Respiratory Syncytial Virus (RSV)EVERYNCT05913700
Effect of Respiratory Virus Infection on EmeRgencY Admission Study (EVERY Study)
An observational study of Respiratory Syncytial Virus (RSV) and Respiratory Viral Infection, run by Institute for Clinical Effectiveness, Japan at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Respiratory Syncytial Virus (RSV), Respiratory Viral Infection, Acute Disease
- How many people
- 3,067 participants
- Where
- 3 sitesJapan
- Study dates
- 1 Jul 2023to 30 Sep 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive (non-selected, a sequential registration) patients admitted from emergency rooms of participating hospitals who meet the eligibility criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Shimane Prefectural Central Hospital
Izumo, Shimane, 693-8555
Rakuwakai Otowa Hospital
Kyoto, Kyoto, 607-8062
Nara City Hospital
Nara, Nara, 630-8305
About this 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 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.
Read the 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.
- Medical subject headings
- Acute Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
RS virus infection
Presence of RS virus infection measured by FilmArray 2.1
Measured: On admission
Secondary outcomes (28)
Respiratory virus and other microorganisms
Presence of respiratory virus and other microorganisms measured by FilmArray 2.1
Measured: On admission
RS virus infection measured by paired serologic tests
Presence of RS virus infection measured by paired serologic tests (neutralizing antibody method)
Measured: 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
Measured: On admission
All-cause mortality
All-cause mortality
Measured: 30 days
All-cause mortality
All-cause mortality
Measured: 180 days
All-cause readmission
All-cause readmission
Measured: 180 days
Length of hospital stay
Length of hospital stay
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
Presence of tachypnea
Tachypnea is defined as respiratory rate ≥20 respirations/minute.
Measured: 30 days
Presence of decreased oxygen saturation
Decreased oxygen saturation is defined as <95% or ≤90% if baseline oxygen saturation is <95%.
Measured: 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.
Measured: 30 days
Length from onset to admission of acute respiratory infection symptoms
Length from onset to admission of acute respiratory infection symptoms
Measured: 7 days
Presence of family member who attends preschool or school
Presence of family member who attends preschool or school
Measured: 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
Measured: On admission
Use of antimicrobials
Use of any antimicrobials during the hospital stay
Measured: 30 days
Admission to intensive or high care unit
Admission to intensive or similar high care unit
Measured: 30 days
Respiratory complications
Each of following respiratory complications is separately assessed: pneumonia, respiratory failure, fever
Measured: 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
Measured: 30 days
Cerebrovascular complications
Each of following cerebrovascular complications is separately assessed: ischemic stroke (excluding transient ischemic attack), intracranial hemorrhage, subarachnoid hemorrhage
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023
- Primary completion22 Jan 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,067 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Tsukasa Nakamura, MD, PhD, Principal investigator, Shimane Prefectural Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913700
- Sponsor's protocol ID
- ICE_2023_01C
- Acronym
- EVERY
- Status last verified
- Jul 2025
- First submitted
- 25 May 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morimoto T, Morikawa T, Imura H, Nezu M, Hamazaki K, Sakuma M, Chaumont A, Moitinho de Almeida M, Moreno VP, Ho Y, Harrington L, Matsuki T, Nakamura T. Rationale and protocol for a prospective cohort study of respiratory viral infections in patients admitted from emergency departments of community hospitals: Effect of respiratory Virus infection on EmeRgencY admission (EVERY) study. BMJ Open. 2024 Apr 15;14(4):e081037. doi: 10.1136/bmjopen-2023-081037.
PubMed 38626982
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05913700
- Acronym / sponsor ID
- EVERY / ICE_2023_01C
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,067 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness, JapanUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive (non-selected, a sequential registration) patients admitted from emergency rooms of participating hospitals who meet the eligibility criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RS virus infection
Time frame: On admission
Presence of RS virus infection measured by FilmArray 2.1
28 secondary outcomes
Respiratory virus and other microorganisms
Time frame: On admission
RS virus infection measured by paired serologic tests
Time frame: 4 weeks
Lower respiratory tract infections
Time frame: On admission
All-cause mortality
Time frame: 30 days
All-cause mortality
Time frame: 180 days
All-cause readmission
Time frame: 180 days
Length of hospital stay
Time frame: 30 days
Changes in clinical frailty scale
Time frame: 30 days
Changes in functional oral intake score
Time frame: 30 days
Changes in modified Rankin Scale
Time frame: 30 days
Presence of nasal congestion or rhinorrhea
Time frame: 30 days
Presence of sore throat
Time frame: 30 days
Presence of cough
Time frame: 30 days
Presence of sputum
Time frame: 30 days
Presence of dyspnea
Time frame: 30 days
Presence of wheeze
Time frame: 30 days
Presence of crackles or rhonchi
Time frame: 30 days
Presence of tachypnea
Time frame: 30 days
Presence of decreased oxygen saturation
Time frame: 30 days
Presence of oxygen supplementation
Time frame: 30 days
Length from onset to admission of acute respiratory infection symptoms
Time frame: 7 days
Presence of family member who attends preschool or school
Time frame: On admission
Presence of symptoms of family member
Time frame: On admission
Use of antimicrobials
Time frame: 30 days
Admission to intensive or high care unit
Time frame: 30 days
Respiratory complications
Time frame: 30 days
Cardiovascular complications
Time frame: 30 days
Cerebrovascular complications
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Derived from this study: PubMed 38626982Morimoto T, Morikawa T, Imura H, Nezu M, Hamazaki K, Sakuma M, Chaumont A, Moitinho de Almeida M, Moreno VP, Ho Y, Harrington L, Matsuki T, Nakamura T. Rationale and protocol for a prospective cohort study of respiratory viral infections in patients admitted from emergency departments of community hospitals: Effect of respiratory Virus infection on EmeRgencY admission (EVERY) study. BMJ Open. 2024 Apr 15;14(4):e081037. doi: 10.1136/bmjopen-2023-081037.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsukasa Nakamura, MD, PhD principal investigator
Shimane Prefectural Central Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus (RSV) and Respiratory Viral Infection, run by Institute for Clinical Effectiveness, Japan at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RS virus infection (time frame: On admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.