EFFICACY AND SAFETY OF PIDOTIMOD IN THE TREATMENT OF RECURRENT RESPIRATORY-INFECTIONS IN CHILDREN

The activity of pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl] -thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) was evaluate d in a double-blind, placebo-controlled, randomized, multicentre trial , on 120 pediatric patients affected by recurrent respiratory infectio ns. The clinical course of acute infections was favourable both in pla cebo and in treatment group, but recovery was quicker with pidotimod t han with placebo. Antibiotic therapy and time of hospitalization were shorter in the patients taking pidotimod, and main symptomatic paramet ers (pharyngalgia, dysphagia, mucous membrane inflammation, adenopathy , anorexia) receded quickly. In patients receiving the drug as well as in placebo group changes in laboratory parameters, indicating recover y from the acute infectious events, were observed. A significant trend to normalization of the immune response, evidenced by chemotaxis and leukocyte phagocytosis index, was found only in patients treated with pidotimod. A significant decrease in the risk of relapses was observed in patients treated with pidotimod (35%), as well as a reduction of h ospitalization (86%) and a decreased antibiotic therapy (47%). If a re lapse occurred, the response of treated patients was quicker (fever, a ntibiotic therapy, hospitalization). These findings allow to correlate the individual immune response activation to the resistance to recurr ent infections and also to a better response to therapy in case of cli nically relevant disease. No side effects were observed. Only in 12 pa tients (5 pidotimod, 7 placebo) mild reactions were observed, but they were attributed to concomitant antibiotic treatment or other factors. No alterations in main laboratory parameters were seen. These finding s confirm the safety of pidotimod also in long-term treatment. In conc lusion, in the majority of pediatric patients suffering from recurrent respiratory infections, pidotimod induces an at least partial stimula tion of immune response, significantly reducing duration and severity of acute events and the risk of relapses, maintaining the favourable e ffects observed during the treatment of acute events also in cases of clinically relevant relapses, with no signs of clinical or biological intolerance.