NCT00815516: MAGIC-2

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

Terminated Phase 3 Results posted Last updated 12 October 2015

What this trial tests

Phase 3 trial testing micafungin in Candidiasis in 30 participants. Terminated before completion.

Timeline

1 February 2013

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	1 February 2013
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	17 locations across United States, Brazil, Bulgaria, Canada, Colombia, Greece, Hungary, Israel

Drugs / interventions tested

• micafungin (MICAFUNGIN) — full drug profile →
• amphotericin B deoxycholate — full drug profile →

Conditions studied

• Candidiasis — all drugs for Candidiasis →

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

Adults 48 Hours to 120 Days, any sex, with Candidiasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Fungal-free Survival
  Time frame: One week after the last dose of study drug (maximum of 49 days)
  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 absen

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacokinetics and pharmacodynamics of antifungals in children: clinical implications.
   Autmizguine J, Guptill JT, Cohen-Wolkowiez M, Benjamin DK, et al · · 2014 · cited 40× · PMID 24872147 · DOI 10.1007/s40265-014-0227-3
2. A Phase 3 Study of Micafungin Versus Amphotericin B Deoxycholate in Infants With Invasive Candidiasis.
   Benjamin DK, Kaufman DA, Hope WW, Smith PB, et al · · 2018 · cited 26× · PMID 29596222 · DOI 10.1097/inf.0000000000001996
3. High-Dose Micafungin for Preterm Neonates and Infants with Invasive and Central Nervous System Candidiasis.
   Auriti C, Falcone M, Ronchetti MP, Goffredo BM, et al · · 2016 · cited 26× · PMID 27697761 · DOI 10.1128/aac.01172-16
4. Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.
   Leroux S, Jacqz-Aigrain E, Elie V, Legrand F, et al · · 2018 · cited 25× · PMID 29744900 · DOI 10.1111/bcp.13628
5. Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.
   Hope WW, Kaibara A, Roy M, Arrieta A, et al · · 2015 · cited 25× · PMID 25421470 · DOI 10.1128/aac.03736-14
6. Advances in the treatment of invasive neonatal candidiasis.
   Botero-Calderon L, Benjamin DK, Cohen-Wolkowiez M. · · 2015 · cited 18× · PMID 25842986 · DOI 10.1517/14656566.2015.1031108
7. Severe Congenital Candidiasis due to <i>Candida dubliniensis</i> Treated With Fosfluconazole in a Preterm Infant.
   Higashiyama H, Futatani T. · · 2026 · PMID 42052328 · DOI 10.1155/crpe/7680042