AzTrials
AzTrials

Influenza, HumanPhase 3NCT00545532

A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

A Phase 3 study testing oseltamivir in people with Influenza, Human, run by Hoffmann-La Roche at 208 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Influenza, Human
What is being tested?
oseltamivir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
228 participants
Where
208 sitesin 26 countries
Study dates
4 Feb 2008to 2 May 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

208 sites in 26 countries.

208 sites in 26 countries

United States60 sites

  • Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease

    Ann Arbor, Michigan, 48109-0378

  • Piedmont Hospital; Transplant Services

    Atlanta, Georgia, 30309

  • EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center

    Atlanta, Georgia, 30322

  • Medical College of Georgia; Medicine/ Nephrology

    Augusta, Georgia, 30912

  • University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan

    Aurora, Colorado, 80045

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

  • Uni of Alabama At Birmingham; Division of Nephrology

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham; Pediatric Nephrology

    Birmingham, Alabama, 35233

  • Brigham & Women'S Hospital

    Boston, Massachusetts, 02115

  • Providence Clinical Research

    Burbank, California, 91505

  • Our Lady of Lourdes Medical Center; Transplant Dept

    Camden, New Jersey, 08103

  • Medical University of South Carolina; Pediatric Cardiology

    Charleston, South Carolina, 29425

  • DJL Clinical Research PLLC

    Charlotte, North Carolina, 28210

  • Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine

    Chicago, Illinois, 60611

  • Rush Uni Medical Center; Medicine/ Section of Infectious Diseases

    Chicago, Illinois, 60612

  • University of Chicago; Infectious Disease

    Chicago, Illinois, 60655

  • Uni of Cincinnati Medical Center; Nephrology & Hypertension

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Foundation; Infectious Disease

    Cleveland, Ohio, 44195

  • Children'S Medical Center of Dallas

    Dallas, Texas, 75235

  • Baylor University Medical Center Transplant Administration

    Dallas, Texas, 75246

  • UT Southwestern Medical Center; Pediatrics Dept.

    Dallas, Texas, 75390

  • Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation

    Dallas, Texas, TX 75246

  • Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building

    Detroit, Michigan, 48201

  • Henry Ford Health System; Gastroenterology

    Detroit, Michigan, 48202-2689

  • Wayne State University School of Medicine

    Detroit, Michigan, 48210

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • The Methodist Hospital

    Houston, Texas, 77005

  • M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health

    Houston, Texas, 77030

  • Beals Institute PC

    Lansing, Michigan, 48917

  • AIDS Research Alliance

    Los Angeles, California, 90015

  • UCLA Medical center Medicine/Nephrology

    Los Angeles, California, 90095

  • Texas Tech University Health Sciences Center; Department of Urology

    Lubbock, Texas, 79430

  • Novant Health Pulmonary and Critical Care

    Matthews, North Carolina, 28105

  • Long Island Jewish/North Shore Hospital

    New Hyde Park, New York, 11042

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • Mount Sinai Medical Center; Division of Liver Diseases

    New York, New York, 10029

  • Christiana Care Health System

    Newark, Delaware, 19713

  • Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112-4481

  • Omega Research Consultants

    Orlando, Florida, 32810

  • Drexel University; College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Uni of Pennsylvania; Infectious Diseases

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Children'S Hospital of Pittsburgh; Infectious Disease

    Pittsburgh, Pennsylvania, 15213

  • Duke University Health Systems

    Raleigh, North Carolina, 27609

  • University of California Davis Health System

    Sacramento, California, 95817

  • University of Utah Health Science Center Gastroenterology

    Salt Lake City, Utah, 84132

  • University of Texas Health Science Center Transplant center

    San Antonio, Texas, 78229

  • CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi

    San Francisco, California, 94115

  • Kendall South Medical Center Inc.

    South Miami, Florida, 33143

  • Western New England Renal & Transplant Associates, P.C.

