Randomized control trial on the efficacy of a preemptive therapy based on positive Mn-antigen detection in BALF in an invasive candidiasis high risk population of preterm infants

Randomized control trial on the efficacy of a preemptive therapy based on positive Mn-antigen detection in BALF in an invasive candidiasis high risk population of preterm infants - Preemptive antimicotic therapy and Mn-antigen detection in preterm neonatal BALF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025633

Enrollment

114

Registered

2017-01-14

Start date

2014-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive candidiasis risk in preterm neonates

Interventions

Administration of Voriconazole iv at the dose of 9 mg/kg twice a day in the first day of treatment, andc then 8 mg/kg twice a day for others 13 days Administration of Micafungin iv at the dose of 10

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Neonates with gestational age <= 30 weeks and/or birth weight <= 1000 gr, needing mechanical ventilation in the first week of life and receiving fluconazole prophylaxis

Exclusion criteria

Exclusion criteria: Major malformation

Design outcomes

Primary

Measure	Time frame
Day of extubation Incidence of BPD at 36 weeks of postconceptual age	—

Countries

Europe

Contacts

Public ContactGiovanni Vento

Fondazione Policlinico Universitario Agostino Gemelli Neonatology

giovanni.vento@unicatt.it+390630154357

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026