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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
United States, Argentina, Brazil, Canada, France, Germany, Korea, Republic of, Malaysia, Mexico, Singapore, South Africa,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Terminated |
NCT04583280 -
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
|
Phase 3 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Active, not recruiting |
NCT03251196 -
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
|
||
Completed |
NCT02561871 -
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT01911143 -
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
|
N/A | |
Terminated |
NCT02032056 -
Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period
|
N/A | |
Completed |
NCT01419262 -
DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
|
Phase 3 | |
Terminated |
NCT01432080 -
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
|
Phase 2 | |
Completed |
NCT00984945 -
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
|
Phase 1 | |
Completed |
NCT00127686 -
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
|
Phase 1 | |
Active, not recruiting |
NCT01107223 -
Long Term Effect of General Practitioner Education on Antibiotic Prescribing
|
N/A | |
Completed |
NCT03739112 -
Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly
|
Phase 3 | |
Completed |
NCT04144491 -
Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda
|
N/A | |
Completed |
NCT05318235 -
Virus Interactions in the Respiratory Tract; a Cohort Study With Children
|
||
Active, not recruiting |
NCT04170348 -
Daily Vitamin D for Sickle-cell Respiratory Complications
|
Phase 2 | |
Completed |
NCT04525040 -
ProbioKid as Prevention Among Kids With Frequent URTI
|
N/A | |
Completed |
NCT05535777 -
Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS)
|
N/A | |
Not yet recruiting |
NCT05914324 -
Outpatient Pediatric Pulse Oximeters in Africa
|
N/A |