    Springfield, Massachusetts, 01107

  • Washington University; Wash Uni. Sch. Of Med

    St Louis, Missouri, 63110

  • All Children'S Hospital; Pediatric Blood & Marrow Transplant Program

    St. Petersburg, Florida, 33701

  • Vita Research Solutions, Inc

    Tamarac, Florida, 33319

  • University of South Florida

    Tampa, Florida, 33612

  • Scott and White Division of Nephrology Dept of Medicine

    Temple, Texas, 76508

  • Toledo Hospital

    Toledo, Ohio, 43606

  • New England Research Associates

    Trumbull, Connecticut, 06611

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

South Africa17 sites

  • Josha Research

    Bloemfontein, 9301

  • Londisizwe Research Centre

    Durban, 4001

  • Sebastian Peter

    Durban, 4001

  • Dr V Naidoo Private Practice

    Durban, 4092

  • Govind U

    Durban, 4096

  • Soweto CTC - Dr Phoshoko site

    Johannesburg, 1818

  • Soweto CTC - Dr Mushwana site

    Johannesburg, 1983

  • Newtown Clinical Research

    Johannesburg, 2113

  • Mzansi Ethical Research Centre

    Middelburg, 1055

  • Be Part Yoluntu Centre

    Paarl, 7626

  • Global Clinical Trials Port Elizabeth

    Port Elizabeth, 6020

  • Kalafong Hospital; Pathology

    Pretoria, 0002

  • Emmed Research

    Pretoria, 0084

  • Synexus Clinical Research Centres SA Stanza Bopape

    Pretoria, 0112

  • Soweto Clinical Trial Centre

    Soweto, 1818

  • Tygerberg Hospital Pediatrics and Child Health

    Tygerberg; Cape Town, 7505

  • Welkom Clinical Trial Centre

    Welkom, 9460

Other trials in South Africa

Spain13 sites

  • Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas

    Barcelona, 08035

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036

  • Hospital Universitari de Bellvitge; Servicio de Nefrologia

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009

  • Hospital Clinico San Carlos; Servicio de Nefrologia

    Madrid, 28040

  • Hospital Universitario Clínico San Carlos; Servicio de Enfermedades Infecciosas

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; HIV Unit

    Madrid, 28041

  • Hospital Universitario 12 de Octubre; Servicio de Pediatria

    Madrid, 28041

  • Hospital Universitario La Paz; Hepatología y Trasplantes

    Madrid, 28046

  • Hospital Universitario la Paz; Servicio de Enfermedades Infecciosas - HIV unit

    Madrid, 28046

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, LA Coruña, 15706

Other trials in Spain

Hungary10 sites

  • Fov.Onk.Egyesitett Szt. Istvan es Szt Laszlo Korh.-Rend.Int.

    Budapest, 1096

  • Debreceni Egyetem, Orvos- és Egészségtudományi Centrum;

    Debrecen, 4032

  • Petz Aladar Megyei Korhaz; Hematologia

    Győr, 9024

  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

    Gyula, 5700

  • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

    Gyula, 5703

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • University of Szeged; Transplantation Department

    Szeged, 6720

  • Fejer Megyei Szent Gyorgy Korhaz

    Székesfehérvár, 8000

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

    Szolnok, 5000

  • Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

    Veszprém, 8200

Other trials in Hungary

Poland10 sites

  • Wojewodzki Szp.Specjalistyczny im.K.Dluskiego w Bialymstoku

    Bialystok, 15-540

  • NZOZ Vitamed

    Bydgoszcz, 85-079

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • SPZOZ Szpital Uniw W Krakowie

    Krakow, 31-501

  • SPZOZ Uniwersytecki Szp Klin; nr1 im.N.Barlickiego UM

    Lodz, 90-153

  • SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

    Szczecin, 70-111

  • Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology

    Warsaw, 02-006

  • Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

    Warsaw, 04-730

  • SP Szpital Kliniczny Nr 1 we Wroclawiu

    Wroclaw, 50-367

  • ALL-MED Specjalistyczna Opieka Medyczna

    Wroclaw, 50-445

Other trials in Poland

Germany8 sites

  • Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie

    Aachen, 52057

  • Charite - Campus Virchow Klinikum; Abteilung fuer Chirurgie

    Berlin, 13353

  • Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

    Essen, 45122

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • UNI-Klinikum Heidelberg Chirurgische Klinik

    Heidelberg, 69120

  • Ludwig-Maximilian-Universitaetsklinik; Med. Poliklinik/Infektiologie

    München, 80336

  • Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV

    München, 80336

  • Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie

    Münster, 48149

Other trials in Germany

Israel8 sites

  • Rambam Health Care Campus; Hematology

    Haifa, 31096

  • Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept.

