Document Detail


A multicenter, randomized trial of prophylactic fluconazole in preterm neonates.
MedLine Citation:
PMID:  17568029     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Invasive candida infections are a major cause of morbidity and mortality in preterm infants. We performed a multicenter, randomized, double-blind, placebo-controlled trial of fluconazole for the prevention of fungal colonization and infection in very-low-birth-weight neonates. METHODS: During a 15-month period, all neonates weighing less than 1500 g at birth from eight tertiary Italian neonatal intensive care units (322 infants) were randomly assigned to receive either fluconazole (at a dose of either 6 mg or 3 mg per kilogram of body weight) or placebo from birth until day 30 of life (day 45 for neonates weighing <1000 g at birth). We performed weekly surveillance cultures and systematic fungal susceptibility testing. RESULTS: Among infants receiving fluconazole, fungal colonization occurred in 9.8% in the 6-mg group and 7.7% in the 3-mg group, as compared with 29.2% in the placebo group (P<0.001 for both fluconazole groups vs. the placebo group). The incidence of invasive fungal infection was 2.7% in the 6-mg group and 3.8% in the 3-mg group, as compared with 13.2% in the placebo group (P=0.005 for the 6-mg group and P=0.02 for the 3-mg group vs. the placebo group). The use of fluconazole did not modify the relationship between colonization and the subsequent development of invasive fungal infection. Overall mortality was similar among groups, as was the incidence of cholestasis. No evidence for the emergence of resistant candida species was observed, but the study did not have substantial power to detect such an effect. CONCLUSIONS: Prophylactic fluconazole reduces the incidence of colonization and invasive candida infection in neonates weighing less than 1500 g at birth. The benefit of treating candida colonization is unclear. (Current Controlled Trials number, ISRCTN85753869 [controlled-trials.com]).
Authors:
Paolo Manzoni; Ilaria Stolfi; Lorenza Pugni; Lidia Decembrino; Cristiana Magnani; Gennaro Vetrano; Elisabetta Tridapalli; Giuseppina Corona; Chiara Giovannozzi; Daniele Farina; Riccardo Arisio; Franco Merletti; Milena Maule; Fabio Mosca; Roberto Pedicino; Mauro Stronati; Michael Mostert; Giovanna Gomirato; ;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  356     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2007 Jun 
Date Detail:
Created Date:  2007-06-14     Completed Date:  2007-06-21     Revised Date:  2007-12-13    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2483-95     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2007 Massachusetts Medical Society.
Affiliation:
Neonatology and Hospital Neonatal Intensive Care Unit, Sant'Anna Hospital, Turin, Italy. paolomanzoni@hotmail.com
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN85753869
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MeSH Terms
Descriptor/Qualifier:
Antifungal Agents / therapeutic use*
Candida / isolation & purification
Candidiasis / epidemiology,  mortality,  prevention & control*
Cholestasis / epidemiology
Double-Blind Method
Female
Fluconazole / therapeutic use*
Humans
Incidence
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases / mortality,  prevention & control*
Infant, Very Low Birth Weight*
Male
Microbial Sensitivity Tests
Chemical
Reg. No./Substance:
0/Antifungal Agents; 86386-73-4/Fluconazole
Comments/Corrections
Comment In:
N Engl J Med. 2007 Jun 14;356(24):2525-6   [PMID:  17568034 ]
J Pediatr. 2007 Nov;151(5):553-4   [PMID:  17961708 ]
N Engl J Med. 2007 Sep 27;357(13):1348-9; author reply 1349   [PMID:  17898108 ]
N Engl J Med. 2007 Sep 27;357(13):1349; author reply 1349   [PMID:  17902203 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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