Broncho-Vaxom/Ommunal (OM85)

Recurrent Respiratory Tract Infections (RRTI) in children are one of the most common conditions affecting paediatric patients with a significant impact both in term of morbidity, antibiotic usage, reduction in quality of life, as well as an increase in health care utilization. Recently, it has been shown that bacterial lysates, such as Broncho-Vaxom/Ommunal (OM85), are effective in preventing RRTI in children when taken orally, with an excellent tolerability profile. OM85 is an extract of 21 strains of 8 different bacteria, most commonly involved in respiratory infections (including Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis (viridans), Moraxella (Branhamella) catarrhalis).

The mechanism of action it is not completely clear as well as the role of OM85 in stimulating humoral and cellular immunity. Pre-clinical data indicated that OM85 stimulate the innate and adaptive immune response through the activation of dendritic cells, an increase in the Th1 response and an increase in secretory and serum IgA.
In Italy, Broncho-Vaxom/Ommunal is registered in adults and children above 1 year of age for the prophylaxis of RRTI. However, there are few data available on its use in the paediatric population.

The general practitioner and the family paediatrician (FPs) are generally responsible for the health care respiratory infections in children and only a few patients are referred to hospital. Using electronic data from a large population based network of FP (Pedianet) we aim to describe the prescription pattern of Broncho-Vaxom/Ommunal in Italian children.

In this retrospective, cohort, study all children aged less than 14 years, registered from 1st January 2007 to 30th June 2018, with one of the pediatricians who are collaborating with the continuous Pedianet data collection, and with at least one prescription of Ommunal or Broncho-Vaxom (ATC code J07AXxx) were included. The first OM-85 prescription is defined as index prescription.

RTI cases were defined as children having a visit claim with an upper respiratory tract infection or lower respiratory tract infection identified with International Classification of Diseases, 9th Revision, Clinical Modification code or a descriptive diagnosis in the free text field.