    Jerusalem, 91120

  • Rabin MC- Belinson campus

    Petah Tikva, 49100

  • Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation

    Petah Tikva, 49100

  • Rabin Medical Center; Liver Inst.

    Petah Tikva, 49100

  • Chaim Sheba Medical Center; Hematology BMT & CBB

    Ramat Gan, 52662

  • Sourasky MC; Transplant Unit

    Tel Aviv, 64239

  • Chaim Sheba MC; Pediatric Hematology Oncology

    Tel HaShomer, 52621

Other trials in Israel

Czechia7 sites

  • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

    Brno, 625 00

  • Fakultni Nemocnice; Hemato-Oncology

    Pilsen, 300 00

  • The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf

    Prague, 12820

  • Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF

    Prague, 150 06

  • KASMED, s.r.o.; Alergologie a klinicka imunologie

    Tábor, 390 01

  • Revmatologicka Ambulance-Terezin

    Terezín, 411 55

  • Revmatologicka ambulance

    Zlín, 760 01

Other trials in Czechia

Italy7 sites

  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive

    Brescia, Lombardy, 25126

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi

    Milano, Molise, 20122

  • ASST DI MONZA; Divisione Malattie Infettive

    Monza, Lombardy, 20052

  • Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali

    Parma, Emilia-Romagna, 43100

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100

  • POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo

    Rome, Lazio, 00168

  • I.N.M.I. L. Spallanzani IRCCS

    Rome, Lazio, RM 00149

Other trials in Italy

Mexico7 sites

  • Phylaxis Clinical Research S de RL de CV

    Cuautitlán Izcalli, 54769

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; Infectología piso 7

    Guadalajara, 44280

  • Centro de Investigacion Clínica GRAMEL S.C

    México, 03720

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia

    México, 14000

  • INER- Instituto Nacional de Enfermedades Respiratorias"Ismae

    México, 14080

  • Hospital Universitario de Monterrey; Infectologia

    Monterrey, 64040

  • Hospital de Especialidades del Centro Medico Puerta de Hierr

    Zapopan, 45116

Other trials in Mexico

Argentina6 sites

  • Hospital General de Agudos Juan Antonio Fernandez; infectología

    Buenos Aires, 1202

  • Instituto Medico Platense

    Buenos Aires

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma Buenos Aires, 1426

  • Hospital General de Agudos Dr. Ignacio Pirovano

    Ciudad Autonoma Buenos Aires, 1430

  • Hospital Italiano de La Plata

    La Plata, 1725

  • Hospital de Niños Dr. Orlando Alassia

    Santa Fe, S3000CII

Other trials in Argentina

France6 sites

  • Centre Hospitalier de la Croix Rousse

    Lyon, 69317

  • Hopital Robert Debre; Pediatric Hematology Dept

    Paris, 75019

  • Hopital Saint Louis; Service de Nephrologie - Transplantation

    Paris, 75475

  • Hopital Europeen Georges Pompidou; Service de Nephrologie

    Paris, 75908

  • Hopital Rangueil; Nephrologie

    Toulouse, 31059

  • CHRU Bretonneau

    Tours, 37044

Other trials in France

Lithuania6 sites

  • Kaunas Clinics Public Institution; Clinic of Nephrology

    Kaunas, 50009

  • Klaipeda University Hospital; Public Institution

    Klaipėda, 92288

  • Siauliai Republican Hospital Public Institution

    Šiauliai, 76231

  • Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center

    Vilnius, 08661

  • Vilnius University Hospital Santariskiu Clinic

    Vilnius, 08661

  • Republican Tuberculosis and Infectious Diseases University H

    Vilnius, 8117

Other trials in Lithuania

Brazil5 sites

  • Fiocruz - Fundação Oswaldo Cruz

