Table 2.
Randomized Controlled Trials of Fluconazole Prophylaxis
| Study | N | Study Population Weight |
Trial Design | Primary End Point |
IC and Mortality: Fluconazole Group |
IC and Mortality: Placebo Group |
Comments |
|---|---|---|---|---|---|---|---|
| Kaufman et al12 | 100 | <1000 g | Single-center RCT | IC Mortality |
0/50 4/50 (8.0%) |
10/50 (20.0%) 10/50 (20.0%) |
Reduced IC but not mortality |
| Kicklighter et al104 | 103 | <1500 g | Single-center RCT | Colonization Mortality |
8/53 (15.1%) 5/53 (9.4%) |
23/50 (46.0%) 10/50 (20%) |
Did not reduce invasive candidiasis or mortality |
| Manzoni et al102 | 322 | <1500 g | Multicenter, 3 arm RCT | IC Mortality |
7/216 (3.2%) 18/216 (8.3%) Post hoc 3 + 6 mg composite |
14/106(13.2%) 10/106(9.4%) |
Reduced IC but not mortality |
| Parikh et al104 | 120 | <1500 g | Single-center RCT | IC Mortality |
16/60 (26.7%) 17/60 (28.3%) |
15/60 (25.0%) 17/60 (28.3%) |
No difference in IC or mortality |
IC, invasive candidiasis; RCT, randomized controlled trial; PNA, postnatal age; DOL, day of life.