title: Efficacy and safety of ribosome-component immune modulator for preventing recurrent respiratory infections in socialized children.
abstract: Attending day care is associated with recurrent respiratory infections (RRIs) and asthma. Ribosomal immunotherapy may confer protection against RRIs in children. This study was designed to assess the efficacy of a ribosome-component immune modulator (RCIM) as preventive treatment of respiratory infections in socialized children aged ≤5 years, with or without a history of frequent RRI. In a multicenter, Italian, randomized, double-blind, placebo-controlled, parallel-group study, 164 socialized day care center children (mean age, 3.8 ± 1.1 years) were treated with RCIM or placebo for 6 months and followed-up for additional 6 months. Outcomes are presented for the intent-to-treat population. In socialized children with five or less RRIs (n = 95; 49 RCIM and 46 placebo, group A) the duration of the infectious episodes was significantly shorter with RCIM than with placebo (6 months, 3.7 ± 2.1 versus 4.5 ± 1.9 days, p = 0.040; 12 months, 3.6 ± 2.0 versus 4.7 ± 2.5 days, p = 0.015). The proportion of patients reporting no respiratory infectious episodes with RCIM at 6 and 12 months was also significantly larger in group A (20.4% versus 4.4% placebo; p = 0.028). No such differences were found in children with more than five RRIs in the preceding year (n = 63; 32 RCIM and 31 placebo, group B). In all children, general well-being improved significantly more under RCIM than under placebo (11.6 ± 1.8% versus 10.2 ± 1.8%; p = 0.002). No statistically significant between-treatment differences were observed for other end points. Both treatments were similarly well tolerated. Six-month treatment with RCIM effectively prevented the 12-month risk of RRIs in children <5 years old and with five or less RRIs in the preceding year.
authors.affiliation: Department of Child and Maternal Medicine, Fatebenefratelli/Melloni University Hospital, Milan, Italy. allerg@tin.it
authors.forename: Alessandro
authors.initials: A
authors.lastname: Fiocchi
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.forename: Renzo
authors.initials: R
authors.lastname: Mora
authors.forename: Alberto
authors.initials: A
authors.lastname: Macchi
authors.forename: Luigi
authors.initials: L
authors.lastname: Nespoli
authors.forename: Sergio
authors.initials: S
authors.lastname: Arrigoni
authors.forename: Luca
authors.initials: L
authors.lastname: Guastini
authors.forename: Paolo
authors.initials: P
authors.lastname: Castelnuovo
authors.forename: Daniela
authors.initials: D
authors.lastname: Graziani
authors.forename: Sergio
authors.initials: S
authors.lastname: Marcassa
mesh_terms: D000942:Antigens, Bacterial / Q000627:therapeutic use*; D002656:Child Day Care Centers; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007558:Italy; D008297:Male; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D000942:Antigens, Bacterial; D007155:Immunologic Factors; C034206:Ribomunyl