Influenza, Human Clinical Trial
Official title:
A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza
Verified date | June 2018 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 228 |
Est. completion date | May 2, 2017 |
Est. primary completion date | May 2, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital General de Agudos Juan Antonio Fernandez; infectología | Buenos Aires | |
Argentina | Instituto Medico Platense | Buenos Aires | |
Argentina | Hospital General de Agudos Dr. Ignacio Pirovano | Ciudad Autonoma Buenos Aires | |
Argentina | Instituto Medico Especializado Alexander Fleming | Ciudad Autonoma Buenos Aires | |
Argentina | Hospital Italiano de La Plata | La Plata | |
Argentina | Hospital de Niños Dr. Orlando Alassia | Santa Fe | |
Belgium | Onze Lieve Vrouwziekenhuis Aalst | Aalst | |
Belgium | UZ Brussel | Brussel | |
Belgium | Hospital Erasme; Neurologie | Bruxelles | |
Belgium | Institut Jules Bordet | Bruxelles | |
Brazil | Fiocruz - Fundação Oswaldo Cruz | Rio de Janeiro | RJ |
Brazil | Hospital Alemao Oswaldo Cruz; Oncologia | Sao Paulo | SP |
Brazil | Hospital das Clinicas - FMUSP | Sao Paulo | SP |
Brazil | Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos | Sao Paulo | SP |
Brazil | Iop - Graacc - Unifesp | Sao Paulo | SP |
Bulgaria | 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 | |
Canada | St Paul'S | Saskatoon | Saskatchewan |
Canada | Uni of Manitoba; Faculty of Medicine | Winnipeg | Manitoba |
Chile | Hospital Dr. Sotero del Rio | Santiago | |
Chile | Hospital Luis Calvo Mackenna; Unidad de Investigacion | Santiago | |
Chile | Centro de Investigaciones Clinicas Viña del Mar | Viña Del Mar Valparaiso | |
Colombia | Infectologos Asociados | Barranquilla | |
Colombia | Simedics Ips | Bogota | |
Colombia | Centro de Investigaciones Clinicas S.A.S | Cali | |
Colombia | Fundacion Cardiovascular de Colombia - Instituto del Corazón | Floridablanca | |
Czechia | Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika | Brno | |
Czechia | Fakultni Nemocnice; Hemato-Oncology | Plzen | |
Czechia | The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf | Praha | |
Czechia | Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF | Praha 5 | |
Czechia | KASMED, s.r.o.; Alergologie a klinicka imunologie | Tabor | |
Czechia | Revmatologicka Ambulance-Terezin | Terezin | |
Czechia | Revmatologicka ambulance | Zlin | |
Estonia | North Estonia medical Centre; Hematology | Tallinn | |
Estonia | West Tallinn Central Hospital; Nephrology | 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 | |
France | Centre Hospitalier de la Croix Rousse | Lyon | |
France | Hopital Europeen Georges Pompidou; Service de Nephrologie | Paris | |
France | Hopital Robert Debre; Pediatric Hematology Dept | Paris | |
France | Hopital Saint Louis; Service de Nephrologie - Transplantation | Paris | |
France | Hopital Rangueil; Nephrologie | Toulouse | |
France | CHRU Bretonneau | Tours | |
Germany | 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 | Muenchen | |
Germany | Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV | Muenchen | |
Germany | Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie | Muenster | |
Guatemala | CERICAP | Ciudad de Guatemala | |
Guatemala | Clinica Familiar Luis Angel Garcia | Ciudad de Guatemala | |
Guatemala | Unidad Nacional de Oncologia Pediatrica | Guatemala | |
Guatemala | Centro de Investigaciones Pediatricas | Guatemala City | |
Guatemala | Hospital Roosevelt Guatemala; Clinica de Infecciosas | Guatemala City | |
Hungary | 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 | Gyor | |
Hungary | Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza | Gyula | |
Hungary | Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek | Gyula | |
Hungary | Pecsi Tudomanyegyetem | Pecs | |
Hungary | University of Szeged; Transplantation Department | Szeged | |
Hungary | Fejer Megyei Szent Gyorgy Korhaz | Szekesfehervar | |
Hungary | Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int. | Szolnok | |
Hungary | Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt. | Veszprem | |
Israel | Rambam Health Care Campus; Hematology | Haifa | |
Israel | Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept. | Jerusalem | |
Israel | Rabin MC- Belinson campus | Petach Tikva | |
Israel | Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation | Petach Tikva | |
Israel | Rabin Medical Center; Liver Inst. | Petach 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 Hashomer | |
Italy | ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive | Brescia | Lombardia |
Italy | Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi | Milano | Molise |
Italy | ASST DI MONZA; Divisione Malattie Infettive | Monza | Lombardia |
Italy | Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali | Parma | Emilia-Romagna |
Italy | Fondazione IRCCS Policlinico San Matteo | Pavia | Lombardia |
Italy | I.N.M.I. L. Spallanzani IRCCS | Roma | Lazio |
Italy | POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo | Roma | Lazio |
Latvia | Children`s Clinical University Hospital | Riga | |
Latvia | Latvia Transplantation Center P. Stradina Hospital; Transplantation | Riga | |
Lithuania | Kaunas Clinics Public Institution; Clinic of Nephrology | Kaunas | |
Lithuania | Klaipeda University Hospital; Public Institution | Klaipeda | |
