Clinical trial NCT05913700: Effect of Respiratory Virus Infection on EmeRgencY Admission Study (EVERY Study)
Official title: Estimation of Prevalence of and Risk Factor for Respiratory Viruses Among Emergently Admitted Adult Patients With Respiratory Symptoms and Their Influence on Clinical Outcomes in the Settings From Rural to Urban Community Hospitals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Syncytial Virus (RSV)
Respiratory Viral Infection
Acute Disease
Lead sponsor: Institute for Clinical Effectiveness, Japan
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2023-06-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive (non-selected, a sequential registration) patients admitted from emergency rooms of participating hospitals who meet the eligibility criteria.

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.

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

Primary outcomes:
measure: RS virus infection
timeFrame: On admission
Secondary outcomes:
measure: Respiratory virus and other microorganisms
timeFrame: On admission
measure: RS virus infection measured by paired serologic tests
timeFrame: 4 weeks
measure: Lower respiratory tract infections
timeFrame: On admission
measure: All-cause mortality
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 180 days
measure: All-cause readmission
timeFrame: 180 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Changes in clinical frailty scale
timeFrame: 30 days
measure: Changes in functional oral intake score
timeFrame: 30 days
measure: Changes in modified Rankin Scale
timeFrame: 30 days
measure: Presence of nasal congestion or rhinorrhea
timeFrame: 30 days
measure: Presence of sore throat
timeFrame: 30 days
measure: Presence of cough
timeFrame: 30 days
measure: Presence of sputum
timeFrame: 30 days
measure: Presence of dyspnea
timeFrame: 30 days
measure: Presence of wheeze
timeFrame: 30 days
measure: Presence of crackles or rhonchi
timeFrame: 30 days
measure: Presence of tachypnea
timeFrame: 30 days
measure: Presence of decreased oxygen saturation
timeFrame: 30 days
measure: Presence of oxygen supplementation
timeFrame: 30 days
measure: Length from onset to admission of acute respiratory infection symptoms
timeFrame: 7 days
measure: Presence of family member who attends preschool or school
timeFrame: On admission
measure: Presence of symptoms of family member
timeFrame: On admission
measure: Use of antimicrobials
timeFrame: 30 days
measure: Admission to intensive or high care unit
timeFrame: 30 days
measure: Respiratory complications
timeFrame: 30 days
measure: Cardiovascular complications
timeFrame: 30 days
measure: Cerebrovascular complications
timeFrame: 30 days
Other outcomes:
measure: Number of safety outcome
timeFrame: 4 weeks
measure: Number of any adverse events
timeFrame: 180 days
Locations:
city: Izumo
country: Japan
facility: Shimane Prefectural Central Hospital
state: Shimane
city: Kyoto
country: Japan
facility: Rakuwakai Otowa Hospital
city: Nara
country: Japan
facility: Nara City Hospital
Study officials:
affiliation: Shimane Prefectural Central Hospital
name: Tsukasa Nakamura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: