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Active, Not Recruiting

NCT Number: NCT05913700

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Respiratory Syncytial Virus (RSV) Acute Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Viral Infection

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rakuwakai Otowa Hospital, Kyoto, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. RS virus infection

    Time frame: On admission

    Presence of RS virus infection measured by FilmArray 2.1

Secondary outcomes

  1. Respiratory virus and other microorganisms

    Time frame: On admission

    Presence of respiratory virus and other microorganisms measured by FilmArray 2.1

  2. RS virus infection measured by paired serologic tests

    Time frame: 4 weeks

    Presence of RS virus infection measured by paired serologic tests (neutralizing antibody method)

  3. Lower respiratory tract infections

    Time frame: On admission

    Presence of at least 2 lower respiratory symptoms/signs for at least 24 hours including at least 1 lower respiratory sign or presence of at least 3 lower respiratory symptoms for at least 24 hours according to the Table S2 from the following reference.

    Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595-608

  4. All-cause mortality

    Time frame: 30 days

    All-cause mortality

  5. All-cause mortality

    Time frame: 180 days

    All-cause mortality

  6. All-cause readmission

    Time frame: 180 days

    All-cause readmission

  7. Length of hospital stay

    Time frame: 30 days

    Length of hospital stay

  8. Changes in clinical frailty scale

    Time frame: 30 days

    The clinical frailty scale is scored from 1 (very fit) to 9 (terminally ill) according to the following reference.

    Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ 2005;173:489-95

  9. Changes in functional oral intake score

    Time frame: 30 days

    The functional oral intake score is scored from 1 (nothing by mouth) to 7 (total oral diet with no restriction) according to the following reference.

    Crary MA, Mann GD, Groher ME. Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil 2005;86:1516-20

  10. Changes in modified Rankin Scale

    Time frame: 30 days

    The modified Rankin Scale is scored from 0 (no symptoms) to 6 (death) according to the following reference.

    van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988;19:604-7

  11. Presence of nasal congestion or rhinorrhea

    Time frame: 30 days

    Presence of nasal congestion or rhinorrhea is defined by the Table S2 from the following reference.

    Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595-608

  12. Presence of sore throat

    Time frame: 30 days

    Presence of sore throat is defined by the Table S2 from the following reference.

    Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595-608

  13. Presence of cough

    Time frame: 30 days

    Presence of cough is defined by the Table S2 from the following reference. Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595-608

  14. Presence of sputum

    Time frame: 30 days

    Presence of sputum is defined by the Table S2 from the following reference. Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595-608

  15. Presence of dyspnea

    Time frame: 30 days

    Presence of dyspnea is defined by the Table S2 from the following reference. Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595-608

  16. Presence of wheeze

    Time frame: 30 days

    Presence of wheeze is defined by the Table S2 from the following reference. Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595-608

  17. Presence of crackles or rhonchi

    Time frame: 30 days

    Presence of crackles or rhonchi is defined by the Table S2 from the following reference.

    Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595-608

  18. Presence of tachypnea

    Time frame: 30 days

    Tachypnea is defined as respiratory rate ≥20 respirations/minute.

  19. Presence of decreased oxygen saturation

    Time frame: 30 days

    Decreased oxygen saturation is defined as <95% or ≤90% if baseline oxygen saturation is <95%.

  20. Presence of oxygen supplementation

    Time frame: 30 days

    Oxygen supplementation is any supplementation of oxygen including nasal, nasal high-flow supply, oxygen mask, ventilator, or extracorporeal membrane oxygenation.

  21. Length from onset to admission of acute respiratory infection symptoms

    Time frame: 7 days

    Length from onset to admission of acute respiratory infection symptoms

  22. Presence of family member who attends preschool or school

    Time frame: On admission

    Presence of family member who attends preschool or school

  23. Presence of symptoms of family member

    Time frame: On admission

    Family member is defined as those who live with the patient. Symptoms include fever, nasal congestion, rhinorrhea, sore throat, cough, sputum, dyspnea, or wheeze according to the Table S2 from the following reference.

    Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595-608

  24. Use of antimicrobials

    Time frame: 30 days

    Use of any antimicrobials during the hospital stay

  25. Admission to intensive or high care unit

    Time frame: 30 days

    Admission to intensive or similar high care unit

  26. Respiratory complications

    Time frame: 30 days

    Each of following respiratory complications is separately assessed: pneumonia, respiratory failure, fever

  27. Cardiovascular complications

    Time frame: 30 days

    Each of following cardiovascular complications is separately assessed: ischemic heart diseases, atrial fibrillations, valvular heart disease, heart failure necessitating drug therapy, deep venous thromboembolism or pulmonary embolism, peripheral artery disease necessitating drug therapy, hypertension necessitating drug therapy

  28. Cerebrovascular complications

    Time frame: 30 days

    Each of following cerebrovascular complications is separately assessed: ischemic stroke (excluding transient ischemic attack), intracranial hemorrhage, subarachnoid hemorrhage

Other outcomes

  1. Number of safety outcome

    Time frame: 4 weeks

    Insert site bleeding or peripheral nerve injury by blood drawing

  2. Number of any adverse events

    Time frame: 180 days

    Any adverse events which are considered to be related to the study by site investigators

Sponsors and collaborators

Lead sponsor

Institute for Clinical Effectiveness, Japan

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Acronym: EVERY

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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