    Rio de Janeiro, Rio de Janeiro, 21040-360

  • Hospital Alemao Oswaldo Cruz; Oncologia

    São Paulo, São Paulo, 01323-020

  • Iop - Graacc - Unifesp

    São Paulo, São Paulo, 04023-062

  • Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

    São Paulo, São Paulo, 04038-002

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Estonia5 sites

  • West Tallinn Central Hospital; Nephrology

    Tallinn, 10617

  • North Estonia medical Centre; Hematology

    Tallinn, 13419

  • Tartu Uni Clinics; Clinic of Surgery & Internal Medicine Dept of Nephrology

    Tartu, 51014

  • Tartu Uni Hospital; Hematology - Oncology Clinic

    Tartu, 51014

  • Tartu University Hospital; Department of Infectious Diseases

    Tartu, 51014

Other trials in Estonia

Guatemala5 sites

  • Clinica Familiar Luis Angel Garcia

    Guatemala City, 01001

  • CERICAP

    Guatemala City, 01009

  • Centro de Investigaciones Pediatricas

    Guatemala City, 1015

  • Hospital Roosevelt Guatemala; Clinica de Infecciosas

    Guatemala City

  • Unidad Nacional de Oncologia Pediatrica

    Guatemala City

Other trials in Guatemala

Belgium4 sites

  • Onze Lieve Vrouwziekenhuis Aalst

    Aalst, 9300

  • Institut Jules Bordet

    Brussels, 1000

  • Hospital Erasme; Neurologie

    Brussels, 1070

  • UZ Brussel

    Brussels, 1090

Other trials in Belgium

Bulgaria4 sites

  • UMHA - Sv. Georgi; Clinic of Nephrology & Haemodialysis

    Plovdiv, 4002

  • UMHAT Sv. Georgi, EAD; Clinic of Infectious Diseases

    Plovdiv, 4002

  • Mhat Alexandrovska Ead ; Clinic of Nephrology & Transplantation, Uni Hospital

    Sofia, 1431

  • Specialized Hospital for children with oncohaematologica Diseases; Dept. Of Transplantations

    Sofia, 1527

Other trials in Bulgaria

Colombia4 sites

  • Infectologos Asociados

    Barranquilla

  • Simedics Ips

    Bogotá

  • Centro de Investigaciones Clinicas S.A.S

    Cali

  • Fundacion Cardiovascular de Colombia - Instituto del Corazón

    Floridablanca

Other trials in Colombia

Ukraine4 sites

  • Ukrainian Pediatric Specialized Hospital of Ministry of Health of Ukraine Dept of BMT

    Kiev, 01135

  • Institute of Nephrology AMS; Dept of Nephrology & dialysis

    Kiev, 04050

  • Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed

    Lugnansk, 91045

  • Zaporozhye State Medical University; Dept of Transplantology

    Zaporizhzhya, 69600

Other trials in Ukraine

Chile3 sites

  • Hospital Luis Calvo Mackenna; Unidad de Investigacion

    Santiago, 7500539

  • Hospital Dr. Sotero del Rio

    Santiago, 8207257

  • Centro de Investigaciones Clinicas Viña del Mar

    Viña Del Mar Valparaiso, 2520000

Other trials in Chile

United Kingdom3 sites

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS2 8BJ

  • Manchester Royal Infirmary; Renal Transplant Unit

    Manchester, M13 9WL

  • Nottingham City Hospital; Transplant Unit

    Nottingham, NG5 1PB

Other trials in United Kingdom

Canada2 sites

  • St Paul'S

    Saskatoon, Saskatchewan, S7M 0Z9

  • Uni of Manitoba; Faculty of Medicine

    Winnipeg, Manitoba, R3E 6518

Other trials in Canada

Latvia2 sites

  • Latvia Transplantation Center P. Stradina Hospital; Transplantation

    Riga, LV-1002

  • Children's Clinical University Hospital

    Riga, LV-1004

Other trials in Latvia

Romania1 site

  • Institutul de Urologie Si Transplant Renal Fundeni

    Bucharest, 022328

Other trials in Romania

Switzerland1 site

  • Universitätsspital Zürich; Klinik für Nephrologie

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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.

