| |
Control group
|
Intervention group
|
p
|
|---|
|
ITT = PP
|
ITT
|
PP
|
Control vs ITT
|
Control vs PP
|
|---|
|
n = 237
|
n = 133
|
n = 81
| | |
|---|
|
Age in years; median, (IQR)
|
60 (30)
|
61 (34)
|
71 (26)
|
ns
|
<0,01
|
|
Sex – female
|
148 (62)
|
74 (56)
|
33 (41)
|
ns
|
<0,01
|
|
Febrile uncomplicated UTI
|
54 (23)
|
30 (23)
|
9 (11)
|
ns
|
0,02
|
|
Antimicrobial treatment at inclusion
|
90 (38)a
|
44 (33)
|
22 (27)
|
ns
|
ns
|
|
Urologic history
|
|
Present urinary catheter
|
17 (7)
|
9 (7)
|
8 (10)
|
ns
|
ns
|
|
History of urinary tract disordera
|
73 (31)
|
33 (25)
|
29 (36)
|
ns
|
ns
|
|
Recurrent UTIb
|
30 (13)c
|
11 (9)c
|
5 (7)
|
ns
|
ns
|
|
Comorbidity
|
|
Any
|
124 (52)
|
77 (58)
|
57 (70)
|
ns
|
<0,01
|
|
Diabetes mellitus
|
36 (15)
|
29 (22)
|
25 (31)
|
ns
|
<0,01
|
|
Malignancy
|
13 (5)
|
11 (8)
|
10 (12)
|
ns
|
ns
|
|
Heart failure
|
32 (13)
|
12 (9)
|
11 (14)
|
ns
|
ns
|
|
Cerebrovascular disease
|
17 (7)
|
20 (15)
|
18 (22)
|
0.02
|
<0,01
|
|
Cirrhosis
|
1 (0)
|
2 (1)
|
1 (1)
|
ns
|
ns
|
|
Renal insufficiency
|
12 (5)
|
20 (15)
|
18 (22)
|
<0.01
|
<0,01
|
|
Immunocompromised
|
19 (8)
|
10 (8)
|
5 (6)
|
ns
|
ns
|
- Data are presented as n (%) unless otherwise stated. ITT intention to treat analysis, PP per protocol analysis, IQR interquartile range, ns not significant (at 0,05 level), UTI urinary tract infection. aUrinary tract disorder: presence of any functional or anatomical abnormality of the urinary tract excluding the presence of a urinary catheter. bRecurrent UTI: two or more episodes in the last 6 months or three or more episodes of UTI in the last year. cUTI history was unknown in 13 subjects in control period and 6 subjects in intervention period