Lithuania | Siauliai Republican Hospital Public Institution | Siauliai | |
Lithuania | Republican Tuberculosis and Infectious Diseases University H | Vilnius | |
Lithuania | Vilnius University Hospital Santariskiu Clinic | Vilnius | |
Lithuania | Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center | Vilnius | |
Mexico | Phylaxis Clinical Research S de RL de CV | Cuautitlan Izcalli | |
Mexico | Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; Infectología piso 7 | Guadalajara | |
Mexico | Centro de Investigacion Clínica GRAMEL S.C | Mexico | |
Mexico | INER- Instituto Nacional de Enfermedades Respiratorias"Ismae | Mexico | |
Mexico | Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia | Mexico | |
Mexico | Hospital Universitario de Monterrey; Infectologia | Monterrey | |
Mexico | Hospital de Especialidades del Centro Medico Puerta de Hierr | Zapopan | |
Poland | 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 | Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego | Warszawa | |
Poland | Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology | Warszawa | |
Poland | ALL-MED Specjalistyczna Opieka Medyczna | Wroclaw | |
Poland | SP Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw | |
Romania | Institutul de Urologie Si Transplant Renal Fundeni | Bucharest | |
South Africa | Josha Research | Bloemfontein | |
South Africa | Dr V Naidoo Private Practice | Durban | |
South Africa | Govind U | Durban | |
South Africa | Londisizwe Research Centre | Durban | |
South Africa | Sebastian Peter | Durban | |
South Africa | Newtown Clinical Research | Johannesburg | |
South Africa | Soweto CTC - Dr Mushwana site | Johannesburg | |
South Africa | Soweto CTC - Dr Phoshoko site | 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 | Emmed Research | Pretoria | |
South Africa | Kalafong Hospital; Pathology | 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 | |
Spain | Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas | Barcelona | |
Spain | Hospital Universitari de Bellvitge; Servicio de Nefrologia | Hospitalet de Llobregat | Barcelona |
Spain | Hospital Clinico San Carlos; Servicio de Nefrologia | Madrid | |
Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
Spain | Hospital Infantil Universitario Nino Jesus | Madrid | |
Spain | Hospital Universitario 12 de Octubre; HIV Unit | Madrid | |
Spain | Hospital Universitario 12 de Octubre; Servicio de Pediatria | Madrid | |
Spain | Hospital Universitario Clínico San Carlos; Servicio de Enfermedades Infecciosas | Madrid | |
Spain | Hospital Universitario La Paz; Hepatología y Trasplantes | Madrid | |
Spain | Hospital Universitario la Paz; Servicio de Enfermedades Infecciosas - HIV unit | Madrid | |
Spain | Hospital Clinico Universitario de Santiago | Santiago de Compostela | LA Coruña |
Switzerland | Universitätsspital Zürich; Klinik für Nephrologie | Zürich | |
Ukraine | Institute of Nephrology AMS; Dept of Nephrology & dialysis | Kiev | |
Ukraine | Ukrainian Pediatric Specialized Hospital of Ministry of Health of Ukraine Dept of BMT | Kiev | |
Ukraine | Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed | Lugnansk | |
Ukraine | Zaporozhye State Medical University; Dept of Transplantology | Zaporozhye | |
United Kingdom | 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 States | Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease | Ann Arbor | Michigan |
United States | EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center | Atlanta | Georgia |
United States | Piedmont Hospital; Transplant Services | Atlanta | Georgia |
United States | Medical College of Georgia; Medicine/ Nephrology | Augusta | Georgia |
United States | University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan | Aurora | Colorado |
United States | University of Maryland School of Medicine | Baltimore | Maryland |
United States | Pacific Oaks Medical Group | Beverly Hills | California |
United States | Uni of Alabama At Birmingham; Division of Nephrology | Birmingham | Alabama |
United States | University of Alabama at Birmingham; Pediatric Nephrology | Birmingham | Alabama |
United States | Brigham & Women'S Hospital | Boston | Massachusetts |
United States | Providence Clinical Research | Burbank | California |
United States | Our Lady of Lourdes Medical Center; Transplant Dept | Camden | New Jersey |
United States | Medical University of South Carolina; Pediatric Cardiology | Charleston | South Carolina |
United States | DJL Clinical Research PLLC | Charlotte | North Carolina |
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 | Uni of Cincinnati Medical Center; Nephrology & Hypertension | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation; Infectious Disease | Cleveland | Ohio |
United States | Baylor University Medical Center Transplant Administration | Dallas | Texas |
United States | Children'S Medical Center of Dallas | Dallas | Texas |
United States | Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation | Dallas | Texas |
United States | UT Southwestern Medical Center; Pediatrics Dept. | Dallas | Texas |
United States | Henry Ford Health System; Gastroenterology | Detroit | Michigan |
United States | Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building | Detroit | Michigan |
