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
  Purpose

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.


Condition Intervention Phase
Candidiasis
Drug: micafungin
Drug: amphotericin B deoxycholate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 225
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. micafungin Drug: micafungin
IV administration
Other Names:
  • Mycamine
  • FK463
Active Comparator: 2. amphotericin B deoxycholate Drug: amphotericin B deoxycholate
IV administration
Other Names:
  • Fungizone
  • CAB
  • Amphotericin B for injection

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   up to 120 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815516

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com

  Show 70 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT00815516     History of Changes
Other Study ID Numbers: 9463-CL-2303, 2012-000780-24
Study First Received: December 27, 2008
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Chile: Instituto de Salud Pública de Chile
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Peru: Ministry of Health
Mexico: Ministry of Health
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Israel: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Bulgaria: Bulgarian Drug Agency
Croatia: Ministry of Health and Social Care
Ecuador: Public Health Ministry
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Korea: Food and Drug Administration
Philippines: Bureau of Food and Drugs
Romania: National Medicines Agency
South Africa: Medicines Control Council
Taiwan : Food and Drug Administration
Thailand: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
candidiasis
candida
Neonate
candidemia
Micafungin
Mycamine
amphotericin B deoxycholate

Additional relevant MeSH terms:
Candidiasis
Infant, Newborn, Diseases
Mycoses
Amphotericin B
Liposomal amphotericin B
Micafungin
Amphotericin B, deoxycholate drug combination
Deoxycholic Acid
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on October 16, 2014