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

NCT00815516 | Terminated Phase 3 Results DMC

• 2 other identifiers: 9463-CL-23032012-000780-24
• Study Type: interventional
• Target: 30
• Locations: 12 countries
• Sites: 17

Brief Summary

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.

Conditions

Candidiasis

Keywords

candidiasis; candida; Neonate; candidemia; Micafungin; Mycamine; amphotericin B deoxycholate

Outcome Measures

Primary Outcomes (1)

• Fungal-free Survival

  Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at one week following the last dose of study drug with a mycological response of eradication and no requirement for alternative systemic antifungal therapy for continued treatment. Eradication was defined as culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for Candida meningitis and/or candiduria, 1 negative culture.

  One week after the last dose of study drug (maximum of 49 days)

Secondary Outcomes (12)

• Time to Mycological Clearance of Invasive Candidiasis

  From first dose up to 30 days after the last dose of study drug (maximum of 72 days)

• Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination

  The end of study drug therapy; maximum of 42 days

• Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination

  One week after the last dose of study drug (maximum of 49 days)

• Percentage of Participants With Emergent Fungal Infections

  Up to 30 days after the last dose of study drug (maximum of 72 days)

• Percentage of Participants With Recurrent Fungal Infections

  Up to 30 days after the last dose of study drug (maximum of 72 days)

Study Arms (2)

Micafungin

EXPERIMENTAL

Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.

Drug: micafungin

Amphotericin B deoxycholate

ACTIVE COMPARATOR

Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.

Drug: amphotericin B deoxycholate

Interventions

micafungin DRUG

Administered by intravenous infusion

Also known as: Mycamine, FK463

Micafungin

amphotericin B deoxycholate DRUG

Administered by intravenous infusion

Also known as: Fungizone, Conventional amphotericin B (CAB), Amphotericin B for injection

Amphotericin B deoxycholate

Eligibility Criteria

• Age: 48 Hours - 120 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (17)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

UMDNJ/Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

WakeMed Health and Hospitals

Raleigh, North Carolina, 27610, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Irmandade da Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Hospital de Base da Faculdade de Medicina

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Spec Hospital for Active Treatment of Children Diseases

Sofia, 1606, Bulgaria

Location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hospital Pablo Tobon Uribe

Medellín, Antioque, 574, Colombia

Location

University Hospital of Patras

Pátrai, 26504, Greece

Location

Semmelweis Egyetem

Budapest, 8200, Hungary

Location

Hadassah University Hospital Ein Kerem

Jerusalem, 91120, Israel

Location

Philippine General Hospital

Manila, Philippines

Location

Emergency County Clinical Hospital

Cluj-Napoca, 400006, Romania

Location

Cukurova University Medical Faculty

Adana, 1330, Turkey (Türkiye)

Location

Municipal Institution "Odesa Regional Children's Hospital"

Odesa, 65031, Ukraine

Location

Related Publications (1)

• Benjamin DK Jr, Kaufman DA, Hope WW, Smith PB, Arrieta A, Manzoni P, Kovanda LL, Lademacher C, Isaacson B, Jednachowski D, Wu C, Kaibara A, Walsh TJ. A Phase 3 Study of Micafungin Versus Amphotericin B Deoxycholate in Infants With Invasive Candidiasis. Pediatr Infect Dis J. 2018 Oct;37(10):992-998. doi: 10.1097/INF.0000000000001996.

  PMID: 29596222 DERIVED

Related Links

• Link to results on Astellas Clinical Study Results Web site

MeSH Terms

Conditions

Candidiasis; Torulopsis; Candidemia

Interventions

Micafungin; amphotericin B, deoxycholate drug combination; Amphotericin B; Injections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Candidiasis, Invasive; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Macrolides; Polyketides; Lactones; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Senior Medical Director, Global Medical Science
• Organization: Astellas Pharma Global Development, Inc. (APGD)

Astellas.resultsdisclosure@astellas.com

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2008
• First Posted: December 30, 2008
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 4, 2015
• Results First Posted: September 15, 2015

Record last verified: 2015-10

Locations

RO (1); HU (1); CA (1); CO (1); TU (1); UA (1); GR (1); US (5); BU (1); IL (1); BR (2); PH (1)