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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