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Table 6 Confirmed P. aeruginosa infections up to day 90 (overall and stratified by time period for first time of onset) (ITT population)

From: A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients

Culture typea

Time period

IC43 100 μg with adj

IC43 100 μg w/o adj

IC43 200 μg with adj

Placebo

Overall

  

N = 104

N = 98

N = 101

N = 98

P valueb

  

n (%)

N’

n (%)

N’

n (%)

N’

n (%)

N’

 

Invasive

Overall

14 (13.5)

104

11 (11.2)

98

14 (14.0)

100

6 (6.1)

98

0.2533

infectionc

Day 0 (baseline)

3 (2.9)

104

0 (0.0)

98

4 (4.0)

100

0 (0.0)

98

 
 

Days 0 to ≤7d

7 (6.7)

104

5 (5.1)

98

9 (9.0)

100

4 (4.1)

98

 
 

>Days 7 to ≤14

2 (2.1)

97

2 (2.2)

89

4 (4.4)

90

1 (1.3)

79

 
 

>Days 14 ≤ 90

5 (6.0)

84

4 (4.9)

81

1 (1.3)

79

1 (1.4)

74

 

Bacteremia

Overall

10 (9.6)

104

7 (7.1)

98

9 (8.9)

101

6 (6.1)

98

0.7943

 

Day 0 (baseline)

1 (1.0)

104

0 (0.0)

98

1 (1.0)

101

0 (0.0)

98

 
 

Days 0 to ≤7d

4 (3.8)

104

5 (5.1)

98

5 (5.0)

101

4 (4.1)

98

 
 

>Days 7 to ≤14

1 (1.0)

97

1 (1.1)

89

3 (3.3)

91

1 (1.3)

79

 
 

>Days 14 ≤ 90

5 (6.0)

84

1 (1.2)

81

1 (1.3)

80

1 (1.4)

74

 

Pneumonia

Overall

5 (4.8)

104

4 (4.1)

98

6 (6.0)

100

0 (0.0)

98

0.0693

 

Day 0 (baseline)

2 (2.0)

104

0 (0.0)

98

4 (4.0)

100

0 (0.0)

98

 
 

Days 0 to ≤7d

4 (3.8)

104

0 (0.0)

98

5 (5.0)

100

0 (0.0)

98

 
 

>Days 7 to ≤14

1 (1.0)

97

1 (1.1)

89

1 (1.1)

90

0 (0.0)

79

 
 

>Days 14 ≤ 90

0 (0.0)

84

3 (3.7)

81

0 (0.0)

79

0 (0.0)

74

 

Tracheo-bronchitis

Overall

5 (4.8)

104

12 (12.2)

98

9 (9.0)

100

8 (8.2)

98

0.3022

Day 0 (baseline)

0 (0.0)

104

1 (1.0)

98

1 (1.0)

100

0 (0.0)

98

 

Days 0 to ≤7d

3 (2.9)

104

4 (4.1)

98

4 (4.0)

100

5 (5.1)

98

 

>Days 7 to ≤14

1 (1.0)

97

6 (6.7)

89

0 (0.0)

90

0 (0.0)

79

 

>Days 14 ≤ 90

1 (1.2)

84

2 (2.5)

81

5 (6.3)

79

2 (2.7)

74

 

Central venous catheter infection

Overall

1 (1.2)

84

0 (0.0)

74

3 (4.1)

73

2 (2.6)

76

0.2863

Day 0 (baseline)

0 (0.0)

84

0 (0.0)

74

0 (0.0)

73

0 (0.0)

76

 

Days 0 to ≤7d

0 (0.0)

84

0 (0.0)

74

1 (1.4)

73

0 (0.0)

76

 

>Days 7 to ≤14

0 (0.0)

77

0 (0.0)

67

0 (0.0)

66

0 (0.0)

60

 

>Days 14 ≤ 90

1 (1.6)

64

0 (0.0)

61

2 (3.5)

57

2 (3.6)

55

 

Wound infection

Overall

9 (11.0)

82

6 (8.5)

71

8 (10.7)

75

6 (7.8)

77

0.8960

Day 0 (baseline)

1 (1.2)

82

0 (0.0)

71

2 (2.7)

75

1 (1.3)

77

 

Days 0 to ≤7d

4 (4.9)

82

2 (2.8)

71

3 (4.0)

75

2 (2.6)

77

 

>Days 7 to ≤14

0 (0.0)

75

2 (3.1)

64

1 (1.5)

67

2 (3.3)

61

 

>Days 14 ≤ 90

5 (8.1)

62

2 (3.4)

58

4 (6.9)

58

2 (3.5)

57

 

Urinary tract infection

Overall

4 (3.8)

104

5 (5.1)

98

7 (6.9)

101

9 (9.3)

97

0.4380

Day 0 (baseline)

0 (0.0)

104

0 (0.0)

98

1 (1.0)

101

0 (0.0)

97

 

Days 0 to ≤7d

0 (0.0)

104

1 (1.0)

98

2 (2.0)

101

1 (1.0)

97

 

>Days 7 to ≤14

2 (2.1)

97

0 (0.0)

89

2 (2.2)

91

3 (3.8)

78

 

>Days 14 ≤ 90

2 (2.4)

84

4 (4.9)

81

3 (3.8)

80

5 (6.8)

73

 
  1. Note, percentages are based on the numbers of non-missing observations (n). ITT intention-to-treat, n (%) number (%) of patients, N number of patients in treatment group, N’ number of patients with assessable data at start of the observation period, w/o adj without aluminum hydroxide adjuvant, with adj with aluminum hydroxide adjuvant. aConfirmed by Clinical Endpoint Committee. bFisher-Freeman-Halton test, cbacteremia or pneumonia. dData from day 0 (baseline) are included in the row for days 0 to ≤7. Therefore, the data for Overall include the rows for days 0 to ≤7, >days 7 to ≤14, and > days 14 to ≤90 rows, but not row for day 0 (baseline)
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