TABLE 6.

Summary of fluconazole prophylaxis study in ELBW infantsa

CharacteristicResults for:P
Fluconazole patients (n = 50)Placebo patients (n = 50)
No. (%) of patients with fungal infectionb
    Blood, urine, or cerebrospinal fluid infection0 (0)10 (20)0.008
    Bloodstream infection0 (0)8 (16)0.007
No. (%) of patients with fungal colonization
    One or more sites11 (22)30 (60)0.002
    Two or more sites9 (18)26 (52)0.003
    Skin10 (20)24 (48)0.008
    Gastrointestinal tract9 (18)27 (54)0.003
    Respiratory tract1 (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 ± 1329 ± 160.67
    Alanine aminotransferase (IU/liter)21 ± 1621 ± 190.85
    Direct bilirubin (mg/dl)0.6 ± 1.41.0 ± 1.80.34
    Alkaline phosphatase (IU/liter)305 ± 125318 ± 1820.70
No. (%) patients who died4 (8)10 (20)0.22
  • a Data from reference 246.

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