A Study of Acute Respiratory Infections in Global Outpatient Setting
- Conditions
- Acute Respiratory Infection
- Interventions
- Diagnostic Test: Nasal Swab Sample
- Registration Number
- NCT05148780
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to evaluate the positivity rate of respiratory syncytial virus (RSV), influenza virus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in high-risk participants presenting with acute respiratory infections (ARIs) in outpatient settings during the influenza/RSV season and to evaluate the association between lower respiratory tract disease (LRTD) and ARI-related hospitalization in participants positive for RSV.
- Detailed Description
Lower respiratory tract infections (LRTIs) are a major cause of mortality and morbidity worldwide with 2.3 million deaths in 2016 alone among all age groups, making it the sixth leading cause of mortality. The current study aims to assess the burden of RSV infections among adult participants presenting in outpatient settings, who are at high risk of complications or progression to severe disease due to their age or pre-existing comorbidities. Regional data from the United States (US), Europe, Middle East, and Asia (EMEA) and Asia-Pacific (APAC) will provide evidence on local RSV morbidity, mortality, medical resource utilization (MRU), standard of care, and quality of life in adults participants. A subset of participants positive for influenza virus and/or SARS-CoV-2 will also be enrolled, to allow for a comparative assessment of disease burden between the 3 viral respiratory pathogens. No study drug will be involved in this study. The total duration of the study for each participant will be a maximum of 3 months (+-1 week) from the date of enrollment. Safety will be assessed in the form of adverse events and serious adverse events related to study devices or procedures and for deaths regardless of causality.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
- Present to the general physician (GP)/specialist outpatient settings/respiratory clinics or in Emergency department (ED) settings with symptoms suggestive of a diagnosis of Acute Respiratory Infections (ARI)
- For inclusion in the home-based follow-up phases, must test positive for respiratory syncytial virus (RSV) and/or influenza and/or Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) per a molecular-based diagnostic assay (polymerase chain reaction [PCR]-based) using a nasal swab (nasopharyngeal or similar) sample. Co-infections are permitted to be enrolled in the study
- Must be able to read, understand, and complete questionnaires
- Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- Willing and able to adhere to the specifications in this protocol
- Has a clinical condition other than those as specified in study protocol which, in the opinion of the investigator, could prevent, confound, or limit the protocol-specified assessments
- Received an investigational drug (including investigational vaccines) within 3 months before the start of the study or the first data collection time-point
- Is currently enrolled or plans to participate in another investigational study on RSV, influenza or SARS-CoV-2 during the current study
- Is, in the opinion of the investigator, unlikely to adhere to the requirements of the study, or is unlikely to complete the full course of observation
- Cannot communicate reliably with the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants with Acute Respiratory Infections (ARI) in Outpatient Setting Nasal Swab Sample Participants presenting with ARIs in an outpatient setting who are at high risk of progressing to severe disease will be screened for viral respiratory pathogens (respiratory syncytial virus \[RSV\], Influenza, severe acute respiratory syndrome coronavirus 2 \[SARS-COV-2\]) by collecting a nasal swab. If a participant is positive for RSV and/or influenza virus and/or SARS-CoV-2 based on a study test or standard-of-care (SOC) polymerase chain reaction (PCR)-based test, the participant will be eligible for enrollment in the study in the home-based short-term and long-term follow-up phases.
- Primary Outcome Measures
Name Time Method Percentage of Participants Positive for Respiratory Syncytial Virus (RSV) Day 1 Percentage of participants positive for RSV, among those screened for viral pathogens using a polymerase chain reaction (PCR)-based test will be reported.
Percentage of Participants Positive for Influenza Virus Day 1 Percentage of participants positive for influenza virus, among those screened for viral pathogens using a PCR-based test will be reported.
Percentage of Participants Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Day 1 Percentage of participants positive for SARS-CoV-2, among those screened for viral pathogens using a PCR- based test will be reported
Number of Participants with Relative Risk of Acute Respiratory Infections (ARI)- related Hospitalization in Participants Positive for RSV with Lower Respiratory Tract Disease (LRTD) or Without LRTD Up to 3 months Number of participants with relative risk of ARI-related hospitalization in participants positive for RSV with LRTD or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the Respiratory Infection Intensity and Impact Questionnaire (RiiQTM) V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing.
