Respiratory syncytial virus (RSV) infection RSV
Conditions
Interventions
The investigator does not deliberately intervene in the consisting situation in order to study the effect of that intervention
nirsevimab will not be administered as part of the study. Nirsevimab is a recombinant neutralising human long-acting monoclonal antibody (product name: Beyfortus).
Sponsors
RIVM
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Children = 12 months of age, and; Presenting with clinical symptoms of lower respiratory tract infection (LRTI), defined as:LRT involvement, must have =1Clinical sign of severity, must have =1Rhonchi Rales Crackles WheezeIncreased respiratory rate* Hypoxemia† Acute hypoxic or ventilatory failure New-onset apnoea Nasal flaring Retractions GruntingDehydration owing to respiratory distress*=60 breaths/min for <2-month-old; =50 breaths/min for 2–6-month-old, =40 breaths/min for 6–24-month-old. † In room air O2<95%Informed consent obtained from parent(s) or legal guardian(s).Breakthrough casesRSV infection confirmed by a positive PCR in a respiratory sample (nasopharyngeal swab, nasopharyngeal aspirate or bronchoalveolar lavage), and;Receipt of nirsevimab immunization as part of the Dutch national immunization program.RSV controlsRSV infection confirmed by a positive PCR in a respiratory sample (nasopharyngeal swab, nasopharyngeal aspirate or bronchoalveolar lavage), and;No previous receipt of nirsevimab.Non-RSV LRTI controlsRSV infection ruled out by negative PCR in a respiratory sample (nasopharyngeal swab, nasopharyngeal aspirate or bronchoalveolar lavage), and;Receipt of nirsevimab immunization as part of the Dutch national immunization program.
Exclusion criteria
Exclusion criteria: Receipt of another monoclonal antibody (other than nirsevimab) or RSV vaccination of the mother during pregnancy;Aged =2 days, as the minimum incubation time for RSV infection is 3 days;Diagnosed with RSV infection =28 days prior to the current hospitalisation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum RSV pre-F IgG levels measured at the time of RSV diagnosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Levels of RSV-specific serum and mucosal IgA and IgG (pre-F, post-F, nucleoprotein), antibody functionality, RSV-PCR, RSV strain genome sequencing, and clinical characteristics/outcomes. | — |
Countries
Netherlands
Contacts
Public ContactD Smit
RIVM
Outcome results
None listed