acute respiratory infection
Conditions
Interventions
None listed
Sponsors
Janssen Pharmaceutica NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is able to provide written informed consent prior to any study-related procedure(s). 2. Patient is capable to be compliant with the study related procedures, including being interviewed by phone. 3. Patient is 50y or older. 4. Patient is an inpatient OR patient is an outpatient, presenting for medical support to the emergency room, or outpatient clinic or in a private office. 5. For participation to the screening phase, patient is diagnosed with an ARI during the RSV season. The diagnosis of ARI will follow the standard medical procedure. 6. The onset of the acute respiratory symptoms was less than 7 days or 7 days ago. The time from initiation of clinical symptoms will refer to any of the following symptoms occurring or worsening due to the ARI: rhinorrhea, nasal congestion, pharyngitis, cough, difficult breathing or dyspnea, whatever occurs first. 7. Patient diagnosed with ARI can have associated complications such as but not limited to: acute exacerbation of asthma or chronic obstructive pulmonary disease, malignancy, hypoxemia, congestive heart failure, sepsis, septic shock, etc. 8. Patients with co-infections will not be excluded. However, patients identified with a Flu rapid assay as having flu will be excluded. Patients diagnosed with both RSV and Flu using the Idylla assay or PCR-based equivalent will not be excluded. 9. For participation to the assessment phase (just for inpatients) and to the remote monitoring phase (for inpatients and outpatients), patients will have a positive RSV test. Results of the RSV-PCR based test will be available within maximum 24h after screening for inpatients and within maximum 72h after screening for outpatients.
Exclusion criteria
Exclusion criteria: 1. Patient participates in another clinical study, with the exception of registry and epidemiology studies, involving minimum sampling done prior to the patient screening for the proposed study. 2. Patient is not able to provide informed consent prior to any study-related procedure(s), due to the mental status or severe clinical condition. 3. Patient has known dementia. 4. The onset of the acute respiratory symptoms was >7 days ago.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the viral load at screening (for inpatients and outpatients) and the rate of RSV viral clearance (for inpatients), based on the viral load measured in nasal samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the Clinical Symptom Score (CSS) based on clinical assessment | — |
Countries
Japan
Contacts
Public ContactHoutmeyers Els
J&J Janssen Infectious Diseases-Diagnostics BVBA
Outcome results
None listed