Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis - Full Text View

Sponsor:	Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):	Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:	NCT00815516

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:

MedlinePlus related topics: Fungal Infections Molds Yeast Infections

Drug Information available for: Amphotericin B Micafungin sodium Liposomal Amphotericin B

U.S. FDA Resources

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:	May 2012
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (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

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 or sputum

Contacts and Locations

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

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:	April 18, 2012
Health Authority:	United States: Food and Drug Administration European Union: European Medicines Agency Chile: Instituto de Salud Publica 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

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 May 23, 2012