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Table 1 Combined summary of demography and baseline characteristics of the MITT population and early switch subpopulation

From: Evaluation of an early step-down strategy from intravenous anidulafungin to oral azole therapy for the treatment of candidemia and other forms of invasive candidiasis: results from an open-label trial

 

MITT population

Early switch subpopulation

Patient demographics

 

Number of patients

250

102

Female (%)

115 (46.0)

49 (48.0)

Mean age (SD)

55.4 (16.9)

53.9 (17.7)

Median age (range)

56.0 (19–89)

53.0 (19–88)

Race (%)

  

  White

164 (65.6)

69 (67.6)

 Black

52 (20.8)

28 (27.5)

 Asian

26 (10.4)

1 (1.0)

 Other

8 (3.2)

4 (3.9)

Baseline characteristics

 

Number of patients (%)

250 (100.0)

102 (100.0)

Baseline site of infection (%)

  

 Blood only

210 (84.0)

86 (84.3)

 Other sterile site

38 (15.2)

16 (15.7)

 Blood and other sterile site

2 (0.8)

0

APACHE-II score

  

 n (%)

249 (99.6)

102 (100.0)

 Mean (SD)

14.3 (6.7)

12.7 (6.2)

 Median (range)

14.0 (2–36)

12.0 (2–29)

 > 20 (%)

47 (18.8)

14 (13.7)

ANC

  

 n (%)

227 (90.8)

93 (91.2)

 ≤ 500 cells/mm3 (%)

9 (3.6)

2 (2.0)

Length of ICU stay ≥ 4 days (%)*

82 (34.3)

23 (23.5)

Invasive candidiasis related to IV catheter*

 

 Yes (%)

104 (45.8)

44 (46.3)

   All catheters removed within 3 days of therapy?

    Yes

98 (94.2)

41 (93.2)

    No

6 (5.8)

3 (6.8)

 No (%)

41 (18.1)

14 (14.7)

   All catheters removed within 3 days of therapy?

    Yes

25 (61.0)

8 (57.1)

    No

16 (39.0)

6 (42.9)

Baseline isolates of Candida species, n (%)

C. albicans

112 (44.8)

46 (45.1)

C. glabrata

64 (25.6)

20 (19.6)

C. parapsilosis

41 (16.4)

20 (19.6)

C. tropicalis

27 (10.8)

11 (10.8)

C. krusei

11 (4.4)

4 (3.9)

 Other

9 (3.6)

6 (5.9)

Most commonly reported comorbidities (terms reported from ≥ 10%), n (%)

 Anemia

127 (50.8)

58 (56.9)

 Nausea

70 (28.0)

29 (28.4)

 Diabetes mellitus

48 (19.2)

27 (26.5)

 Hypokalemia

51 (20.4)

26 (25.5)

 Malnutrition

49 (19.6)

24 (23.5)

  1. *Risk factors for invasive candidiasis and catheter management data were systematically collected only after Case Report Form (CRF) revision shortly after study start. Percentages are based on the actual number of patients enrolled in the study after these CRFs were incorporated.
  2. Abbreviations used: ANC, absolute neutrophil count; APACHE, Acute Physiology and Chronic Health Evaluation; ICU, intensive care unit; IV, intravenous; MITT, modified intent-to-treat; SD, standard deviation.