Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05913700
Study type Observational [Patient Registry]
Source Institute for Clinical Effectiveness, Japan
Contact Takeshi Morimoto, MD, PhD, MPH
Phone +81-75-778-5054
Email ceo@icekyoto.org
Status Recruiting
Phase
Start date July 1, 2023
Completion date September 30, 2026

See also
  Status Clinical Trial Phase
Completed NCT02593071 - Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year. Phase 2
Completed NCT02266628 - Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults Phase 2
Completed NCT02282982 - Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis N/A
Completed NCT01709019 - RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly Phase 1
Completed NCT01704365 - RSV-F Vaccine Dose Ranging Study in Young Women Phase 2
Recruiting NCT06185647 - Evaluation in Practice of the Impact of NIrsevimab on EmeRgency Use for BRONCHIOlitis
Recruiting NCT04925310 - Infection With Respiratory Syncytial Virus in Infants
Completed NCT02968173 - A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus Phase 3
Active, not recruiting NCT06077149 - Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF) Phase 4
Completed NCT02608502 - A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults Phase 3
Recruiting NCT05047549 - Community-based RSV Surveillance in Infant Mortality: Minimally Invasive Tissue Sampling Study in Karachi, Pakistan
Terminated NCT04225897 - A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection. Phase 2
Recruiting NCT06216093 - Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years Phase 1
Not yet recruiting NCT06392451 - LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia N/A
Completed NCT04927793 - Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects Phase 1
Active, not recruiting NCT05443607 - Transplacental Transmission of RSV (TTRSV)
Recruiting NCT04896853 - Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans® Phase 1
Completed NCT03916185 - Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age Phase 1/Phase 2
Completed NCT05842967 - A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease Phase 3
Recruiting NCT04909021 - Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months Phase 1