Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
Stopped early · Phase 3
Conditions studied: Candidiasis
In brief
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.
Key facts
- Study ID
- NCT00815516
- Run by
- Astellas Pharma Global Development, Inc.
- People needed
- 30
- Starts
- 2013-02-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-11-04
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infant greater than 48 hours of life after birth up to day of life 120 at the time of culture acquisition
- Diagnosis of proven invasive candidiasis within 4 days prior to study start
- Subject's parent or legal guardian agrees not to allow subject to participate in another study with another investigational drug while on treatment.
You may not qualify if…
- Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or systemic amphotericin B product
- Infant who has received more than 48 hours of systemic antifungal therapy prior to the first dose of study drug
- Infant who has a breakthrough systemic fungal infection while receiving amphotericin B product or an echinocandin as prophylaxis
- Infant who has failed prior systemic antifungal therapy for this episode of invasive candidiasis
- Infant who is co-infected with a non-Candida fungal organism
- Infant whose positive yeast cultures are solely from an indwelling bladder catheter (unless obtained at the time the indwelling catheter was placed) or sputum.
- Infant previously enrolled in this study
Where it is running
- Children's Hospital of Orange County — Orange, California, United States
- UMDNJ/Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
- Duke University — Durham, North Carolina, United States
- WakeMed Health and Hospitals — Raleigh, North Carolina, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- Irmandade da Santa Casa de Misericórdia de Belo Horizonte — Belo Horizonte, Minas Gerais, Brazil
- Hospital de Base da Faculdade de Medicina — São José do Rio Preto, São Paulo, Brazil
- Spec Hospital for Active Treatment of Children Diseases — Sofia, Bulgaria
- McMaster Children's Hospital — Hamilton, Ontario, Canada
- Hospital Pablo Tobon Uribe — Medellín, Antioque, Colombia
- University Hospital of Patras — Pátrai, Greece
- Semmelweis Egyetem — Budapest, Hungary
- Hadassah University Hospital Ein Kerem — Jerusalem, Israel
- Philippine General Hospital — Manila, Philippines
- Emergency County Clinical Hospital — Cluj-Napoca, Romania
- Cukurova University Medical Faculty — Adana, Turkey (Türkiye)
- Municipal Institution "Odesa Regional Children's Hospital" — Odesa, Ukraine
Full record on ClinicalTrials.gov
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