Prophylactic fluconazole is effective in preventing fungal colonisation and infection in preterm neonates: a multicentre, randomised trial in Italy
| ISRCTN | ISRCTN85753869 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85753869 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/09/2006
- Registration date
- 25/09/2006
- Last edited
- 19/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Paolo Manzoni
Scientific
Scientific
Neonatology and Hospital NICU
C. Spezia 60
Torino
10126
Italy
| Phone | +39 (0) 113 134 304 |
|---|---|
| manzonipaolo@hotmail.it |
Study information
| Study design | Multicentre, prospective, randomised, double-blind, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| 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). |
| Ethics approval(s) | 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 |
| Condition | Neonatal fungal infection |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluconazole prophylaxis |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/05/2004 |
| Overall study end date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 267 |
| Participant 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. |
| Participant 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) |
| Recruitment start date | 01/05/2004 |
| Recruitment end date | 31/07/2005 |
Locations
Countries of recruitment
- Italy
Study participating centre
Neonatology and Hospital NICU
Torino
10126
Italy
10126
Italy
Sponsor information
Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna [ONLUS]) (Italy)
Charity
Charity
Corso Spezia 60
Torino
10126
Italy
| Phone | +39 (0)113 134 300 |
|---|---|
| ggomirato@hotmail.com | |
"ROR" |
https://ror.org/00k065b17 |
Funders
Funder type
Industry
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.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 01/01/2006 | Yes | No | ||
| Results article | 14/06/2007 | Yes | No |
