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

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

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


Affecting practically 500,000 youngsters underneath the age of two in France every year, 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 examine, 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. Due to the PEDSTART community labeled F-CRIN, requested by the SANOFI laboratory (promoter), HARMONIE plans to incorporate 30,000 members in whole, together with no less than 7,000 in France, in hospitals and pediatric practices.


Bronchiolitis is a respiratory assault within the bronchioles of infants, attributable to 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 youngsters underneath the age of two in France every year, results in 30,000 emergency room consultations, together with 10,000 circumstances of hospitalization on account of respiratory and consuming difficulties. It’s estimated that the majority youngsters underneath 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 baby will proceed to cough for the next 3-4 weeks. In essentially the most severe circumstances, some youngsters maintain respiratory sequelae.


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


This month, a brand new large-scale examine, the biggest examine ever carried out in Europe, will begin in France, Germany and the UK: HARMONIE. This examine 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 in opposition to RSV lies in the truth that it’s injected intramuscularly, with a single injection to cowl the whole epidemic season. HARMONIE plans to recruit 30,000 members from France, Germany and the UK. It follows the profitable MELODY examine, wherein practically 1,500 infants participated.
Due to the sector experience and responsiveness of PEDSTART (INSERM community labeled F-CRIN), requested by the SANOFI laboratory (promoter), and its connections in Europe, no less than 7,000 sufferers can be recruited in France for this examine. PEDSTART plans not solely to contain the hospitals in its community but additionally non-public 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 examine 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 way of this randomized examine, we hope to show the effectiveness of Nirsevimab on RSV and meet a large want for prevention. The time constraints being quick to cowl the 2022 epidemic season, the responsiveness of our community was important. The particularity of this examine is that it takes place on a big scale on the territory, each in hospital constructions and in non-public pediatric practices. We invite households who wish to take part within the examine to contact their pediatrician.

Analysis can also be underway to develop a vaccine that may be administered to the mom on the finish of being pregnant and particular healing remedies, which at present 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 baby internationally. This community devoted to pediatric scientific analysis brings collectively all specialties and considerations 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 tutorial and industrial companions from 19 totally different nations. . 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 corporation of excellence serving French scientific analysis. Its purpose is to strengthen the competitiveness of French scientific analysis internationally, to determine and label analysis networks, to facilitate the organising of educational or industrial scientific trials, and to develop the experience of actors within the scientific analysis, by pooling know-how, aims and assets. The group, which has a nationwide coordination unit situated in Toulouse, has already labeled and at present federates 12 scientific investigation networks concentrating on ailments of common 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 help platform providing all of the companies mandatory for the conduct of scientific trials. In whole, F-CRIN represents a strike power of greater than 1,400 professionals in scientific analysis. F-CRIN advantages from the help of the ANR, the CHU of Toulouse and the College “Paul Sabatier” Toulouse III. For extra info :


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