BRONCHIOLITIS: Because the season is about to begin, the hope of an efficient preventive therapy with a novel research in Europe

BRONCHIOLITIS: Because the season is about to begin, the hope of an efficient preventive therapy with a novel research in Europe

This month, a brand new large-scale research, the biggest research ever carried out in Europe, will begin in France…


Affecting practically 500,000 kids below the age of two in France annually, bronchiolitis results in the hospitalization of 10,000 infants. Right now there is just one preventive therapy, very restrictive and administered solely to essentially the most fragile infants (Palivizumab). However a brand new research, distinctive in Europe, HARMONIE, beginning in September, goals to check the effectiveness of a brand new monoclonal antibody (Nirsevimab), which might enable the final vaccination of infants. Because of the PEDSTART community labeled F-CRIN, requested by the SANOFI laboratory (promoter), HARMONIE plans to incorporate 30,000 contributors in whole, together with not less than 7,000 in France, in hospitals and pediatric practices.


Bronchiolitis is a respiratory assault within the bronchioles of infants, brought on by a number of viruses together with RSV (Respiratory Syncitial Virus), a winter virus beginning in France round mid-October and lasting till February. Bronchiolitis impacts 500,000 kids below the age of two in France annually, results in 30,000 emergency room consultations, together with 10,000 circumstances of hospitalization attributable to respiratory and consuming difficulties. It’s estimated that the majority kids below the age of two will encounter RSV, and that 30% of them will develop bronchiolitis. The acute episode lasts on common one week however the little one will proceed to cough for the next 3-4 weeks. In essentially the most severe circumstances, some kids maintain respiratory sequelae.


Right now, there isn’t any treatment for sufferers with bronchiolitis; simply symptomatic therapy (nostril washes, fractionation of meals, even oxygen remedy in hospitalization) and preventive therapy: Palivizumab, (monoclonal antibody directed towards RSV), which is just administered to sufferers most in danger (very untimely infants , infants with important coronary heart illness, and so forth.). This can be a notably restrictive therapy which should be injected intramuscularly each 4 weeks through the epidemic season. Barrier gestures (washing palms, sporting a masks, airing rooms, cleansing surfaces, and so forth.) are an efficient solution to restrict the unfold of the virus.


This month, a brand new large-scale research, the biggest research ever carried out in Europe, will begin in France, Germany and the UK: HARMONIE. This research goals to check the effectiveness of a brand new antibody, Nirsevimab, in decreasing hospitalizations for RSV bronchiolitis. The benefit of this new monoclonal antibody directed towards RSV lies in the truth that it’s injected intramuscularly, with a single injection to cowl the complete epidemic season. HARMONIE plans to recruit 30,000 contributors from France, Germany and the UK. It follows the profitable MELODY research, wherein practically 1,500 infants participated.
Because of the sphere experience and responsiveness of PEDSTART (INSERM community labeled F-CRIN), requested by the SANOFI laboratory (promoter), and its connections in Europe, not less than 7,000 sufferers will likely be recruited in France for this research. PEDSTART plans not solely to contain the hospitals in its community but additionally personal pediatric practices by way of the French Affiliation of Ambulatory Pediatrics (AFPA), the Toddler Medical and Therapeutic Affiliation of Val de Marne (ACTIV), of the French Society of Pediatrics (SFP) and the French Society of Neonatology (SFN).

“By no means has a research of this magnitude taken place within the pediatric world in France, this can be a first”
explains Dr FLAMEIN, Pediatrician Hospital Practitioner on the Lille College Hospital and spokesperson for PEDSTART (F-CRIN) on the topic. “By this randomized research, we hope to show the effectiveness of Nirsevimab on RSV and meet an enormous want for prevention. The time constraints being brief to cowl the 2022 epidemic season, the responsiveness of our community was important. The particularity of this research is that it takes place on a big scale on the territory, each in hospital buildings and in personal pediatric practices. We invite households who want to take part within the research to contact their pediatrician.

Analysis can be underway to develop a vaccine that may be administered to the mom on the finish of being pregnant and particular healing remedies, which presently don’t exist.

Labeled F-CRIN, coordinated by Prs Régis HANKARD (CHU of Excursions,) and Frédéric GOTTRAND CHRU of Lille), PEDSTART is a nationwide community of excellence in scientific analysis in pediatrics, responding to the necessity to promote analysis in little one internationally. This community devoted to pediatric scientific analysis brings collectively all specialties and issues all ages, from untimely infants to adolescents. Single level of contact in France for investigators and sponsors of pediatric scientific trials, PEDSTART is the gateway to France for a European pediatric scientific analysis community, Conect4Children, which brings collectively 43 educational and industrial companions from 19 completely different international locations. . For extra info : and

About F-CRIN

Created in 2012, supported by INSERM and funded by the ANR and the Ministry of Well being, F-CRIN (French Medical Analysis Infrastructure Community) is a company of excellence serving French scientific analysis. Its intention is to strengthen the competitiveness of French scientific analysis internationally, to determine and label analysis networks, to facilitate the establishing of educational or industrial scientific trials, and to develop the experience of actors within the scientific analysis, by pooling know-how, goals and sources. The group, which has a nationwide coordination unit situated in Toulouse, has already labeled and presently federates 12 scientific investigation networks concentrating on illnesses of normal worldwide curiosity (Parkinson, Extreme Bronchial asthma, Thrombosis, Weight problems, Cardio-nephrology , A number of Sclerosis, Retinal Ailments, Autoimmune Ailments, Vaccinology, Cardiology), 3 networks of experience and methodology (Uncommon Ailments, Medical Gadgets, Epidemiology) and a tailored assist platform providing all of the providers essential for the conduct of scientific trials. In whole, F-CRIN represents a strike drive of greater than 1,400 professionals in scientific analysis. F-CRIN advantages from the assist of the ANR, the CHU of Toulouse and the College “Paul Sabatier” Toulouse III. For extra info :


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