IMMUNOSTIMULATION
WITH OM-85 IN CHILDREN SUFFERING FROM RECURRENT URTIS: A DOUBLE-BLIND,
PLACEBO-CONTROLLED, MULTICENTRE STUDY
Urs B. Schaad
Universitäts-Kinderspital beider Basel (UKBB)
Basel, Switzerland
Background: Community acquired infections of
the upper respiratory track (URTI) are very important in young children.
For example, half of the Paediatric consultation in Switzerland are due to
upper respiratory tract infections. Whereas most of the infections are
caused by viruses, the prescription of antibiotics is very high due to the
large incidence of secondary bacterial infection.
Methods: This is a randomized,
double-blind, placebo-controlled, multicenter study with OM-85 in 232
patients aged 36 to 96 months, suffering from recurrent URTIs. URTI was
defined by the presence of at least two of the following symptoms :
rhinitis, pharyngitis, cough, hoarseness, fever > 38.5°C or URTI-related prescription of an
antibiotic.
Results: OM-85 treated patients had a
lower rate of URTIs (p=0.05). The cumulated difference between URTIs
reached –0.4 URTIs per patient in 5 months. The largest reduction was in
the patients having had ³ 3 URTIs during the study
period; odds ratios for ³ 3 URTIs were 0.51 (95% C.I.:
0.29-0.91) and 0.65 (0.37-1.11) after 5 and 6 months, respectively. The
difference between OM-85 and placebo was independent of age but was more
important in patients reporting a larger number of URTIs in the previous
year. Patients’ global assessment showed improvement in comparison to the
previous season in the majority of cases (OM-85: 78.4% of cases; placebo:
75.5%); however, there were more cases reporting worsening with placebo
(6.4% vs. 0.9%; p = 0.05).
Conclusions: OM-85 significantly reduced the
frequency of URTIs, particularly in children with a history of frequent
URTIs. Safety and tolerance of test medication were good, comparable to
placebo.