Journal of Chemotherapy Vol. 11 - n. 2 (126-130) - 1999 © E.I.F.T. srl - Firenze ISSN 1120-009X INTRODUCTION It is well known that Down’s syndrome (tri- somy 21, DS) is associated with enhanced suscep- tibility to viral and bacterial infections (see 1-2 for reviews). In particular, recurrent upper respiratory tract infections are one of the major causes of morbidity in children with DS, and require multi- Prophylaxis with the Novel Immunomodulator Pidotimod Reduces the Frequency and Severity of Upper Respiratory Tract Infections in Children with Down’s Syndrome I. LA MANTIA 1 - C. GRILLO 1 - T. MATTINA 2 - P. ZACCONE 3 - M. XIANG 3 M. DI MAURO 4 - P.L. MERONI 5 - F. NICOLETTI 6 1 Ear, Nose and Throat Department Clinic, University of Catania; 2 Pediatric Clinic, University of Catania; 3 Institute of Microbiology, University of Catania; 4 Institute of Internal Medicine, University of Catania, Italy. 5 Department of Internal Medicine, Policlinico, IRCCS, Milan; 6 Institute of Microbiology, University of Milan, Italy. Correspondence: Ferdinando Nicoletti, MD, Via Luigi Sturzo n.3, 95021, Cannizzaro, Catania, Italy. Tel: +39-0347- 3369125; Fax: +39-095-325032. E-mail: ferdinic@ctonline.it Summary Down’s syndrome (DS) is associated with several defects of both specific and non-specific immunity which may explain the enhanced susceptibility of DS subjects to viral and bacterial infections. In this study we have evaluated the effects of the new synthetic immunomodulator pidotimod in recurrent infec- tions of the upper respiratory tract in a group of children with DS. It was an open trial vs untreated control, the pidotimod-treated group consisted of 14 subjects and the control group of 12. Pidotimod was administered at the dose of one 400 mg oral bottle/day for 90 days. There was a significant reduction in the frequency, severity and duration of infectious episodes in the pidotimod- treated group vs the untreated control group. The beneficial effects of pidoti- mod were also confirmed by a series of recordings made over the 90-day treat- ment period which showed a significant reduction in the number of days of fever, severity of the signs and symptoms of the acute episodes and use of antibiotics and antipyretic drugs. Pidotimod was well tolerated and no clinical, hematological or biochemical side-effects were noted. Key words: Down’s syndrome, respiratory tract infection, immunomodula- tor, pidotimod. REPRINT