Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis (MAGIC-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT00815516
First received: December 27, 2008
Last updated: September 24, 2014
Last verified: September 2014

December 27, 2008
September 24, 2014
June 2012
December 2016   (final data collection date for primary outcome measure)
Fungal free survival [ Time Frame: One week following the last dose of study drug (maximum of 49 days) ] [ Designated as safety issue: No ]
Defined as alive at one week following the last dose of study drug and eradication (fungal free) with no requirement for alternative systemic antifungal therapy for continued treatment
Fungal free survival [ Time Frame: Last dose + 1 week ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00815516 on ClinicalTrials.gov Archive Site
  • Time to mycological clearance of invasive candidiasis [ Time Frame: 30 days following the last dose of study drug (maximum of 72 days) ] [ Designated as safety issue: No ]
  • Fungal free survival in infants with end-organ dissemination at end of study drug therapy [ Time Frame: maximum of 42 days ] [ Designated as safety issue: No ]
  • Fungal free survival in infants with end-organ dissemination one week after last dose of study drug [ Time Frame: maximum of 49 days ] [ Designated as safety issue: No ]
  • Overall incidence of emergent fungal infections through the end of study [ Time Frame: 30 days following the last dose of study drug (maximum of 72 days) ] [ Designated as safety issue: No ]
  • Overall incidence of recurrent fungal infections through the end of study [ Time Frame: 30 days following the last dose of study drug (maximum of 72 days) ] [ Designated as safety issue: No ]
  • Time to positive clinical response (complete or partial) [ Time Frame: 30 days following the last dose of study drug (maximum of 72 days) ] [ Designated as safety issue: No ]
  • Clinical response (complete, partial, stabilization, progression) at the end of study drug therapy [ Time Frame: maximum of 42 days ] [ Designated as safety issue: No ]
  • Clinical response (complete, partial, stabilization, progression) one week after last dose of study drug [ Time Frame: maximum of 49 days ] [ Designated as safety issue: No ]
  • Mycological response at end of study drug therapy [ Time Frame: maximum of 42 days ] [ Designated as safety issue: No ]
    Based on eradication and persistence
  • Mycological response one week after last dose of study drug [ Time Frame: maximum of 49 days ] [ Designated as safety issue: No ]
  • Status of follow-up imaging and exams (improved, stable, worse) for infants with end-organ assessments [ Time Frame: 30 days following the last dose of study drug (maximum of 72 days) ] [ Designated as safety issue: No ]
    End-organ dissemination will be assessed through abdominal ultrasound and/or computed tomography (CT), echocardiogram, head imaging and retinal exam
  • Pharmacokinetics model parameters [ Time Frame: Day 4 up to a maximum of 42 days (3 time points) ] [ Designated as safety issue: No ]
    Clearance and volume of distribution
Not Provided
Not Provided
Not Provided
 
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

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.

Neonates and young infants will be stratified by estimated gestational age and by world region

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Candidiasis
  • Drug: micafungin
    IV administration
    Other Names:
    • Mycamine
    • FK463
  • Drug: amphotericin B deoxycholate
    IV administration
    Other Names:
    • Fungizone
    • CAB
    • Amphotericin B for injection
  • Experimental: 1. micafungin
    Intervention: Drug: micafungin
  • Active Comparator: 2. amphotericin B deoxycholate
    Intervention: Drug: amphotericin B deoxycholate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
225
December 2016
December 2016   (final data collection date for primary outcome measure)

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 or candidemia 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
Both
up to 120 Days
No
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com
United States,   Argentina,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Greece,   Hungary,   Israel,   Mexico,   Peru,   Philippines,   Romania,   South Africa,   Taiwan,   Turkey,   Ukraine
 
NCT00815516
9463-CL-2303, 2012-000780-24
Yes
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Astellas Pharma Global Development, Inc.
Not Provided
Study Director: Senior Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP