Study Details

Study to compare the efficacy and safety of micafungin versus conventional amphotericin B for the treatment of neonatal candidiasis

The study has stopped early and will not start again. Participants were not enrolled (for withdrawn studies), however if participants were enrolled, they are no longer being examined or treated. ID

The unique identification code given to each clinical study upon registration at

Astellas Study ID

The unique identification code given by the study sponsor.


EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).





These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3


48 Hours - 120 Days


Female & Male




A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


Trial Dates

Feb 2013 - Dec 2014


Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number


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

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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UCLA Medical Center

Los Angeles, United States, 90095

Children’s Hospital of Orange County

Orange, United States, 92868

Connecticut Children's NICU at University of Connecticut Health Center

Farmington, United States, 06030

Georgetown University Hospital

Washington, United States, 20007

Dept of Pediatrics, University of Florida College of Medicine

Gainesville, United States, 32611

Nemours Children's Clinic

Orlando, United States, 32827

Wesley Medical Center

Wichita, United States, 67214

Children's Hospital of Michigan

Detroit, United States, 48201

St John's Mercy Medical Center

St. Louis, United States, 63141

Morristown Memorial Hospital

Morristown, United States, 07960

UMDNJ/Robert Wood Johnson Medical School

New Brunswick, United States, 08901

Westchester Medical Center

Valhalla, United States, 10595

Duke University

Durham, United States, 27710

WakeMed Health and Hospitals

Raleigh, United States, 27610

Children's Hospital of Pittsburgh

Pittsburgh, United States, 15224

The University of Texas Medical Branch

Galveston, United States, 77555-0435

University of Texas Medical School

Houston, United States, 77030

Baylor College of Medicine

Houston, United States, 77030

University Of Utah

Salt Lake City, United States, 84108

University of Virginia

Charlottesville, United States, 22904

Virginia Commonwealth University

Richmond, United States, 23298

Hospital De Ninos De Santa Fe Dr. Orlando Alassia

Santa Fe, Argentina, S3000CII

Hospital das Clínicas da Universidade Federal de Goiás

Goiânia, Brazil, 74605-020

Irmandade da Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Brazil, 30150-221

Hospital de Clinicas do Parana

Curitiba, Brazil, 80060-900

Pro Matre Paulista

Sao Paulo, Brazil, 01403-001

Hospital de Base da Faculdade de Medicina

São José do Rio Preto, Brazil, 15090-000

Hospital e Maternidade Santa Joana

São Paulo, Brazil, 04103-000

Multiprofile Hospital for Active Treatment

Gabrovo, Bulgaria, 5300

Spec Hospital for Active Treatment of Children Diseases

Sofia, Bulgaria, 1606

First Municipal Hospital for Active Treatment-Sofia

Sofia, Bulgaria, 1142

McMaster Children's Hospital

Hamilton, Canada, L8N 3Z5

Hospital for Sick Children

Toronto, Canada, M5G 1X8

Hospital Padre Hurtado

Santiago, Chile, 8880465

Hospital Clinico de la Pontificia Universidad Catolica de Chile

Santiago, Chile, 22354 3000

Centro Medico Imbanaco

Cali, Colombia

Hospital Pablo Tobon Uribe

Medellin, Colombia, 574

Klinichiki Bolnicki Centar-Zagreb

Zagreb, Croatia, 10000

'P&A Kyriakou' Childrens' General Hospital of Athens

Athens, Greece, 11527

Elena Venizelou hospital

Athens, Greece, 11521

University Hospital of Patras

Patras, Greece, 26504

Semmelweis Egyetem

Budapest, Hungary, 8200

Pándy Kálmán Megyei Kórház

Gyula, Hungary, 5700

BAZ County Hospital

Miskolc, Hungary, 3526

Jósa András Oktató Kórház Nonprofit Kft.

Nyíregyháza, Hungary, 4400

Bnei Zion Medical Center

Haifa, Israel, 31048

Rambam Medical Center

Haifa, Israel, 31096

Edith Wolfson Medical Center

Holon, Israel, 58100

Hadassah University Hospital Ein Kerem

Jerusalem, Israel, 91120

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

The Chaim Sheba Medical Center

Tel Hashomer, Israel, 52661

Hospital Universitario "Dr. José Eleuterio Gonzalez" (Universidad Autonoma de Nuevo Leon)

Monterrey, Mexico, 64460

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosi, Mexico, 78250

Hospital Nacional Cayetano Heredia

Lima, Peru, 31

Hospital Nacional Arzobispo Loayza

Lima, Peru, 1

Instituto Neuro Cardiovascular de las Américas

Miraflores, Lima, Peru, 18

Philippine General Hospital

Manila, Philippines

Prof. Dr. Alfred Rusescu Institute of Mother and Child Care

Bucharest, Romania, 11062

Emergency County Clinical Hospital

Cluj-Napoca, Romania, 400006

Emergency County Clinical Hospital

Cluj-Napoca, Romania, 400006

University of Limpopo

Limpopo, South Africa, 0204

Taichung Veteran General Hospital

Taichung, Taiwan, Province of China

Cukurova University Medical Faculty

Adana, Turkey, 1330

Istanbul University Faculty of Medicine

Istanbul, Turkey, 34093

Kocaeli University Hospital

Kocaeli, Turkey, 41380

Community Institution "Regional Children Clinical Hospital"

Dnipropetrovsk, Ukraine, 49100

Municipal Institution "Donetsk Regional Center of Mother and Child Care"

Donetsk, Ukraine, 83114

Lugansk Regional Childrens Clinical Hospital

Lugansk, Ukraine, 91016

Municipal Institution "Lviv City Clinical Childrens Hospital"

Lviv, Ukraine, 79059

Municipal Institution “Odesa Regional Children's Hospital”

Odesa, Ukraine, 65031

Vinnytsya Regional Children Clinical Hospital

Vinnytsya, Ukraine, 21018