THERAPEUTIC EFFICACY AND SAFETY OF PIDOTIMOD IN THE TREATMENT OF URINARY-TRACT INFECTIONS IN CHILDREN

The activity of pidotimod 2-pyrrolidinyl)carbonyl]-thiazolidine-4-carb oxylic acid, PGT/1A, CAS 121808-62-6) was studied vs. placebo in a dou ble-blind, randomized, multicentre trial, involving 60 pediatric patie nts with recurrent urinary tract infections. Recovery from acute event s was quicker with pidotimod than with placebo (9.6 vs. 12.3 days). In treated patients antibiotic therapy was shorter (6.9 vs. 8.3 days) an d main symptomatic parameters (body temperature, vesical tenesmus, str anguria, pollakiuria, total number of symptoms, total symptomatic inte nsity, rate of asymptomatic patients, haematuria, leukocyturia, positi ve urinary culture) receded quickly. In patients receiving the drug as well as in patients treated with placebo changes in laboratory parame ters were observed, indicating recovery from the acute infectious dise ase. A significant trend to normalization of the immune response, expr essed by chemotaxis and index of leukocyte phagocytosis, was found onl y in patients treated with pidotimod. After the acute episode a signif icant decrease of risk of relapses (69%) was observed in these patient s. If a relapse occurs, the response of treated patients is quicker (d uration of fever, total time of relapses) than for control patients. T hese findings allow to correlate the individual immune response activa tion to the resistance to recurrent infections and also to a better re sponse to therapy if the disease occurs and becomes clinically relevan t. No side effects were observed. Mild reactions (4 nausealvomiting, 1 erythema) occurred only in 5 patients (2 pidotimod, 3 placebo) but we re attributed to concomitant antibiotic therapy. No alterations of mai n laboratory parameters were found. These findings confirm the tolerab ility of the drug also in long-term treatment. In conclusion, in the m ajority of patients with recurrent urinary tract infections pidotimod induces a partial stimulation of immune response that allows to signif icantly reduce the duration and intensity of acute events and future r isk of relapses, maintaining the positive effects observed during the treatment of acute events also in case of clinically relevant relapses , without signs of clinical or biological intolerance.