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

Last updated: June 9, 2024
Sponsor: Institute for Clinical Effectiveness, Japan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv)

Treatment

N/A

Clinical Study ID

NCT05913700
ICE_2023_01C
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 50 years or older

  • Admission from emergency room

  • Having at least one of following respiratory symptoms/signs for at least 24 hoursand the onset date of first symptom/sign less than 7 days before admission, whichmeet the acute respiratory infection (ARI) case definition described below: nasalcongestion, rhinorrhea, sore throat, cough, sputum, dyspnea, wheeze, crackles orrhonchi, tachypnea (>=20 per minute), decreased saturation of oxygen (< 95%),admission with oxygen supplementation

Exclusion

Exclusion Criteria:

  • Scheduled admission

  • Admission for trauma care

  • With nasopharyngeal cavity diseases or deformity which block the nasopharyngealsampling

  • Admission for end of life

  • Decline to participate the study by either informed consent or opt-out method

Study Design

Total Participants: 3000
Study Start date:
July 01, 2023
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Shimane Prefectural Central Hospital

    Izumo, Shimane 693-8555
    Japan

    Active - Recruiting

  • Rakuwakai Otowa Hospital

    Kyoto, 607-8062
    Japan

    Active - Recruiting

  • Nara City Hospital

    Nara, 630-8305
    Japan

    Active - Recruiting

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