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 |
Data from reference 246.
Growth of fungus in culture for a patient with symptoms of infection.