An open labelled prospective clinical study to evaluate the efficacy, safety and cost analysis of Pidotimod as add-on drug for maintenance therapy in Paediatric Recurrent Acute Respiratory tract Infections

Abstract

Recurrent Acute Respiratory Tract Infections (ARTI) are the commonest form of infections affecting children irrespective of socioeconomic status and geographical limits. Immaturity of immune response involving neutrophils, NK cells, T and B cells, in the early childhood, is often cited as a reason for this RRTI. There is comparatively high incidence of ARTI in South East Asian countries when compared to global statistics. The possibility of using immune stimulation as a method of reducing the recurrence of ARTI prompted the use of Pidotimod as add-on drug. We tried to explore the safety, efficacy and cost benefit analysis of Pidotimod as add-on treatment for paediatric use. After registering for Clinical trial and getting IEC approval, we started an open labelled prospective single arm interventional study by recruiting 65 children between 2-12 years with ARTI to receive 800 mg daily for 15 days and 400 mg for 45 days and was followed up for 6 months. Study revealed a significant reduction in number and duration of RRTI as well as reduction in episodes requiring antibiotics and reduction in duration of treatment. The reduction in number of school days lost and treatment expenses were statistically significant. There was a significant increase in mean absolute count in CD45, CD3, CD4, CD8 and lymphocyte counts at 6 months follow-up. Hence, we conclude that 60day Pidotimod therapy has immune stimulatory activity preventing the RRTI in paediatric population when considered as an add-on therapy to standard treatment.