
city: Bogota
country: Colombia
facility: Simedics Ips
city: Cali
country: Colombia
facility: Centro de Investigaciones Clinicas S.A.S
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia - Instituto del Corazón
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
city: Plzen
country: Czechia
facility: Fakultni Nemocnice; Hemato-Oncology
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF
city: Praha
country: Czechia
facility: The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf
city: Tabor
country: Czechia
facility: KASMED, s.r.o.; Alergologie a klinicka imunologie
city: Terezin
country: Czechia
facility: Revmatologicka Ambulance-Terezin
city: Zlin
country: Czechia
facility: Revmatologicka ambulance
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital; Nephrology
city: Tallinn
country: Estonia
facility: North Estonia medical Centre; Hematology
city: Tartu
country: Estonia
facility: Tartu Uni Clinics; Clinic of Surgery & Internal Medicine Dept of Nephrology
city: Tartu
country: Estonia
facility: Tartu Uni Hospital; Hematology - Oncology Clinic
city: Tartu
country: Estonia
facility: Tartu University Hospital; Department of Infectious Diseases
city: Lyon
country: France
facility: Centre Hospitalier de la Croix Rousse
city: Paris
country: France
facility: Hopital Robert Debre; Pediatric Hematology Dept
city: Paris
country: France
facility: Hopital Saint Louis; Service de Nephrologie - Transplantation
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou; Service de Nephrologie
city: Toulouse
country: France
facility: Hopital Rangueil; Nephrologie
city: Tours
country: France
facility: CHRU Bretonneau
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie
city: Berlin
country: Germany
facility: Charite - Campus Virchow Klinikum; Abteilung fuer Chirurgie
city: Essen
country: Germany
facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: UNI-Klinikum Heidelberg Chirurgische Klinik
city: Muenchen
country: Germany
facility: Ludwig-Maximilian-Universitaetsklinik; Med. Poliklinik/Infektiologie
city: Muenchen
country: Germany
facility: Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie
city: Ciudad de Guatemala
country: Guatemala
facility: Clinica Familiar Luis Angel Garcia
city: Ciudad de Guatemala
country: Guatemala
facility: CERICAP
city: Guatemala City
country: Guatemala
facility: Centro de Investigaciones Pediatricas
city: Guatemala City
country: Guatemala
facility: Hospital Roosevelt Guatemala; Clinica de Infecciosas
city: Guatemala
country: Guatemala
facility: Unidad Nacional de Oncologia Pediatrica
city: Budapest
country: Hungary
facility: Fov.Onk.Egyesitett Szt. Istvan es Szt Laszlo Korh.-Rend.Int.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Orvos- és Egészségtudományi Centrum;
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Korhaz; Hematologia
city: Gyula
country: Hungary
facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
city: Gyula
country: Hungary
facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szeged
country: Hungary
facility: University of Szeged; Transplantation Department
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.
city: Haifa
country: Israel
facility: Rambam Health Care Campus; Hematology
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept.
city: Petach Tikva
country: Israel
facility: Rabin MC- Belinson campus
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation
city: Petach Tikva
country: Israel
facility: Rabin Medical Center; Liver Inst.
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Hematology BMT & CBB
city: Tel Aviv
country: Israel
facility: Sourasky MC; Transplant Unit
city: Tel Hashomer
country: Israel
facility: Chaim Sheba MC; Pediatric Hematology Oncology
city: Parma
country: Italy
facility: Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali
state: Emilia-Romagna
city: Roma
country: Italy
facility: POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
state: Lazio
city: Roma
country: Italy
facility: I.N.M.I. L. Spallanzani IRCCS
state: Lazio
city: Brescia
country: Italy
facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Divisione Malattie Infettive
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi
state: Molise
city: Riga
country: Latvia
facility: Latvia Transplantation Center P. Stradina Hospital; Transplantation
city: Riga
country: Latvia
facility: Children's Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Kaunas Clinics Public Institution; Clinic of Nephrology
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital; Public Institution
city: Siauliai
country: Lithuania
facility: Siauliai Republican Hospital Public Institution
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic
city: Vilnius
country: Lithuania
facility: Republican Tuberculosis and Infectious Diseases University H
city: Cuautitlan Izcalli
country: Mexico
facility: Phylaxis Clinical Research S de RL de CV
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; Infectología piso 7
city: Mexico
country: Mexico
facility: Centro de Investigacion Clínica GRAMEL S.C
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia
city: Mexico
country: Mexico
facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
city: Monterrey
country: Mexico
facility: Hospital Universitario de Monterrey; Infectologia
city: Zapopan
country: Mexico
facility: Hospital de Especialidades del Centro Medico Puerta de Hierr
city: Bialystok
country: Poland
facility: Wojewodzki Szp.Specjalistyczny im.K.Dluskiego w Bialymstoku
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: SPZOZ Szpital Uniw W Krakowie
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szp Klin; nr1 im.N.Barlickiego UM
city: Szczecin
country: Poland
facility: SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie
city: Warszawa
country: Poland
facility: Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology
city: Warszawa
country: Poland
facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego
city: Wroclaw
country: Poland
facility: SP Szpital Kliniczny Nr 1 we Wroclawiu
city: Wroclaw
country: Poland
facility: ALL-MED Specjalistyczna Opieka Medyczna
city: Bucharest
country: Romania
facility: Institutul de Urologie Si Transplant Renal Fundeni
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Durban
country: South Africa
facility: Londisizwe Research Centre
city: Durban
country: South Africa
facility: Sebastian Peter
city: Durban
country: South Africa
facility: Dr V Naidoo Private Practice
city: Durban
country: South Africa
facility: Govind U
city: Johannesburg
country: South Africa
facility: Soweto CTC - Dr Phoshoko site
city: Johannesburg
country: South Africa
facility: Soweto CTC - Dr Mushwana site
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research
city: Middelburg
country: South Africa
facility: Mzansi Ethical Research Centre
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre
city: Port Elizabeth
country: South Africa
facility: Global Clinical Trials Port Elizabeth
city: Pretoria
country: South Africa
facility: Kalafong Hospital; Pathology
city: Pretoria
country: South Africa
facility: Emmed Research
city: Pretoria
country: South Africa
facility: Synexus Clinical Research Centres SA Stanza Bopape
city: Soweto
country: South Africa
facility: Soweto Clinical Trial Centre
city: Tygerberg; Cape Town
country: South Africa
facility: Tygerberg Hospital Pediatrics and Child Health
city: Welkom
country: South Africa
facility: Welkom Clinical Trial Centre
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: LA Coruña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos; Servicio de Nefrologia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Enfermedades Infecciosas
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; HIV Unit
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Pediatria
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Hepatología y Trasplantes
city: Madrid
country: Spain
facility: Hospital Universitario la Paz; Servicio de Enfermedades Infecciosas - HIV unit
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich; Klinik für Nephrologie
city: Kiev
country: Ukraine
facility: Ukrainian Pediatric Specialized Hospital of Ministry of Health of Ukraine Dept of BMT
city: Kiev
country: Ukraine
facility: Institute of Nephrology AMS; Dept of Nephrology & dialysis
city: Lugnansk
country: Ukraine
facility: Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed
city: Zaporozhye
country: Ukraine
facility: Zaporozhye State Medical University; Dept of Transplantology
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary; Renal Transplant Unit
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital; Transplant Unit
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.