Trials / Terminated
TerminatedNCT00815516
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 48 Hours – 120 Days
- Healthy volunteers
- Not accepted
Summary
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
Detailed description
Neonates and young infants will be stratified by estimated gestational age and by world region
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | micafungin | Administered by intravenous infusion |
| DRUG | amphotericin B deoxycholate | Administered by intravenous infusion |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2008-12-30
- Last updated
- 2015-11-04
- Results posted
- 2015-09-15
Locations
17 sites across 12 countries: United States, Brazil, Bulgaria, Canada, Colombia, Greece, Hungary, Israel, Philippines, Romania, Turkey (Türkiye), Ukraine
Source: ClinicalTrials.gov record NCT00815516. Inclusion in this directory is not an endorsement.