A Study of Acute Respiratory Infections in Global Outpatient Setting
Completed · Early Phase 1
Conditions studied: Acute Respiratory Infection
In brief
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.
Key facts
- Study ID
- NCT05148780
- Run by
- Janssen Research & Development, LLC
- People needed
- 245
- Starts
- 2021-12-20
- Expected to finish
- 2023-02-22
- Last updated by the study team
- 2025-02-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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 — Rincon, Georgia, United States
- Snake River Research, PLLC — Idaho Falls, Idaho, United States
- Washington University School Of Medicine — St 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 — The Bronx, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Hanasaki Clinic — Kiyosu-shi, Japan
Full record on ClinicalTrials.gov
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