- Secondary Outcome Measures
Name Time Method Time to ARI- related Hospitalization in Participants Positive for RSV Up to 3 months Time to ARI- related hospitalization in participants positive for RSV will be reported.
Time to ARI- related Hospitalization in Participants Positive for Influenza Virus Up to 3 months Time to ARI- related hospitalization in participants positive for influenza virus will be reported.
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for RSV Up to 3 months Time to ARI-related clinically relevant disease during the follow-up period in participants positive for RSV will be reported.
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for Influenza Virus Up to 3 months Time to ARI-related clinically relevant disease during the follow-up period in participants positive for influenza virus will be reported.
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for SARS-CoV-2 Up to 3 months Time to ARI-related clinically relevant disease during the follow-up period in participants positive for SARS-CoV-2 will be reported.
Time to ARI- related Hospitalization in Participants Positive for SARS-CoV-2 Up to 3 months Time to ARI- related hospitalization in participants positive for SARS-CoV-2 will be reported.
Time to ARI- related Complications During the Follow-up Period in Participants Positive for SARS-CoV-2 Up to 3 months Time to ARI- related complications during the follow-up period in participants positive for SARS-CoV-2 will be reported
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for SARS-CoV-2 with or Without LRTD Up to 3 months Number of participants with relative risk of ARI-related hospitalization in participants positive for SARS-CoV-2 with or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the RiiQTM V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing
Percentage of Participants Positive for RSV Reporting ARI-related Hospitalizations During the Study Period Up to 3 months Percentage of participants positive for RSV reporting ARI-related hospitalizations during the study period will be reported.
Percentage of Participants Positive for SARS-CoV-2 Reporting ARI-related Hospitalizations During the Study Period Up to 3 months Percentage of participants positive for SARS-CoV-2 reporting ARI-related hospitalizations during the study period will be reported.
Percentage of Participants Positive for Influenza Virus Reporting ARI-related Hospitalizations During the Study Period Up to 3 months Percentage of participants positive for influenza virus reporting ARI-related hospitalizations during the study period will be reported.
Percentage of Participants Presenting with Complications at Screening and Diagnosed with or Without LRTD Day 1 Percentage of participants presenting with complications at screening and diagnosed with or without LRTD will be reported.
Time to ARI- related Complications During the Follow-up Period in Participants Positive for Influenza Virus Up to 3 months Time to ARI- related complications during the follow-up period in participants positive for influenza virus will be reported.
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for Influenza Virus Diagnosed with or Without LRTD Up to 3 months Number of participants with relative risk of ARI-related hospitalization in participants positive for influenza virus diagnosed with or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the RiiQTM V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing.
Percentage of Participants Reporting ARI- related Complications During the Follow-up Period and Diagnosed with or Without LRTD Up to 3 months Percentage of participants reporting ARI- related complications during the follow-up period and diagnosed with or without LRTD will be reported.
Time to ARI- related Complications During the Follow-up Period in Participants Positive for RSV Up to 3 months Time to ARI- related complications during the follow-up period in participants positive for RSV will be reported.
Percentage of Participants Presenting with Clinically Relevant Disease at Screening and Diagnosed with or Without LRTD Day 1 Percentage of participants presenting with clinically relevant disease at screening and diagnosed with or without LRTD will be reported.
Percentage of Participants Reporting ARI- related Clinically Relevant Disease During the Follow-up Period and Diagnosed with or Without LRTD Up to 3 months Percentage of participants reporting ARI-related clinically relevant disease during the follow-up period and diagnosed with or without LRTD will be reported.
