Multi-centre EuRopean study of Major Infectious Disease Syndromes

SLS and ARI are frequent causes of hospitalisation in infants and young
children, and pose a risk of severe outcomes and potentially also of long-term
complications. Both can be caused by pathogens with epidemic potential,
importantly EV and HPeV for SLS, and RSV, influenza virus, HRV, S. pneumoniae
for ARI. A better understanding of the role of these pathogens can inform
diagnostics, surveillance and management in this vulnerable age group as well
as prevention and outbreak response management.
The overall aim of this observational, case-control study is to prospectively
study the aetiology, diagnostics, clinical management, impact and outcomes
across Europe of:
1) Community acquired sepsis-like syndrome in infants (*6 months old) requiring
hospitalisation.
2) Community acquired acute respiratory tract infection in children (0-5 years
old) requiring hospitalisation.
The study will focus on specific pathogens known to be aetiological agents of
the two syndromes of interest (SLS and ARI). The study will also contribute to
capacity building within the paediatric PREPARE network aimed at establishing
early and robust European responses to (re-)emerging infections including rapid
identification, control and research responses.

1) To estimate the proportion of children aged * 6 months with sepsis-like
syndrome (SLS) which is attributable to Enterovirus (EV) or Human Parechovirus
(HPeV) infection.

2) To estimate the proportions of cases of ARI in children aged 0 to 5 years
old attributable to respiratory syncytial virus (RSV), influenza virus, human
rhinovirus (HRV) infection or S. pneumoniae.

prospective case-control study

Research samples will be collected with routine samples whenever possible to
minimise patient discomfort.
In addition to research samples, in some cases residuals of clinical samples
may be collected (e.g. CSF).

Any other microbiological samples taken as part of diagnostics and routine care
by the local clinical teams, including blood cultures, will be analysed locally
as per standard care and diagnostic work up. The results of these local tests
will also be recorded in the CRF.

Clinical observations, treatments and medical interventions will be recorded in
the CRF on admission (Day 0), and for cases until discharge, death or day 30 of
hospitalisation (whichever comes first).


Follow-up visits are not planned for most cases or controls, except for a
subgroup of 40 SLS cases who will be invited back for developmental assessments
at 12 months of age.