Abstract
Background: In Italy, the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®) is registered for the prophylaxis of recurrent respiratory tract infections (RTIs) in adults and children above one year of age, but there are limited data on its use in the paediatric population. We aim to estimate the impact of OM-85 treatment on RTIs and antibiotic prescriptions in children. Methods: This study included children aged 1 to 14 years enrolled in Pedianet, a paediatric general practice research database, from January 2007 to June 2017, having at least one prescription of OM-85. Children with less than 12 months of follow-up before (PRE period) and after (POST period) the OM-85 prescription were excluded. The frequency of antibiotic prescriptions and the frequency of RTI episodes in the PRE and POST periods were compared through the post-hoc test. Subgroup analysis was performed in children with recurrent RTIs. Results: 1091 children received 1382 OM-85 prescriptions for a total follow-up of 619,525.5 person-years. Overall, antibiotic prescriptions decreased from a mean of 2.8 (SD (standard deviation) 2.7) prescriptions in the PRE period to a mean of 2.2 (SD 2.6) prescriptions in the POST period (p < 0.0001). RTIs decreased from a mean of 3.4 (SD 2.9) episodes in the PRE period to a mean of 2.5 (SD 2.6) episodes in the POST period (p < 0.0001). No change in antibiotic class was noted, and co-amoxiclav remained the preferred therapy in 28% of cases, followed by amoxicillin. These results were confirmed among children with recurrent RTIs. Conclusions: OM-85 is effective in preventing both antibiotic prescriptions and RTIs in children.
Highlights
In Italy, the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral® ) is registered for the prophylaxis of recurrent respiratory tract infections (RTIs) in adults and children above one year of age, but there are limited data on its use in the paediatric population
Different studies investigating bacterial lysates, such as OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral® ), have shown their efficacy in the prevention of recurrent RTIs in children when taken orally, showing a decreased risk of respiratory tract infection ranging from 16% to 40%, with an excellent tolerability profile [2,3,4]
Within the framework of the Italian National Healthcare System, every child is registered at birth and receives medical care, free of charge, from one of the approximately 7000 family paediatrician (FP) who work for the Italian National Healthcare System
Summary
In Italy, the bacterial lysate OM-85 (Broncho-Vaxom® , Broncho-Munal® , Ommunal® , Paxoral® , Vaxoral® ) is registered for the prophylaxis of recurrent respiratory tract infections (RTIs) in adults and children above one year of age, but there are limited data on its use in the paediatric population. No change in antibiotic class was noted, and co-amoxiclav remained the preferred therapy in 28% of cases, followed by amoxicillin These results were confirmed among children with recurrent RTIs. Conclusions: OM-85 is effective in preventing both antibiotic prescriptions and RTIs in children. (Broncho-Vaxom® , Broncho-Munal® , Ommunal® , Paxoral® , Vaxoral® ), have shown their efficacy in the prevention of recurrent RTIs in children when taken orally, showing a decreased risk of respiratory tract infection ranging from 16% to 40%, with an excellent tolerability profile [2,3,4].
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