ROLE OF IMMUNOACTIVATION WITH PIDOTIMOD IN RECURRENT RESPIRATORY-INFECTIONS IN CHILDHOOD

The efficacy and safety of pidotimod 2-pyrrolidinyl)carbonyl]-thiazoli dine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) were rated in a child population with a remote history of recurrent respiratory infections (RRI). This randomized double-blind multicenter clinical trial versus placebo, stratified by age groups, involved 748 children recruited in 69 Medical Centres. The trial consisted of a 60-day treatment period a nd a 90-day follow-up. At the end of the treatment period the pidotimo d group showed a significant decrease in the number of RRI episodes an d associated symptoms vs control group. As a consequence, there was a significant decrease in the number of days of absence from kindergarte n or school and in the consumption of antibiotics and symptomatic drug s. Safety was good. The effect of the drug persisted after its withdra wal throughout the whole 90-day follow-up period. During this period t here was a significantly lower RRI incidence rate in the pidotimod gro up than in the placebo group (p < 0.01). Because of its efficacy and s afety, pidotimod may be rated as an excellent drug in the RRI manageme nt in children.