United States | Wayne State University School of Medicine | Detroit | Michigan |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health | Houston | Texas |
United States | The Methodist Hospital | Houston | Texas |
United States | Beals Institute PC | Lansing | Michigan |
United States | AIDS Research Alliance | Los Angeles | California |
United States | UCLA Medical center Medicine/Nephrology | Los Angeles | California |
United States | Texas Tech University Health Sciences Center; Department of Urology | Lubbock | Texas |
United States | Novant Health Pulmonary and Critical Care | Matthews | North Carolina |
United States | Long Island Jewish/North Shore Hospital | New Hyde Park | New York |
United States | Tulane University Medical Center | New Orleans | Louisiana |
United States | Mount Sinai Medical Center; Division of Liver Diseases | New York | New York |
United States | Christiana Care Health System | Newark | Delaware |
United States | Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center | Oklahoma City | Oklahoma |
United States | Omega Research Consultants | Orlando | Florida |
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 | Duke University Health Systems | Raleigh | North Carolina |
United States | University of California Davis Health System | Sacramento | California |
United States | Washington University; Wash Uni. Sch. Of Med | Saint Louis | Missouri |
United States | All Children'S Hospital; Pediatric Blood & Marrow Transplant Program | Saint Petersburg | Florida |
United States | University of Utah Health Science Center Gastroenterology | Salt Lake City | Utah |
United States | University of Texas Health Science Center Transplant center | San Antonio | Texas |
United States | CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi | San Francisco | California |
United States | Kendall South Medical Center Inc. | South Miami | Florida |
United States | Western New England Renal & Transplant Associates, P.C. | Springfield | Massachusetts |
United States | Vita Research Solutions, Inc | Tamarac | Florida |
United States | University of South Florida | Tampa | Florida |
United States | Scott and White Division of Nephrology Dept of Medicine | Temple | Texas |
United States | Toledo Hospital | Toledo | Ohio |
United States | New England Research Associates | Trumbull | Connecticut |
United States | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, France, Germany, Guatemala, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Poland, Romania, South Africa, Spain, Switzerland, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline up to Day 40 | |
Primary | 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. | Baseline up to Day 40 | |
Primary | 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. | Baseline up to Day 40 | |
Secondary | 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 | Baseline up to Day 40 | |
Secondary | 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. | Baseline up to Day 40 | |
Secondary | 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. | Baseline up to Day 40 | |
Secondary | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. | Baseline up to Day 40 | |
Secondary | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. | Baseline up to Day 40 | |
Secondary | 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. | Baseline to Day 11 (EOT) | |
Secondary | 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. | Baseline up to Day 40 | |
Secondary | 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. | Baseline up to Day 40 | |
Secondary | 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. | Baseline up to Day 40 | |
Secondary | 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. | Baseline up to Day 40 | |
Secondary | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults | Reported here are oseltamivir Cmax data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults | Reported here are oseltamivir Ctrough data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults | Reported here are oseltamivir tmax data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults | Reported here are oseltamivir ke data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults | Reported here are oseltamivir CL/F data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults | Reported here are oseltamivir Vc/F data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults | Reported here are oseltamivir carboxylate Cmax data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults | Reported here are oseltamivir carboxylate Ctrough data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults | Reported here are oseltamivir carboxylate AUC0-12 data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults | Reported here are oseltamivir carboxylate tmax data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults | Reported here are oxeltamivir carboxylate ke data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults | Reported here are oseltamivir carboxylate CL/F data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults | Reported here are oseltamivir carboxylate Vc/F data for adults >/= 18 years. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose | |
Secondary | 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. | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
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