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Table 2 Acute respiratory infections during follow-up, according to the randomization group

From: A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections

  Group A treatment, 3 months (n = 100) Group B placebo (n = 109) Group C treatment, 6 months (n = 37) p value
A vs B
p-value
A vs C
p-value
C vs B
Respiratory infections (any) n (%) n (%) n (%)    
 No 67 (32.0) 38 (34.9) 26 (70.3)    
 Yes 33 (33.0) 71 (65.1) 11 (29.7) < 0.0001 0.87 0.0003
AOM (any)
 No 76 (76.0) 60 (55.1) 28 (75.7)    
 Yes 24 (24.0) 49 (44.9) 9 (24.3) 0.002 0.85 0.04
Antibiotic prescription
 No 75 (75.0) 54 (49.5) 27 (73.0)    
 Yes 25 (25.0) 55 (50.5) 10 (27.0) 0.0002 0.98 0.02
Type of infection
 URTI, mean ± SD 0.33 ± 0.61 0.65 ± 0.55 0.29 ± 0.28 < 0.0001 0.85 0.0007
 Bacterial pharyngitis, mean ± SD 0.10 ± 0.55 0.14 ± 0.66 0.12 ± 0.49 0.88 0.91 0.93
 AOM, mean ± SD 0.24 ± 0.41 0.78 ± 0.73 0.25 ± 0.63 0.006 0.82 0.03
 Otorrhea, mean ± SD 0.16 ± 0.55 0.22 ± 0.64 0.19 ± 0.72 0.66 0.88 0.69
 Wheezing, mean ± SD 0.30 ± 0.63 0.27 ± 0.49 0.14 ± 0.54 0.78 0.06 0.08
Socioeconomic impact
 Days of absence from day-care, mean ± SD 4.49 ± 1.10 5.10 ± 1.33 4.33 ± 1.09 0.007 0.79 0.003
 Working days lost by parents, mean ± SD 1.76 ± 0.76 2.58 ± 0.73 1.88 ± 0.88 0.004 0.82 0.0004
  1. AOM: Acute otitis media; SD: standard deviation; URTI: upper respiratory tract infection; LRTI: lower respiratory tract infection