Effect of Respiratory Virus Infection on EmeRgencY Admission Study (EVERY Study)

NCT ID: NCT05913700

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3067 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-09-30

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.

Detailed Description

The investigators register consecutive patients who meet the eligibility criteria at 3 participating hospitals from electronic medical records. As a routine clinical practice, presence of respiratory symptoms using standard electronic medical record (EMR) format are universally assessed at the emergency room when the patients are determined to be admitted. Patients are registered if they meet the eligibility criteria and information of medical history, baseline characteristics, living status, physical findings, laboratory tests, chest X-ray, electrocardiogram, on admission are retrieved from the EMRs. The nasopharyngeal swab is obtained within 24 hours after admission as a standard practice, which will be sampled at either emergency rooms or hospital wards. The swab is transferred to the onsite laboratory office to measure the FilmArray 2.1 by trained technicians or physicians in charge.

Serum antibodies for RS virus are obtained from patients with suspected lower respiratory infection (bronchitis and pneumonia) who provided their written informed consent, at the timing of admission and 4 weeks after the admission.

Conditions

Respiratory Syncytial Virus (RSV); Respiratory Viral Infection; Acute Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Institute for Clinical Effectiveness, Japan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsukasa Nakamura, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shimane Prefectural Central Hospital

Locations

Rakuwakai Otowa Hospital

Kyoto, Kyoto, Japan

Nara City Hospital

Nara, Nara, Japan

Shimane Prefectural Central Hospital

Izumo, Shimane, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 38626982 (View on PubMed)

Other Identifiers

ICE_2023_01C

Identifier Type: -

Identifier Source: org_study_id