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

This study has been suspended.

( Further evaluation of pharmacokinetic data in the target population is ongoing )

First Received on December 27, 2008. Last Updated on December 7, 2011 History of Changes

Sponsor:	Astellas Pharma Inc
Information provided by (Responsible Party):	Astellas Pharma 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 infants with certain fungal infections.

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

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: Molds Yeast Infections

Drug Information available for: FK 463 Micafungin Amphotericin B

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Fungal free survival [ Time Frame: Last dose + 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	225
Study Start Date:	February 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (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:

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 invasive candidiasis or candidemia within 4 days prior to study start

Exclusion Criteria:

Infant with any history of a hypersensitivity 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

Show 20 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Senior Medical Director

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00815516 History of Changes
Other Study ID Numbers:	04-0-199, 9463-CL-2303, 2008-005936-34
Study First Received:	December 27, 2008
Last Updated:	December 7, 2011
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 February 09, 2012