Efficacy of a polyvalent bacterial lysate in children with recurrent respiratory tract infections.
Respiratory tract infections (RTIs) are the most frequent infections in humans, particularly in children. In addition to intervention, increasing interest is focusing on immunomodulatory therapy for recurrent RTIs, which indicate a reduced defense capacity of the respiratory mucosa. LW 50020, an oral immunomodulator that contains the antigens of seven bacteria common in RTIs, has reduced the number, duration, and severity of RTIs in children and adults. This 56-week placebo-controlled, double-blind study in 188 children investigated whether the efficacy of the standard schedule (immunization cycle + one booster cycle) would be enhanced by additional booster cycles. Efficacy and safety over the long term were also assessed. The rate of infection was reduced by 50% with the standard schedule and could not be further decreased by two consecutive booster cycles. With both schedules, this reduction was sustained during a 28-week treatment-free observation period that followed the 28-week treatment period. The number of adverse drug reactions was low, and all were transient, expected, and nonserious. These results confirm that LW 50020 is an effective and safe strategy for RTIs.
Ruah
S B
SB
Universidade Nova, Lisbon, Portugal.
Ruah
C
C
van Aubel
A
A
Abel
S
S
Elsasser
U
U
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000284:Administration, Oral; D001428:Bacterial Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011336:Probability; D011446:Prospective Studies; D012008:Recurrence; D012016:Reference Values; D012141:Respiratory Tract Infections / Q000175:diagnosis / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D001428:Bacterial Vaccines; C078795:LW 50020