Being tested
oseltamivir, placebo
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oseltamivirDrug

    Also called Tamiflu

    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

  • placeboOther

    Placebo matched to oseltamivir po twice daily for 10 days

Study groups in NCT00545532
Study groupRoleWhat they receive
Conventional doseExperimentalImmunocompromised 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.
Receives: Drug: oseltamivir; Other: placebo
Double doseExperimentalImmunocompromised 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.
Receives: Drug: oseltamivir; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Baseline up to Day 40

  2. Percentage of Participants Who Developed Viral Resistance to Oseltamivir

    Resistance was defined as the presence of oseltamivir resistance mutations in viruses isolated from nasopharyngeal swab samples, identified by sequencing of the neuraminidase (NA) and hemagglutinin (HA) genes (genotypic resistance) and/or determination of the oseltamivir concentration at which the response is reduced by half (IC50) in an NA inhibition assay (phenotypic resistance). Reported are post-baseline phenotypic and genotypic resistance in adults >/= 18 years and children and adolescents <18 years in the modified Intent-to-Treat infected (mITTi) population.

    Measured: Baseline up to Day 40

  3. Percentage of Participants With Tissue Rejection or Graft Versus Host Disease (GVHD)

    The percentage of transplant patients in the safety population who experienced tissue rejection and/or GvHD is reported.

    Measured: Baseline up to Day 40

Secondary outcomes (42)

  1. Time to Resolution (TTR) of All Clinical Influenza Symptoms

    TTR of all clinical influenza symptoms was defined as the time from treatment initiation to the start of the 24-hour period in which all 7 influenza symptoms had scores </= 1 (mild) and remained </=1 for at least 21.5 hours. . Reported are TTRs in adults >/= 18 years, adults and adolescents >/= 13 years and children <13 years in the mITTi population.

    Measured: Baseline up to Day 40

  2. Total Symptom Score Area Under the Efficacy Curve (AUE)

    The overall extent and severity of illness was quantified by the AUE of the total symptom scores over the duration of illness, i.e., from the start of treatment to the time symptoms first alleviated. Total symptom scores were calculated from the sum of seven individual symptom scores with each individual symptom scored from 0 (healthy) to 3 (worst sickness) and a maximum total symptom score of 21. The AUE of these average scores was then calculated for each participant using the trapezoidal rule (the trapezoidal rule calculates the area under any curve by adding up all trapezoids under such a curve). A larger area indicates more severe disease. In this study participants were treated for 10 days. If a participant had scored 21 on every visit then AUE would have been 21 score x 10 days x 24 hours/day =5040 score x hours units, which is the highest possible score. The lowest possible score is 0. Reported are results for adults >/= 18 years in the mITTi population.

    Measured: Baseline up to Day 40

  3. Time to Resolution of Fever

    Fever was defined as temperature >/= 37.8 degrees Celsius at any time point during the study. TTR of fever was determined in Adults >/= 18 years, Adults and adolescents >/= 13 years and Children < 13 years of the mITTi population.

    Measured: Baseline up to Day 40

  4. Change From Baseline in Viral Load Assessed by Culture

    Nasopharyngeal swab samples were cultured in Madin-Darby Canine Kidney cells. Culture supernatants were harvested after 2 weeks, or after a full-blown cytopathic effect was observed. Presence of infectious viruses in the cell culture supernatants (viral titer), expressed as log10 50% Tissue Culture Infectious Dose/milliliter (TCID50/mL), was determined by hemagglutination assay using turkey erythrocytes for H1 and B viruses or by detection of the virus nucleoprotein (NP) using ELISA for H3 viruses. A value of < 0.5 log10 TCID50/mL was interpreted as negative. Data are reported for adults >/= 18 years and adolescents and children < 18 years.

    Measured: 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.

  5. Percentage of Participants With Viral Shedding Assessed by Culture Over Time

    Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the percentage of participants with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.

    Measured: 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.

  6. Time to Cessation of Viral Shedding by Cell Culture

    Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.

