Effect of Respiratory Virus Infection on EmeRgencY Admission Study (EVERY Study)
- Conditions
- Respiratory Viral InfectionRespiratory Syncytial Virus (RSV)Acute Disease
- Registration Number
- NCT05913700
- Lead Sponsor
- Institute for Clinical Effectiveness, Japan
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RS virus infection On admission Presence of RS virus infection measured by FilmArray 2.1
- Secondary Outcome Measures
Name Time Method All-cause readmission 180 days All-cause readmission
Presence of oxygen supplementation 30 days Oxygen supplementation is any supplementation of oxygen including nasal, nasal high-flow supply, oxygen mask, ventilator, or extracorporeal membrane oxygenation.
Respiratory virus and other microorganisms On admission Presence of respiratory virus and other microorganisms measured by FilmArray 2.1
Changes in modified Rankin Scale 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;19:604-7Presence of decreased oxygen saturation 30 days Decreased oxygen saturation is defined as \<95% or ≤90% if baseline oxygen saturation is \<95%.
Lower respiratory tract infections 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;388:595-608Presence of cough 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
All-cause mortality 180 days All-cause mortality
Presence of dyspnea 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
Presence of crackles or rhonchi 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;388:595-608Presence of family member who attends preschool or school On admission Presence of family member who attends preschool or school
RS virus infection measured by paired serologic tests 4 weeks Presence of RS virus infection measured by paired serologic tests (neutralizing antibody method)
Length of hospital stay 30 days Length of hospital stay
Changes in clinical frailty scale 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;173:489-95Changes in functional oral intake score 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;86:1516-20Presence of nasal congestion or rhinorrhea 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;388:595-608Presence of wheeze 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
Presence of tachypnea 30 days Tachypnea is defined as respiratory rate ≥20 respirations/minute.
Admission to intensive or high care unit 30 days Admission to intensive or similar high care unit
Presence of sore throat 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;388:595-608Presence of sputum 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
Length from onset to admission of acute respiratory infection symptoms 7 days Length from onset to admission of acute respiratory infection symptoms
Presence of symptoms of family member 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;388:595-608Use of antimicrobials 30 days Use of any antimicrobials during the hospital stay
Respiratory complications 30 days Each of following respiratory complications is separately assessed: pneumonia, respiratory failure, fever
Cardiovascular complications 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
Cerebrovascular complications 30 days Each of following cerebrovascular complications is separately assessed: ischemic stroke (excluding transient ischemic attack), intracranial hemorrhage, subarachnoid hemorrhage
Trial Locations
- Locations (3)
Shimane Prefectural Central Hospital
🇯🇵Izumo, Shimane, Japan
Nara City Hospital
🇯🇵Nara, Japan
Rakuwakai Otowa Hospital
🇯🇵Kyoto, Japan