Summary

Information on the frequency of viral infections causing responsible for AGE presenting at the primary health care level is sparse, mostly because of the absence of routine screening and reporting for these infections. With the availability of an effective vaccine for RV, studies for current RV disease burden are needed to describe and demonstrate the burden of the disease, seasonal fluctuations and raise awareness among the public health practitioners and health authorities. Italy is a country with a low RV vaccination coverage, therefore still an ideal setting to carry out studies on the burden of RV and other virus GE. To evaluate the burden of viral gastroenteritis (including RV, Norovirus and Adenovirus) in different age groups and its cost we performed a prospective cohort study using the Pedianet network of Family Paediatricians. 

It was performed an observational, prospective, family paediatrician-based study. All children <5 years of age from the defined population who presented at the selected FP sites with AGE (defined as the occurrence of three or more looser than normal stools within a 24-hour period and/or at least one forceful vomiting (excluding post-tussive vomiting) that is not explained by an underlying medical condition) were eligible to be included in the study. Their parents/guardians were asked to consent to participate and to have a stool sample collected and tested. 

The presence of adenovirus, norovirus and rotavirus nucleic acids in stools samples were analysed by real-time PCR (adenovirus and norovirus) or end-point RT-PCR (rotavirus). 
Surveillance was conducted for 12 months (including a full RV season) to assess disease incidence rates, disease age distribution, disease severity, seasonal variations in disease burden, and costs of viral AGE. The study started in May 2010 and will last for 12 months. 

Different endpoints were assessed. As primary objective was estimated the incidence of RVGE leading to a FP visit among children <5 years of age in a well-defined Italian population. As secondary objectives there were different point: 

· To estimate the incidence of Norovirus and Adenovirus GE leading to a FP visit among children <5 years of age in a well-defined Italian population. 
· To determine the age of the children, disease severity, and the seasonal distribution of RV, Norovirus and Adenovirus GE among children <5 years of age. 
· To compare the outcomes in RV, Norovirus and Adenovirus positive and negative children with AGE. 
· To estimate the medical and societal costs due to RV, Norovirus and Adenovirus GE on GP practice and families.

Partecipants and Collaborations

Partecipants

Principal Investigator
Dr Carlo Giaquinto 
Department of Paediatrics 

Pedianet coordinator
Dr Luigi Cantarutti 
SoSeTe - Pedianet 

Head Epidemiologist
Prof Miriam Sturkenboom 
Department of Epidemiology and Biostatistics and Medical informatics 
Erasmus University Medical Center, Rotterdam 

Collaborations

Laboratory
Virology laboratory of the Department of Microbiology 
Prof Luisa Barzon 
University of Padova. 


Financial support
Sanofi-Pasteur MSD 
Géraldine Dominiak-Felden

Pubblications