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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 30
- Locations
- 17
- Primary Endpoint
- Fungal-free Survival
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 48 Hours to 120 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Micafungin
Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
Intervention: micafungin (Drug)
Amphotericin B deoxycholate
Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
Intervention: amphotericin B deoxycholate (Drug)
Outcomes
Primary Outcomes
Fungal-free Survival
Time Frame: One week after the last dose of study drug (maximum of 49 days)
Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at one week following the last dose of study drug with a mycological response of eradication and no requirement for alternative systemic antifungal therapy for continued treatment. Eradication was defined as culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for Candida meningitis and/or candiduria, 1 negative culture.
Secondary Outcomes
- Percentage of Participants With Emergent Fungal Infections(Up to 30 days after the last dose of study drug (maximum of 72 days))
- Time to Mycological Clearance of Invasive Candidiasis(From first dose up to 30 days after the last dose of study drug (maximum of 72 days))
- Clinical Response at the End of Study Drug Therapy(Baseline and end of study drug therapy; maximum of 42 days)
- Mycological Response at End of Study Drug Therapy(End of study drug therapy; maximum of 42 days)
- Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination(The end of study drug therapy; maximum of 42 days)
- Percentage of Participants With Recurrent Fungal Infections(Up to 30 days after the last dose of study drug (maximum of 72 days))
- Time to Positive Clinical Response(From first dose up to 30 days after the last dose of study drug (maximum of 72 days))
- Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination(One week after the last dose of study drug (maximum of 49 days))
- Clinical Response One Week After Last Dose of Study Drug(Baseline and one week after the last dose of study drug (maximum of 49 days))
- Mycological Response One Week After Last Dose of Study Drug(One week after the last dose of study drug (maximum of 49 days))
- Follow-up Status for Infants With End-organ Assessments(Baseline and 30 days after the last dose of study drug (maximum of 72 days))
- Plasma Micafungin Concentration(15 minutes post intravenous infusion (IV), 4-8 hours post IV and 15-24 hours post IV)