Effect of OM-85 in Reducing Pediatric Recurrent Respiratory Infections in a Real-World Setting
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Abstract
Introduction: Acute respiratory infections (ARI) represent an important health problem in the pediatric population. Possible preventive strategies include the use of bacterial lysates. The efficacy of the lyophilized bacterial extract OM-85 has been reported in several clinical studies, but little real-world data are available. Our objectives were to verify the effectiveness of OM-85 in reducing the number of visits for ARI and antibiotic use, and to compare the results in terms of recurrent respiratory infections (rRTI: ≥ 6/year) with a control cohort.
Methods: From a database of 13229 pediatric patients, 108 children treated with 3 complete cycles of OM-85 were identified. By stratified sampling, a control group with similar baseline characteristics was formed.
Results: The median number of visits for ARI was significantly reduced from 5 (interquartile range [IQR]: 2.75-7) before OM-85 administration to 1 visit (IQR: 0-2), independent of sex, age group or exclusive breastfeeding (EBF). The number of courses of antibiotics was significantly reduced from 1.63/patient to 0.71/patient, independent of sex, age or history of EBF. The prevalence of rRTI was significantly reduced from 39.81% to 4.62%, while it remained stable in the control cohort (48.14%).
Conclusion: In real pediatric practice settings in Peru, OM-85 was associated with reduced incidence of ARI, antibiotic use and rate of patients with recurrent ARI. The reduction of rRTI rate in this population is especially highlighted.
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