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Fluconazole prophylaxis in preterm infants: a multicenter case-controlled analysis of efficacy and safety.

Abstract：

BACKGROUND:Fluconazole prophylaxis has demonstrated efficacy in single and multicenter randomized controlled trials without side effects or emergence of resistance. Additional evidence based on incidence of invasive Candida infections, multicenter data, resistance, and safety is desired. METHODS:We conducted a case-control analysis of efficacy and safety of fluconazole prophylaxis from a multicenter database from a neonatal infection study that included 2017 infants <1250 grams from 95 NICUs. Infants receiving intravenous antifungal prophylaxis were pre-identified during enrollment in the parent study. For each infant receiving antifungal prophylaxis (case), three infants not receiving antifungal (controls) were matched by birth weight (± 50 g), by gestational age (± 1 week), gender, and study site. RESULTS:Fluconazole prophylaxis was administered to 127 patients [754 ± 163 g birth weight (BW) and 25.4 ± 1.7 weeks gestational age (GA)] and were compared with 399 control patients (756 ± 163 g BW and 25.5 ± 1.8 weeks GA). Invasive Candida infection occurred in 0.8% (1 of 127) infants who received fluconazole prophylaxis compared with 7.3% (29 of 399) of matched controls (p = 0.006). Candida bloodstream infection occurred in 0.8% (1 of 127) fluconazole prophylaxis infants compared with 5.5% (22 of 399) of matched controls (p = 0.02). There were no differences in late-onset sepsis due to gram-positive or gram-negative organisms, focal bowel perforation, necrotizing enterocolitis, cholestasis, or overall mortality. CONCLUSION:Fluconazole prophylaxis is safe and efficacious in preventing invasive Candida infections. Even in NICUs with a low incidence of invasive Candida infections, antifungal prophylaxis for high-risk infants is a proven and safe opportunity for infection prevention in these patients.

journal_name

Early Hum Dev

journal_title

Early human development

authors

Kaufman DA,Morris A,Gurka MJ,Kapik B,Hetherington S

doi

10.1016/S0378-3782(14)70026-X

subject

Has Abstract

pub_date

2014-03-01 00:00:00

pages

S87-90

eissn

0378-3782

issn

1872-6232

pii

S0378-3782(14)70026-X

journal_volume

90 Suppl 1

pub_type

临床试验,杂志文章,随机对照试验

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