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 July 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: July 14, 2014
Last verified: July 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

  Hide Study Locations
Locations
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
United States, Connecticut
Connecticut Children's NICU at University of Connecticut Health Center Withdrawn
Farmington, Connecticut, United States, 06030
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Dept of Pediatrics, University of Florida College of Medicine Withdrawn
Gainesville, Florida, United States, 32611
Nemours Children's Clinic Recruiting
Orlando, Florida, United States, 32827
United States, Kansas
Wesley Medical Center Recruiting
Wichita, Kansas, United States, 67214
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
St John's Mercy Medical Center Recruiting
St. Louis, Missouri, United States, 63141
United States, New Jersey
Morristown Memorial Hospital Withdrawn
Morristown, New Jersey, United States, 07960
UMDNJ/Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Westchester Medical Center Recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
WakeMed Health and Hospitals Recruiting
Raleigh, North Carolina, United States, 27610
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
The University of Texas Medical Branch Withdrawn
Galveston, Texas, United States, 77555-0435
University of Texas Medical School Recruiting
Houston, Texas, United States, 77030
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
United States, Utah
University Of Utah Recruiting
Salt Lake City, Utah, United States, 84108
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Argentina
Hospital De Ninos De Santa Fe Dr. Orlando Alassia Withdrawn
Santa Fe, Argentina, S3000CII
Brazil
Hospital das Clínicas da Universidade Federal de Goiás Recruiting
Goiânia, Goias, Brazil, 74605-020
Irmandade da Santa Casa de Misericórdia de Belo Horizonte Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Hospital de Clinicas do Parana Recruiting
Curitiba, Parana, Brazil, 80060-900
Hospital de Base da Faculdade de Medicina Suspended
São José do Rio Preto, Sao Paulo, Brazil, 15090-000
Pro Matre Paulista Recruiting
Sao Paulo, Brazil, 01403-001
Hospital e Maternidade Santa Joana Recruiting
São Paulo, Brazil, 04103-000
Bulgaria
Multiprofile Hospital for Active Treatment Recruiting
Gabrovo, Bulgaria, 5300
Spec Hospital for Active Treatment of Children Diseases Recruiting
Sofia, Bulgaria, 1606
First Municipal Hospital for Active Treatment-Sofia Recruiting
Sofia, Bulgaria, 1142
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Chile
Hospital Padre Hurtado Recruiting
Santiago, Chile, 8880465
Hospital Clinico de la Pontificia Universidad Catolica de Chile Recruiting
Santiago, Chile, 22354 3000
Colombia
Hospital Pablo Tobon Uribe Recruiting
Medellin, Antioque, Colombia, 574
Centro Medico Imbanaco Recruiting
Cali, Colombia
Croatia
Klinichiki Bolnicki Centar-Zagreb Recruiting
Zagreb, Croatia, 10000
Greece
'P&A Kyriakou' Childrens' General Hospital of Athens Recruiting
Athens, Greece, 11527
Elena Venizelou hospital Recruiting
Athens, Greece, 11521
University Hospital of Patras Recruiting
Patras, Greece, 26504
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, 8200
Pándy Kálmán Megyei Kórház Recruiting
Gyula, Hungary, 5700
BAZ County Hospital Recruiting
Miskolc, Hungary, 3526
Jósa András Oktató Kórház Nonprofit Kft. Recruiting
Nyíregyháza, Hungary, 4400
Israel
Bnei Zion Medical Center Recruiting
Haifa, Israel, 31048
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Edith Wolfson Medical Center Recruiting
Holon, Israel, 58100
Hadassah University Hospital Ein Kerem Recruiting
Jerusalem, Israel, 91120
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
The Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52661
Mexico
Hospital Universitario "Dr. José Eleuterio Gonzalez" (Universidad Autonoma de Nuevo Leon) Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Hospital Central Dr. Ignacio Morones Prieto Recruiting
San Luis Potosi, Mexico, 78250
Peru
Hospital Nacional Cayetano Heredia Recruiting
Lima, Peru, 31
Hospital Nacional Arzobispo Loayza Recruiting
Lima, Peru, 1
Instituto Neuro Cardiovascular de las Américas Recruiting
Miraflores, Lima, Peru, 18
Philippines
Philippine General Hospital Recruiting
Manila, Philippines
Romania
Prof. Dr. Alfred Rusescu Institute of Mother and Child Care Recruiting
Bucharest, Romania, 11062
Emergency County Clinical Hospital Recruiting
Cluj-Napoca, Romania, 400006
South Africa
University of Limpopo Recruiting
Limpopo, South Africa, 0204
Taiwan
Taichung Veteran General Hospital Recruiting
Taichung, Taiwan
Turkey
Cukurova University Medical Faculty Recruiting
Adana, Turkey, 1330
Istanbul University Faculty of Medicine Recruiting
Istanbul, Turkey, 34093
Kocaeli University Hospital Recruiting
Kocaeli, Turkey, 41380
Ukraine
Community Institution "Regional Children Clinical Hospital" Recruiting
Dnipropetrovsk, Ukraine, 49100
Municipal Institution "Donetsk Regional Center of Mother and Child Care" Suspended
Donetsk, Ukraine, 83114
Lugansk Regional Childrens Clinical Hospital Suspended
Lugansk, Ukraine, 91016
Municipal Institution "Lviv City Clinical Childrens Hospital" Recruiting
Lviv, Ukraine, 79059
Municipal Institution "Odesa Regional Children's Hospital" Recruiting
Odesa, Ukraine, 65031
Vinnytsya Regional Children Clinical Hospital Recruiting
Vinnytsya, Ukraine, 21018
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: July 14, 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
Amphotericin B, deoxycholate drug combination
Micafungin
Deoxycholic Acid
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 24, 2014