NCT05913700

Brief Summary

Study design is multicenter prospective registry study. Participants are consecutive (non-selected, a sequential registration) patients admitted from emergency rooms of participating hospitals who meet the eligibility criteria. The primary objectives are to estimate the prevalence of and risk factors for RS and other respiratory virus infection and their effect on hospital course in patients with any respiratory symptom who admit from emergency room using a multicenter prospective registry study. The primary target virus is RS virus and the secondary target viruses are respiratory virus and other microorganisms measured by FilmArray 2.1.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,067

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2023Sep 2026

First Submitted

Initial submission to the registry

May 25, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2025

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

May 25, 2023

Last Update Submit

July 16, 2025

Conditions

Respiratory Syncytial Virus (RSV)Respiratory Viral InfectionAcute Disease

Outcome Measures

Primary Outcomes (1)

  • RS virus infection

    Presence of RS virus infection measured by FilmArray 2.1

    On admission

Secondary Outcomes (28)

  • Respiratory virus and other microorganisms

    On admission

  • RS virus infection measured by paired serologic tests

    4 weeks

  • Lower respiratory tract infections

    On admission

  • All-cause mortality

    30 days

  • All-cause mortality

    180 days

  • +23 more secondary outcomes

Other Outcomes (2)

  • Number of safety outcome

    4 weeks

  • Number of any adverse events

    180 days

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive (non-selected, a sequential registration) patients admitted from emergency rooms of participating hospitals who meet the eligibility criteria.

You may qualify if:

  • Aged 50 years or older
  • Admission from emergency room
  • Having at least one of following respiratory symptoms/signs for at least 24 hours and the onset date of first symptom/sign less than 7 days before admission, which meet the acute respiratory infection (ARI) case definition described below: nasal congestion, rhinorrhea, sore throat, cough, sputum, dyspnea, wheeze, crackles or rhonchi, tachypnea (\>=20 per minute), decreased saturation of oxygen (\< 95%), admission with oxygen supplementation

You may not qualify if:

  • Scheduled admission
  • Admission for trauma care
  • With nasopharyngeal cavity diseases or deformity which block the nasopharyngeal sampling
  • Admission for end of life
  • Decline to participate the study by either informed consent or opt-out method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rakuwakai Otowa Hospital

Kyoto, Kyoto, 607-8062, Japan

Location

Nara City Hospital

Nara, Nara, 630-8305, Japan

Location

Shimane Prefectural Central Hospital

Izumo, Shimane, 693-8555, Japan

Location

Related Publications (1)

  • Morimoto T, Morikawa T, Imura H, Nezu M, Hamazaki K, Sakuma M, Chaumont A, Moitinho de Almeida M, Moreno VP, Ho Y, Harrington L, Matsuki T, Nakamura T. Rationale and protocol for a prospective cohort study of respiratory viral infections in patients admitted from emergency departments of community hospitals: Effect of respiratory Virus infection on EmeRgencY admission (EVERY) study. BMJ Open. 2024 Apr 15;14(4):e081037. doi: 10.1136/bmjopen-2023-081037.

    PMID: 38626982DERIVED

MeSH Terms

Conditions

Acute Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tsukasa Nakamura, MD, PhD

    Shimane Prefectural Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 22, 2023

Study Start

July 1, 2023

Primary Completion

January 22, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

JP(3)