An observational study in Respiratory Syncytial Virus (RSV), Respiratory Viral Infection and Acute Disease, sponsored by Institute for Clinical Effectiveness, Japan. Active, not recruiting at 3 sites in Japan. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by Institute for Clinical Effectiveness, Japan · Observational
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.
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.
285 studies on the registry are indexed under Acute Disease; 39 are open to participants now.
This study's enrollment of 3,067 is above the median of 200 across 83 observational studies indexed under Acute Disease.
Browse Acute Disease studies →Institute for Clinical Effectiveness, Japan is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive (non-selected, a sequential registration) patients admitted from emergency rooms of participating hospitals who meet the eligibility criteria.
Exclusion Criteria:
RS virus infection
Presence of RS virus infection measured by FilmArray 2.1
Time frame: On admission
Respiratory virus and other microorganisms
Presence of respiratory virus and other microorganisms measured by FilmArray 2.1
Time frame: On admission
RS virus infection measured by paired serologic tests
Presence of RS virus infection measured by paired serologic tests (neutralizing antibody method)
Time frame: 4 weeks
Lower respiratory tract infections
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
Time frame: On admission
All-cause mortality
All-cause mortality
Time frame: 30 days
All-cause mortality
All-cause mortality
Time frame: 180 days
All-cause readmission
All-cause readmission
Time frame: 180 days
Length of hospital stay
Length of hospital stay
Time frame: 30 days
Changes in clinical frailty scale
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
Time frame: 30 days
Changes in functional oral intake score
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
Time frame: 30 days
Changes in modified Rankin Scale
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
Time frame: 30 days
Presence of nasal congestion or rhinorrhea
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
Time frame: 30 days
Presence of sore throat
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
Time frame: 30 days
Presence of cough
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
Time frame: 30 days
Presence of sputum
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
Time frame: 30 days
Presence of dyspnea
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
Time frame: 30 days
Presence of wheeze
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
Time frame: 30 days
Presence of crackles or rhonchi
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
Time frame: 30 days
Presence of tachypnea
Tachypnea is defined as respiratory rate ≥20 respirations/minute.
Time frame: 30 days
Presence of decreased oxygen saturation
Decreased oxygen saturation is defined as \<95% or ≤90% if baseline oxygen saturation is \<95%.
Time frame: 30 days
Presence of oxygen supplementation
Oxygen supplementation is any supplementation of oxygen including nasal, nasal high-flow supply, oxygen mask, ventilator, or extracorporeal membrane oxygenation.
Time frame: 30 days
Length from onset to admission of acute respiratory infection symptoms
Length from onset to admission of acute respiratory infection symptoms
Time frame: 7 days
Presence of family member who attends preschool or school
Presence of family member who attends preschool or school
Time frame: On admission
Presence of symptoms of family member
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
Time frame: On admission
Use of antimicrobials
Use of any antimicrobials during the hospital stay
Time frame: 30 days
Admission to intensive or high care unit
Admission to intensive or similar high care unit
Time frame: 30 days
Respiratory complications
Each of following respiratory complications is separately assessed: pneumonia, respiratory failure, fever
Time frame: 30 days
Cardiovascular complications
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
Time frame: 30 days
Cerebrovascular complications
Each of following cerebrovascular complications is separately assessed: ischemic stroke (excluding transient ischemic attack), intracranial hemorrhage, subarachnoid hemorrhage
Time frame: 30 days
Number of safety outcome
Insert site bleeding or peripheral nerve injury by blood drawing
Time frame: 4 weeks
Number of any adverse events
Any adverse events which are considered to be related to the study by site investigators
Time frame: 180 days
Plan to share: No
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Institute for Clinical Effectiveness, Japan