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. 2004 Jul;17(3):638–680. doi: 10.1128/CMR.17.3.638-680.2004

TABLE 6.

Summary of fluconazole prophylaxis study in ELBW infantsa

Characteristic Results for:
P
Fluconazole patients (n = 50) Placebo patients (n = 50)
No. (%) of patients with fungal infectionb
    Blood, urine, or cerebrospinal fluid infection 0 (0) 10 (20) 0.008
    Bloodstream infection 0 (0) 8 (16) 0.007
No. (%) of patients with fungal colonization
    One or more sites 11 (22) 30 (60) 0.002
    Two or more sites 9 (18) 26 (52) 0.003
    Skin 10 (20) 24 (48) 0.008
    Gastrointestinal tract 9 (18) 27 (54) 0.003
    Respiratory tract 1 (2) 21 (42) 0.002
Resistance (MIC50) (μg/ml)
    First 6 mo of study ≤2.0 ≤1.0
    Last 6 mo of study ≤2.0 ≤1.0
Patient safety (liver function tests, mean ± SD)
    Aspartate aminotransferase (IU/liter) 27 ± 13 29 ± 16 0.67
    Alanine aminotransferase (IU/liter) 21 ± 16 21 ± 19 0.85
    Direct bilirubin (mg/dl) 0.6 ± 1.4 1.0 ± 1.8 0.34
    Alkaline phosphatase (IU/liter) 305 ± 125 318 ± 182 0.70
No. (%) patients who died 4 (8) 10 (20) 0.22
a

Data from reference 246.

b

Growth of fungus in culture for a patient with symptoms of infection.