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

Respiratory Syncytial Virus (RSV) Clinical Trial

— EVERY  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913700
• Other study ID #: ICE_2023_01C
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2023
• Source: Institute for Clinical Effectiveness, Japan
• Contact: Takeshi Morimoto, MD, PhD, MPH
• Phone: +81-75-778-5054
• Email: ceo[@]icekyoto.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Infections
• Respiratory Syncytial Virus (RSV)
• Respiratory Viral Infection
• Virus Diseases

Locations

Country	Name	City	State
Japan	Shimane Prefectural Central Hospital	Izumo	Shimane
Japan	Rakuwakai Otowa Hospital	Kyoto
Japan	Nara City Hospital	Nara

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical Effectiveness, Japan	GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of safety outcome	Insert site bleeding or peripheral nerve injury by blood drawing	4 weeks
Other	Number of any adverse events	Any adverse events which are considered to be related to the study by site investigators	180 days
Primary	RS virus infection	Presence of RS virus infection measured by FilmArray 2.1	On admission
Secondary	Respiratory virus and other microorganisms	Presence of respiratory virus and other microorganisms measured by FilmArray 2.1	On admission
Secondary	RS virus infection measured by paired serologic tests	Presence of RS virus infection measured by paired serologic tests (neutralizing antibody method)	4 weeks
Secondary	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	On admission
Secondary	All-cause mortality	All-cause mortality	30 days
Secondary	All-cause mortality	All-cause mortality	180 days
Secondary	All-cause readmission	All-cause readmission	180 days
Secondary	Length of hospital stay	Length of hospital stay	30 days
Secondary	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	30 days
Secondary	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	30 days
Secondary	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	30 days
Secondary	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	30 days
Secondary	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	30 days
Secondary	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	30 days
Secondary	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	30 days
Secondary	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	30 days
Secondary	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	30 days
Secondary	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	30 days
Secondary	Presence of tachypnea	Tachypnea is defined as respiratory rate =20 respirations/minute.	30 days
Secondary	Presence of decreased oxygen saturation	Decreased oxygen saturation is defined as <95% or =90% if baseline oxygen saturation is <95%.	30 days
Secondary	Presence of oxygen supplementation	Oxygen supplementation is any supplementation of oxygen including nasal, nasal high-flow supply, oxygen mask, ventilator, or extracorporeal membrane oxygenation.	30 days
Secondary	Length from onset to admission of acute respiratory infection symptoms	Length from onset to admission of acute respiratory infection symptoms	7 days
Secondary	Presence of family member who attends preschool or school	Presence of family member who attends preschool or school	On admission
Secondary	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	On admission
Secondary	Use of antimicrobials	Use of any antimicrobials during the hospital stay	30 days
Secondary	Admission to intensive or high care unit	Admission to intensive or similar high care unit	30 days
Secondary	Respiratory complications	Each of following respiratory complications is separately assessed: pneumonia, respiratory failure, fever	30 days
Secondary	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	30 days
Secondary	Cerebrovascular complications	Each of following cerebrovascular complications is separately assessed: ischemic stroke (excluding transient ischemic attack), intracranial hemorrhage, subarachnoid hemorrhage	30 days