Respiratory Syncytial Virus Consortium in Europe (RESCEU) Birth Cohort Study: Defining the Burden of Infant Respiratory Syncytial Virus Disease in Europe
Joanne Wildenbeest, Roy Zuurbier, Koos Korsten, Marlies A. van Houten, Marie N Billard, Nicole Derksen-Lazet, Matthew D. Snape, Simon B. Drysdale, Hannah Robinson, Andrew J. Pollard, Terho Heikkinen, Steve Cunningham, Amanda Leach, Federico Martinón-Torres, Carmen Rodríguez-Tenreiro Sánchez, Alberto Gómez-Carballa, Louis Bont, RESCEU Investigators, Joanne Wildenbeest, Roy Zuurbier, Koos Korsten, Marlies van Houten, Marie Billard, Nicole Derksen-Lazet, Louis Bont, Simon B. Drysdale, Matthew Snape, Hannah Robinson, Andrew J. Pollard, Federico Martinón-Torres, Carmen Rodríguez-Tenreiro Sánchez, Alberto Gómez-Carballa, Terho Heikkinen, Steve Cunningham, Harish Nair, Harry Campbell, Amanda Leach, Peter Openshaw, Philippe Beutels, Eva Molero, Adam Meijer, Elisabeth Sanders, Thea Kølsen Fischer, Maarten van den Berge, Carlo Giaquinto, Mark Esser, Charles Knirsch, Scott Gallichan, Jeroen Aerssens, Brian Rosen, Joanne Wildenbeest, Roy Zuurbier, Koos Korsten, Marlies van Houten, Marie Billard, Nicole Derksen-Lazet, Louis Bont, Simon B. Drysdale, Matthew Snape, Hannah Robinson, Andrew J. Pollard, Federico Martinón‐Torres, Carmen Rodríguez-Tenreiro Sánchez, Alberto Gómez‐Carballa, Terho Heikkinen, Steve Cunningham, Harish Nair, Harry Campbell, Amanda Leach, Peter Openshaw, Philippe Beutels, Eva Molero, Adam Meijer, Elisabeth Sanders, Thea Kølsen Fischer, Maarten van den Berge, Carlo Giaquinto, Mark Esser, Charles Knirsch, Scott Gallichan, Jeroen Aerssens, Brian Rosen
Abstract
BACKGROUND: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in infants worldwide. Although prematurity and cardiopulmonary disease are risk factors for severe disease, the majority of infants hospitalized with RSV are previously healthy. Various vaccines and therapeutics are under development and expected to be available in the near future. To inform the use of these new vaccines and therapeutics, it is necessary to determine the burden of RSV disease in Europe. We will prospectively follow-up a birth cohort to obtain incidence data on RSV acute respiratory tract infection (ARTI). METHODS: Multicenter prospective study of a birth cohort consisting of 10 000 healthy infants, recruited during 3 consecutive years. RSV associated hospitalization in the first year of life will be determined by questionnaires and hospital chart reviews. A nested cohort of 1000 infants will be actively followed. In case of ARTI, a respiratory sample will be collected for RSV molecular diagnosis. RESULTS: The primary outcome is the incidence rate of RSV-associated hospitalization in the first year of life. In the active cohort the primary outcome is RSV associated ARTI and MA-ARTI. CONCLUSIONS: We will provide key information to fill the gaps in knowledge about the burden of RSV disease in healthy infants. CLINICAL TRIALS REGISTRATION: NCT03627572.