A Study to Explore the Incidence of Influenza and Respiratory Syncytial Virus (RSV) in Adults Hospitalized With Acute Respiratory Tract Infection

Last updated: May 9, 2017
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Treatment

N/A

Clinical Study ID

NCT03148405
CR108262
NOPRODRSV0006
  • Ages > 18
  • All Genders

Study Summary

The purpose of the main study is to describe the incidence of influenza virus and respiratory syncytial virus (RSV) in adults hospitalized with acute respiratory tract infection (ARTI) during the influenza/RSV season, and the purpose of the substudy is to describe the clinical and economic burden in adults hospitalized with confirmed influenza/RSV infection.

Eligibility Criteria

Inclusion

Inclusion Criteria: Main Study:

  • Participants (or their legally acceptable representative) who signed an informedconsent form

  • Hospitalized

  • Participants with clinical diagnosis of acute respiratory tract infection (ARTI)during the influenza/respiratory syncytial virus (RSV) season, with or withoutassociated complications or other diseases (such as, but not limited to: acuteexacerbation of asthma or chronic obstructive pulmonary disease [COPD], malignancy,hypoxemia, congestive heart failure, sepsis, septic shock, pregnancy,immunodeficiencies) Substudy:

  • Participants with confirmed diagnosis of influenza and/or RSV infection using aPCR-based influenza/RSV test

Exclusion

Exclusion Criteria: Main study and Substudy:

  • Participants who participated in another clinical study, with the exception ofregistry and epidemiology studies involving minimum sampling done prior to theparticipant screening for the proposed study

  • Participants not able to comply with study-related procedures, due to their mentalstatus or severe clinical condition, based on clinical judgement of the investigator

  • Participants who received an experimental RSV vaccine

Study Design

Total Participants: 5000
Study Start date:
January 25, 2017
Estimated Completion Date:
February 07, 2020

Connect with a study center

  • Instituto Medico Platense

    Buenos Aires, B1900AVG
    Argentina

    Site Not Available

  • Hospital Nuestra Señora de la Misericordia

    Cordoba, 5000
    Argentina

    Site Not Available

  • Hospital San Roque

    Córdoba, 5000
    Argentina

    Site Not Available

  • Hospital Zonal General de Agudos Heroes de Malvinas

    Merlo, B1722
    Argentina

    Site Not Available

  • Sanatorio Britanico S.A.

    Rosario, 2000
    Argentina

    Site Not Available

  • Hospital Felício Rocho

    Belo Horizonte, 30110-060
    Brazil

    Site Not Available

  • Infection Control Ltda

    Brasil, 30110-063
    Brazil

    Site Not Available

  • Botucatu Medical School, Sao Paulo State University

    São Paulo, 18.618-686
    Brazil

    Site Not Available

  • Iwk Health Centre

    Halifax, Nova Scotia B3k6r8
    Canada

    Suspended

  • Mount Sinai Hospital

    Toronto, M5G 1X5
    Canada

    Suspended

  • CHU Lyon Sud

    Lyon Cedex 03, 69437
    France

    Site Not Available

  • CHU de Montpellier, Hôpital Saint-Eloi

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Hopital Cochin

    Paris, 75014
    France

    Site Not Available

  • APHP - Hôpital Bichat - Claude Bernard

    Paris Cedex 18, 75877
    France

    Site Not Available

  • Chu Rennes - Hôpital Pontchaillou

    Rennes Cedex 09, 35033
    France

    Site Not Available

  • Klinikum Donaustauf

    Donaustauf, 93093
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen, Medizinische Klinik 3

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 160
    Germany

    Site Not Available

  • Korea University Ansan Hospital

    Ansan-Si, 425-707
    Korea, Republic of

    Active - Recruiting

  • The Catholic university of Korea, ST Vincent Hospital

    Gyeonggi-Do, 442-723
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Active - Recruiting

  • Yonsei University Wonju Severance Christian Hospital

    Korea, 26426
    Korea, Republic of

    Active - Recruiting

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 150-950
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul, 152-703
    Korea, Republic of

    Active - Recruiting

  • Hospital Miri

    Miri, Sarawak
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang

    Pulau Pinang, 10990
    Malaysia

    Site Not Available

  • Hospital Sungai Buloh

    Sungai Buloh, 47000
    Malaysia

    Site Not Available

  • Instituto Nacional de Enfermedades Respiratorias

    Mexico, 14080
    Mexico

    Site Not Available

  • Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias

    Monterrey, 64460
    Mexico

    Site Not Available

  • Hospital Metropilitano

    San Nicolas De Los Garza, 66480
    Mexico

    Site Not Available

  • Singapore General Hospital

    Singapore, 169608
    Singapore

    Suspended

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Suspended

  • Emmed Research

    Pretoria, 0002
    South Africa

    Site Not Available

  • Into Research

    Pretoria, 0181
    South Africa

    Site Not Available

  • Medical College of Georgia

    Augusta, Georgia 30912
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52246
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Rochester / Rochester General Hospital

    Rochester, New York 14621
    United States

    Active - Recruiting

  • clinical research of Gastonia

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Research Across America

    Dallas, Texas 75234
    United States

    Site Not Available

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