    Measured: Baseline up to Day 40

  7. Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)

    Nasopharyngeal swab samples were tested for influenza A and B RNA using semi-quantitative RT-PCR specific for influenza A and B matrix gene, respectively, after viral RNA isolation. Cycle threshold (Ct) value was determined for each sample. Conversion of Ct values into viral load, expressed as log10 virus particles/mL (vp/mL), was obtained using external standard curves ran in parallel in all RT-PCR experiments. A value of < 2.6 log10 vp/mL for Flu A strains and < 3.0 log10 vp/mL for Flu B strains was interpreted as a negative result. Data are reported for adults >/= 18 years and adolescents and children < 18 years.

    Measured: 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.

  8. Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time

    Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the percentage of subjects with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.

    Measured: 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.

  9. Time to Cessation of Viral Shedding by RT-PCR

    Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.

    Measured: Baseline up to Day 40

  10. Percentage of Participants With Persistent Viral Shedding

    Persistent shedding was defined as a viral load reduction <1 log10 vp/mL at end of treatment compared with baseline. Reported is the percentage of participants with persistent viral shedding at end of treatment in adults >/= 18 years and adolescents and children < 18 years.

    Measured: Baseline to Day 11 (EOT)

  11. Percentage of Participants Who Developed Secondary Illness

    Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with at least one event in adults >/= 18 years and adolescents and children < 18 years.

    Measured: Baseline up to Day 40

  12. Percentage of Participants Who Initiated Antibiotic Treatment

    Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with secondary illness, who initiated antibiotic treatment, in adults >/= 18 years and adolescents and children < 18 years.

    Measured: Baseline up to Day 40

  13. Percentage of Participants Hospitalized

    Reported is the percentage of participants, who required hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.

    Measured: Baseline up to Day 40

  14. Duration of Hospitalization

    Reported is the duration of hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.

    Measured: Baseline up to Day 40

  15. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults

    Reported here are oseltamivir Cmax data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  16. Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults

    Reported here are oseltamivir Ctrough data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  17. Pharmacokinetics : Area Under the Concentration-Time Curve From 0 to 12 Hours (AUC0-12) at Steady State of Oseltamivir in Adults

    AUC0-12 was reported at steady state as nanograms per hour per milliliter. (ng*hr/mL). Reported here are oseltamivir AUC0-12 data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose

  18. Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults

    Reported here are oseltamivir tmax data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  19. Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults

    Reported here are oseltamivir ke data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  20. Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults

    Reported here are oseltamivir CL/F data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  21. Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults

    Reported here are oseltamivir Vc/F data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  22. Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults

    Reported here are oseltamivir carboxylate Cmax data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  23. Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults

    Reported here are oseltamivir carboxylate Ctrough data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  24. Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults

    Reported here are oseltamivir carboxylate AUC0-12 data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  25. Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults

    Reported here are oseltamivir carboxylate tmax data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  26. Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults

    Reported here are oxeltamivir carboxylate ke data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  27. Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults

    Reported here are oseltamivir carboxylate CL/F data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  28. Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults

    Reported here are oseltamivir carboxylate Vc/F data for adults >/= 18 years.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  29. Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children

    Reported here are oseltamivir Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  30. Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children

    Reported here are oseltamivir Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  31. Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children

    AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose

  32. Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children

    Reported here are oseltamivir data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  33. Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children

    Reported here are oseltamivir carboxylate Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  34. Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children

    Reported here are oseltamivir carboxylate Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  35. Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children

    AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir carboxylate AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose

  36. Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children

    Reported here are oseltamivir carboxylate tmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  37. Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children

    Reported here are oseltamivir ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  38. Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children

    Reported here are oseltamivir CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  39. Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children

    Reported here are oseltamivir Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  40. Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children

    Reported here are oseltamivir carboxylate ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  41. Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children

    Reported here are oseltamivir carboxylate CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

  42. Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children

    Reported here are oseltamivir carboxylate Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

    Measured: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2007 (estimated)
  2. Study start4 Feb 2008
  3. Primary completion2 May 2017
  4. Study completion2 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00545532
Sponsor's protocol ID
NV20234
Other IDs
2006-002468-24
Status last verified
Jun 2018
First submitted
16 Oct 2007
Last updated
12 Jul 2018
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 31667696

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing oseltamivir in people with Influenza, Human, run by Hoffmann-La Roche at 208 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 208 sites in United States, South Africa, Spain, Hungary, Poland and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (time frame: Baseline up to Day 40). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00545532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.

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