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Prophylactic fluconazole is effective in preventing fungal colonisation and infection in preterm neonates: a multicentre, randomised trial in Italy
ISRCTN ISRCTN85753869
DOI 10.1186/ISRCTN85753869
ClinicalTrials.gov identifier
EudraCT number
Public title Prophylactic fluconazole is effective in preventing fungal colonisation and infection in preterm neonates: a multicentre, randomised trial in Italy
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis To evaluate the efficacy of fluconazole prophylaxis in prevention of fungal colonisation and infection (colonisation by Candida spp., or invasive infection caused by Candida spp.) in preterm very low birth weight (i.e., less than 1500 g at birth) infants in Neonatal Intensive Care Units (NICUs).
Lay summary
Ethics approval Ethics Board of the Fondazione Crescere Insieme al Sant'Anna-ONLUS approved of the study on the 15/04/2004. The Fondazione is a Charity and Scientific Foundation of the Sant' Anna Hospital Institution.

Each participating Institution reviewed the protocol and was notified of the Fondazione's approval:
1. Policlinico Umberto I^ of Rome
2. Carlo Poma Hospital of Mantua
3. Mangiagalli Hospital of Milan
4. S. Matteo Hospital of Pavia
5. Arcispedale of Reggio Emilia
6. Fatebenefratelli Hospital of Benevento
7. Department of Pediatrics, University of Messina
8. Department of Pediatrics, University of Bologna
Study design Multicentre, prospective, randomised, double-blind, placebo-controlled trial
Countries of recruitment Italy
Disease/condition/study domain Neonatal fungal infection
Participants - inclusion criteria All neonates with birth weight less than 1500 g (i.e. Very Low Birth Weight [VLBW]) born within the study period, whether at one of the eight Institutions or elsewhere, were eligible for the study.
Participants - exclusion criteria 1. Parental refusal
2. Admission after 72 hours of life
3. Death prior to 72 hours of life
4. Liver failure (defined as three-fold elevation of Aspartate Aminotransferase [AST] and/or Alanine Aminotransferase [ALT] above the reference values)
Anticipated start date 01/05/2004
Anticipated end date 31/07/2005
Status of trial Completed
Patient information material
Target number of participants 267
Interventions The regimens in the two intervention groups was 6 and 3 mg/kg of fluconazole (DIFLUCAN®; Pfizer Italia S.p.A.; Latina/Roma; Italy) every third day for the first two weeks, then every other day.

Six weeks (in infants with birth weight less than 1000 g, i.e. Extremely Low Birth Weight [ELBW]) and four weeks (in the infants with birth weight 1001 to 1500 g) were chosen as the duration of therapy on the basis of the currently published data, unless earlier discharge or need for systemic antifungal therapy due to the onset of proven or presumed invasive fungal infection.

Prophylaxis started from day of life three via a single dose intravenously or orally (via orogastric tube), depending on the availability of a venous line and/or the tolerance of oral feeding. Infants in the control group received placebo (1 ml saline) in the same way.
Primary outcome measure(s) The primary objective of the study was to evaluate the effectiveness of 3 and 6 mg/kg fluconazole compared with placebo in the prevention of Candida colonisation and infection in the preterm very low birth weight neonates admitted to the participant NICUs.
Secondary outcome measure(s) 1. Assessment of the incidence of Gram-positive and Gram-negative sepsis
2. Mortality (overall and Candida-attributable)
3. Rate of progression from colonisation to infection
4. Necrotising enterocolitis
5. Ligation of patent ductus arteriosus
6. Threshold retinopathy of prematurity requiring surgery
7. Severe (grade 3-4) intraventricular haemorrhage
8. Bronchopulmonary dysplasia
9. Alteration of liver function as measured by serum AST, ALT, direct bilirubin and gamma-Glutamyl Transferase (gGT) values at baseline and at the end of all administrations
Sources of funding Pfizer Italia S.p.A. (Italy) - supplied study drugs, provided financial support with a grant, but was not involved in the concept, design, enrolment, data collection, analysis and interpretation of its results.
Trial website
Publications Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17568029
2. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=16326690
Contact name Dr  Paolo  Manzoni
  Address Neonatology and Hospital NICU
C. Spezia 60
  City/town Torino
  Zip/Postcode 10126
  Country Italy
  Tel +39 (0) 113 134 304
  Fax +39 (0) 113 134 888
  Email manzonipaolo@hotmail.it
Sponsor Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna [ONLUS]) (Italy)
  Address Corso Spezia 60
  City/town Torino
  Zip/Postcode 10126
  Country Italy
  Tel +39 (0)113 134 300
  Email ggomirato@hotmail.com
Date applied 19/09/2006
Last edited 19/09/2007
Date ISRCTN assigned 25/09/2006
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