Acute Disease, Respiratory Syncytial Virus (RSV), Respiratory Viral Infection
Conditions
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.
Interventions
None listed
Sponsors
GlaxoSmithKline
Institute for Clinical Effectiveness, Japan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RS virus infection | On admission | Presence of RS virus infection measured by FilmArray 2.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of tachypnea | 30 days | Tachypnea is defined as respiratory rate ≥20 respirations/minute. |
| Respiratory virus and other microorganisms | On admission | Presence of respiratory virus and other microorganisms measured by FilmArray 2.1 |
| RS virus infection measured by paired serologic tests | 4 weeks | Presence of RS virus infection measured by paired serologic tests (neutralizing antibody method) |
| 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;388:595-608 |
| All-cause mortality | 30 days | All-cause mortality |
| All-cause readmission | 180 days | All-cause readmission |
| 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;173:489-95 |
| Changes 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;86:1516-20 |
| 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;19:604-7 |
| Presence 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;388:595-608 |
| 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;388:595-608 |
| Presence 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 |
| Presence of decreased oxygen saturation | 30 days | Decreased oxygen saturation is defined as \<95% or ≤90% if baseline oxygen saturation is \<95%. |
| 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 |
| Presence 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 |
| 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 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 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;388:595-608 |
| 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. |
| Length from onset to admission of acute respiratory infection symptoms | 7 days | Length from onset to admission of acute respiratory infection symptoms |
| Presence of family member who attends preschool or school | On admission | Presence of family member who attends preschool or school |
| 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;388:595-608 |
| Use of antimicrobials | 30 days | Use of any antimicrobials during the hospital stay |
| Admission to intensive or high care unit | 30 days | Admission to intensive or similar high care unit |
| Respiratory complications | 30 days | Each of following respiratory complications is separately assessed: pneumonia, respiratory failure, fever |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of safety outcome | 4 weeks | Insert site bleeding or peripheral nerve injury by blood drawing |
| Number of any adverse events | 180 days | Any adverse events which are considered to be related to the study by site investigators |
Countries
Japan
Outcome results
None listed