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

This study is currently recruiting participants.

Verified by Astellas Pharma Inc, December 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	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

MedlinePlus related topics: Yeast Infections

Drug Information available for: Amphotericin B Micafungin FK 463

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

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:	December 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. micafungin: Experimental	Drug: micafungin IV administration
2. amphotericin B deoxycholate: Active Comparator	Drug: amphotericin B deoxycholate IV administration

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

Contacts

Contact: Astellas Pharma US Medical Information

800-888-7704 ext 5473

clintrials.info@us.astellas.com

Locations

United States, Alabama
	Recruiting
Birmingham, Alabama, United States, 95233
United States, Kansas
	Not yet recruiting
Wichita, Kansas, United States, 67214
United States, New York
	Not yet recruiting
Stony Brook, New York, United States, 11794
	Not yet recruiting
Valhalla, New York, United States, 10595
United States, Tennessee
	Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Utah
	Not yet recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
	Not yet recruiting
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	04-0-199, 9463-CL-2303, EudraCT 2008-005936-34
Study First Received:	December 27, 2008
Last Updated:	December 27, 2008
ClinicalTrials.gov Identifier:	NCT00815516
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

Study placed in the following topic categories:

Abelcet
Amphotericin B
Mycoses
Candidiasis
Clotrimazole
Miconazole

Tioconazole
Deoxycholic Acid
Amphotericin B-deoxycholate
Liposomal amphotericin B
Torulopsis
Micafungin

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Cholagogues and Choleretics
Antifungal Agents

Therapeutic Uses
Gastrointestinal Agents
Antibiotics, Antifungal
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009