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

Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148405
• Other study ID #: CR108262
• Secondary ID: NOPRODRSV0006
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: May 9, 2017
• Start date: January 25, 2017
• Est. completion date: February 7, 2020

Study information

• Verified date: May 2017
• Source: Janssen Research & Development, LLC
• Contact: Study contact
• Phone: 844-434-4210
• Email: JNJ.CT[@]sylogent.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Main Study:

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

• Hospitalized

• Participants with clinical diagnosis of acute respiratory tract infection (ARTI) during the influenza/respiratory syncytial virus (RSV) season, with or without associated complications or other diseases (such as, but not limited to: acute exacerbation 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 a PCR-based influenza/RSV test

Exclusion Criteria:

Main study and Substudy:

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

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

• Participants who received an experimental RSV vaccine

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections

Locations

Country	Name	City	State
Argentina	Instituto Medico Platense	Buenos Aires
Argentina	Hospital Nuestra Señora de la Misericordia	Cordoba
Argentina	Hospital San Roque	Córdoba
Argentina	Hospital Zonal General de Agudos Heroes de Malvinas	Merlo
Argentina	Sanatorio Britanico S.A.	Rosario
Brazil	Hospital Felício Rocho	Belo Horizonte
Brazil	Infection Control Ltda	Brasil
Brazil	Botucatu Medical School, Sao Paulo State University	São Paulo
Canada	Iwk Health Centre	Halifax	Nova Scotia
Canada	Mount Sinai Hospital	Toronto
France	CHU Lyon Sud	Lyon Cedex 03
France	CHU de Montpellier, Hôpital Saint-Eloi	Montpellier Cedex 5
France	Hopital Cochin	Paris
France	APHP - Hôpital Bichat - Claude Bernard	Paris Cedex 18
France	Chu Rennes - Hôpital Pontchaillou	Rennes Cedex 09
Germany	Klinikum Donaustauf	Donaustauf
Germany	Universitätsklinikum Erlangen, Medizinische Klinik 3	Erlangen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Korea, Republic of	Korea University Ansan Hospital	Ansan-Si
Korea, Republic of	The Catholic university of Korea, ST Vincent Hospital	Gyeonggi-Do
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Korea
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Malaysia	Hospital Miri	Miri
Malaysia	Hospital Pulau Pinang	Pulau Pinang
Malaysia	Hospital Sungai Buloh	Sungai Buloh
Mexico	Instituto Nacional de Enfermedades Respiratorias	Mexico
Mexico	Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias	Monterrey
Mexico	Hospital Metropilitano	San Nicolas De Los Garza
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
South Africa	Emmed Research	Pretoria
South Africa	Into Research	Pretoria
United States	Medical College of Georgia	Augusta	Georgia
United States	Research Across America	Dallas	Texas
United States	clinical research of Gastonia	Gastonia	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of Rochester / Rochester General Hospital	Rochester	New York
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  France,  Germany,  Korea, Republic of,  Malaysia,  Mexico,  Singapore,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main Study: Incidence of Influenza Virus	Incidence of influenza virus will be determined by the number of participants with confirmed influenza(confirmed by quantitative reverse transcription [qRT]-polymerase chain recation [PCR]) among participants hospitalized with acute respiratory tract infection (ARTI).	Day 1
Primary	Main Study: Incidence of Respiratory Syncytial Virus (RSV)	Incidence of RSV will be determined by the number of participants with confirmed RSV (confirmed by qRT-PCR) among participants hospitalized with ARTI.	Day 1
Primary	Substudy: Clinical and Economic Burden in Adults Hospitalized With Confirmed Influenza or RSV	The Medical Resource Utilization (MRU) questionnaire will be used to determine the clinical and economic burden (the effect of the disease on the medical and economic system relative to the total respiratory infection-related burden) in hospitalized adults during the influenza/RSV season.	Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)
Primary	Substudy: Barthel Activities of Daily Living (ADL) Questionnaire	Barthel ADL Questionnaire is a 10-item questionnaire measuring performance in self-care activities of daily living. Sum of the participant's scores for each item will give total score. Total possible scores range from 0 to 20, with lower scores indicating increased disability.	Approximately up to 2 months post hospital discharge (approximate hospitalization duration: 7 days)
Primary	Substudy: Lawton Instrumental Activities of Daily Living (IADL) Questionnaire	Lawton IADL Questionnaire assess the participants' ability to perform daily tasks. The questionnaire measures 8 domains of functions required for independent living. 8 instrumental ADLs include managing finances, transportation, food preparation. The questionnaire scores the participant's highest functional level (either 0 or 1).	Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)
Primary	Substudy: Respiratory Intensity and Impact Questionnaire (RiiQ) Symptom Scale	RiiQ Symptom Scale is a symptom rating scale for respiratory infections and will document the intensity (none, mild, moderate, or severe) of respiratory infection symptoms experienced by the participant.	Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)
Primary	Substudy: Respiratory Symptoms Bother and Change in Health Status Questionnaire	The Respiratory Symptoms Bother and Change in Health Status Questionnaire is an impact rating scale for respiratory infections and will document the degree of bothersomeness of respiratory symptoms (mild, moderate, or severe) experienced by the participant.	Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)
Primary	Substudy: EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire	The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).	Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)
Secondary	Main Study: Incidence of the Different Types of Respiratory Pathogens (Other Than Influenza Virus and RSV)	Incidence will be determined by the number of participants with respiratory pathogens other than influenza and RSV. One nasal swab (mid turbinate) will be collected from all participants for the detection and identification of respiratory pathogens causing the ARTI.	Day 1
Secondary	Substudy: Viral Load in Nasal Swab Specimens in Adults Hospitalized With Confirmed Influenza/RSV Infection	The quantification of the influenza and RSV viral load in nasal swabs from participants with influenza or RSV infection will be done using quantitative reverse transcription (qRT)-PCR.	Day 1, 48 hours after screening, within approximately 2 days before planned discharge (approximate hospitalization duration: 7 days)

External Links

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