Document Detail

A multicenter, randomized trial of prophylactic fluconazole in preterm neonates.
MedLine Citation:
PMID:  17568029     Owner:  NLM     Status:  MEDLINE    
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 []).
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; ;
Related Documents :
21270469 - Predictors of outcome in term infants with neonatal seizures subsequent to intrapartum ...
1766709 - Pseudooutbreak of candida guilliermondii fungemia in a neonatal intensive care unit.
6342099 - Selection of antimicrobial agents for treatment of neonatal sepsis.
21918269 - Short-term corticosteroids for celiac crisis in infants.
10771949 - Endotracheal aspirate cultures in predicting sepsis in ventilated neonates.
15981749 - Mastitis in early infancy.
18422809 - Iron supplementation of iron-replete indonesian infants is associated with reduced weig...
22274959 - Maternal responses to dead infants in yunnan snub-nosed monkey (rhinopithecus bieti) in...
22490179 - Active music classes in infancy enhance musical, communicative and social development.
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.
Neonatology and Hospital Neonatal Intensive Care Unit, Sant'Anna Hospital, Turin, Italy.
Data Bank Information
Bank Name/Acc. No.:
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Antifungal Agents / therapeutic use*
Candida / isolation & purification
Candidiasis / epidemiology,  mortality,  prevention & control*
Cholestasis / epidemiology
Double-Blind Method
Fluconazole / therapeutic use*
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases / mortality,  prevention & control*
Infant, Very Low Birth Weight*
Microbial Sensitivity Tests
Reg. No./Substance:
0/Antifungal Agents; 86386-73-4/Fluconazole
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

Previous Document:  Anidulafungin versus fluconazole for invasive candidiasis.
Next Document:  Relationship between number of medical conditions and quality of care.