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

Institute for Clinical Effectiveness, Japan

Status: Enrolling

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05913700

ICE_2023_01C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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