Effectiveness and safety of pidotimod in recurrent respiratory infections in children: a pilot study

ABSTRACT

Background: Recurrent respiratory infections (RRIs) are common in children especially in age 1 to 6 years. Pidotimod, an immunostimulant has been found to lower the recurrences of RRIs and improve the quality of life. The Objective of this study was to assess the efficacy and safety of pidotimod in children with recurrent respiratory infections (RRIs).Methods: In this single-centre, prospective, observational study, children aged 2 to 15 years diagnosed with RRIs were included. RRIs were defined as occurrence of 3 or more episodes of acute respiratory infections (ARIs) or more than 15 days of respiratory symptoms in the past 3 months. These children were treated with pidotimod in addition to standard care treatment. Treatment duration was two months and the follow-up continued for three months. Number of RRIs and severity of RRIs, antibiotic courses and rate of hospitalization before and after treatment were compared.Results: In total 25 children included in the study, mean age was 7.34'3.63 years. Among them, 68% were males. After treatment with pidotimod, there was significant reduction in mean number of ARI episodes (3.84'0.85 at baseline to 0.48'0.51 at follow-up, p<0.0001). Also, there was significant reduction in the duration of acute infectious episodes (p<0.0001), need of antibiotic courses (p<0.0001) and rates of hospitalization (p<0.0001). No safety concerns were identified and pidotimod was well tolerated.Conclusions: Addition of pidotimod to the standard treatment in children with RRIs significantly reduces the recurrence, duration of repeat infectious episodes, need of antibiotic treatments and future rates of hospitalizations. These findings support previous data.