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A Study of Acute Respiratory Infections in Global Outpatient Setting

NCT05148780 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2025-02-03

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Infection

Interventions

DIAGNOSTIC_TEST

Nasal Swab Sample

Nasal swab sample will be used to screen participants for detection of viral pathogens. No intervention or study drug will be administered as part of this study.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-02-20
Completion
2023-02-22
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Japan
  • Malaysia
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148780 on ClinicalTrials.gov