Related Research Topics
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Trial Locations
- Locations (70)
Kaohsiung Medical University Chung Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei, Taiwan
Taipei Medical University
🇨🇳Taipei City, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Gabinet Lekarski Pediatryczno-Alergologiczny
🇵🇱Bialystok, Poland
ETG Lodz
🇵🇱Lodz, Poland
EMC Instytut Medyczny SA PL CERTUS
🇵🇱Poznan, Poland
Cs Algeciras Norte
🇪🇸Algeciras, Spain
Hosp. Gral. Univ. de Alicante
🇪🇸Alicante, Spain
Eap Sardenya
🇪🇸Barcelona, Spain
Cap Apenins - Montigala
🇪🇸Caldes Montbui Canovelles, Spain
Cap Canet de Mar
🇪🇸Canet de Mar, Spain
Hosp. Clinico San Carlos
🇪🇸Madrid, Spain
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Klinik Kesihatan Putrajaya Presint 9
🇲🇾Kuala Lumpur, Malaysia
Klinik Kesihatan Kuang
🇲🇾Kuang, Malaysia
Klinik Kesihatan Masjid Tanah
🇲🇾Masjid Tanah, Malaysia
NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
🇵🇱Katowice, Poland
NZOZ Leczniczo Rehabilitacyjny Osrodek Medycyny Rodzinnej
🇵🇱Wroclaw, Poland
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Lakeview Clinical Research
🇺🇸Guntersville, Alabama, United States
Synexus Clinical Research US Inc
🇺🇸Mesa, Arizona, United States
Fiel Family and Sports Medicine Clinical Research Advantage
🇺🇸Phoenix, Arizona, United States
Harrisburg Family Medical Center
🇺🇸Harrisburg, Arkansas, United States
Innovative Research of West Florida, Incorporated
🇺🇸Clearwater, Florida, United States
New Life Medical Research Center, Inc.
🇺🇸Hialeah, Florida, United States
Best Quality Research Inc
🇺🇸Hialeah, Florida, United States
PharmaDUX Clinical Medical Research, LLC
🇺🇸Medley, Florida, United States
Homestead Associates in Research,Inc
🇺🇸Miami, Florida, United States
Alma Clinical Research
🇺🇸Miami, Florida, United States
Research Institute of South Florida Inc
🇺🇸Miami, Florida, United States
Pines Care Research Center Inc
🇺🇸Pembroke Pines, Florida, United States
Santos Research Center
🇺🇸Tampa, Florida, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
IACT Health
🇺🇸Suffolk, Virginia, United States
Snake River Research, PLLC
🇺🇸Idaho Falls, Idaho, United States
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States
Montana Medical Research
🇺🇸Missoula, Montana, United States
Healor Primary Care
🇺🇸Las Vegas, Nevada, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Santa Rosa Medical Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Urgent Care Clinical Trials at AFC Urgent Care
🇺🇸Easley, South Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
American Health Network, LLC
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
DayStar Clinical Research, Inc.
🇺🇸Akron, Ohio, United States
Premier Family Physicians
🇺🇸Carrollton, Texas, United States
Next Level Urgent Care
🇺🇸Corpus Christi, Texas, United States
Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Urgent Care Clinical Trials Fort Worth
🇺🇸Fort Worth, Texas, United States
Southwest Clinical Trials
🇺🇸Houston, Texas, United States
Renovatio Clinical
🇺🇸Magnolia, Texas, United States
Benchmark Research
🇺🇸San Angelo, Texas, United States
CCT Research at Olympus Family Medicine
🇺🇸Holladay, Utah, United States
CCT Research at South Ogden Family Medicine
🇺🇸Ogden, Utah, United States
Clinical Research Partners, LLC
🇺🇸Henrico, Virginia, United States
ALTA Clinical Research Inc.
🇨🇦Edmonton, Alberta, Canada
CHU Grenoble
🇫🇷La Tronche, France
Hopital Edouard Herriot - CHU Lyon
🇫🇷Lyon, France
CHU Nimes Hopital Caremeau
🇫🇷Nimes, France
Fujita Health University Hospital
🇯🇵Date-gun, Japan
Hanasaki Clinic
🇯🇵Kiyosu-shi, Japan
Miyagikoseikyokai Saka General Hospital
🇯🇵Shiogama, Japan
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Hospital Miri
🇲🇾Miri, Malaysia
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Taipei Municipal Wanfang Hospital
🇨🇳Taipei, Taiwan
The Adam Practice
🇬🇧Wirral, United Kingdom