Clinical trial NCT00815516: Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Candidiasis
Keywords: candidiasis
candida
Neonate
candidemia
Micafungin
Mycamine
amphotericin B deoxycholate
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 48
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Neonates and young infants will be stratified by estimated gestational age and by world region

Eligibility 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 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.

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 (unless obtained at the time the indwelling catheter was placed) or sputum.
* Infant previously enrolled in this study

Primary outcomes:
measure: Fungal-free Survival
timeFrame: One week after the last dose of study drug (maximum of 49 days)
Secondary outcomes:
measure: Time to Mycological Clearance of Invasive Candidiasis
timeFrame: From first dose up to 30 days after the last dose of study drug (maximum of 72 days)
measure: Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination
timeFrame: The end of study drug therapy; maximum of 42 days
measure: Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination
timeFrame: One week after the last dose of study drug (maximum of 49 days)
measure: Percentage of Participants With Emergent Fungal Infections
timeFrame: Up to 30 days after the last dose of study drug (maximum of 72 days)
measure: Percentage of Participants With Recurrent Fungal Infections
timeFrame: Up to 30 days after the last dose of study drug (maximum of 72 days)
measure: Time to Positive Clinical Response
timeFrame: From first dose up to 30 days after the last dose of study drug (maximum of 72 days)
measure: Clinical Response at the End of Study Drug Therapy
timeFrame: Baseline and end of study drug therapy; maximum of 42 days
measure: Clinical Response One Week After Last Dose of Study Drug
timeFrame: Baseline and one week after the last dose of study drug (maximum of 49 days)
measure: Mycological Response at End of Study Drug Therapy
timeFrame: End of study drug therapy; maximum of 42 days
measure: Mycological Response One Week After Last Dose of Study Drug
timeFrame: One week after the last dose of study drug (maximum of 49 days)
measure: Follow-up Status for Infants With End-organ Assessments
timeFrame: Baseline and 30 days after the last dose of study drug (maximum of 72 days)
measure: Plasma Micafungin Concentration
timeFrame: 15 minutes post intravenous infusion (IV), 4-8 hours post IV and 15-24 hours post IV
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: New Brunswick
country: United States
facility: UMDNJ/Robert Wood Johnson Medical School
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Health and Hospitals
state: North Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Belo Horizonte
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Belo Horizonte
state: Minas Gerais
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base da Faculdade de Medicina
state: Sao Paulo
city: Sofia
country: Bulgaria
facility: Spec Hospital for Active Treatment of Children Diseases
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioque
city: Patras
country: Greece
facility: University Hospital of Patras
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Cluj-Napoca
country: Romania
facility: Emergency County Clinical Hospital
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty
city: Odesa
country: Ukraine
facility: Municipal Institution "Odesa Regional Children's Hospital"
Study officials:
affiliation: Astellas Pharma Global Development
name: Senior Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.