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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Candidia

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 Summary: Neonates and young infants will be stratified by estimated gestational age and by world region
Sponsor: Astellas Pharma Global Development, Inc.

Current Primary Outcome: Fungal-free Survival [ Time Frame: One week after the last dose of study drug (maximum of 49 days) ]

Original Primary Outcome: Fungal-free Survival [ Time Frame: Last dose + 1 week ]

Current Secondary Outcome:

• Time to Mycological Clearance of Invasive Candidiasis [ Time Frame: From first dose up to 30 days after the last dose of study drug (maximum of 72 days) ]

  Time to mycological clearance of invasive candidiasis is defined as the time from first dose to the day of mycological eradication for baseline invasive candidiasis infection.

  Eradication was defined as a 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 for Candida meningitis and/or candiduria, 1 negative culture.

  Infants without eradication during the treatment period and who survived were censored at one day after the end of treatment. Infants without eradication who died before completing the treatment period or were lost to follow-up during the treatment were censored at their death or last contact day.

• Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination [ Time Frame: The end of study drug therapy; maximum of 42 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 the end of study drug therapy with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.
• Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination [ 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 one week after last dose of study drug with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.
• Percentage of Participants With Emergent Fungal Infections [ Time Frame: Up to 30 days after the last dose of study drug (maximum of 72 days) ]

  An emergent fungal infection is defined as

  • An invasive fungal infection which is detected at any time during the study that is a non-Candida organism, or
  • An invasive fungal infection which is detected during the treatment or post-treatment period with a Candida species identified other than those detected at Baseline. If this occurred within 96 hours of the first dose of study drug, the infection was considered part of the final diagnosis of enrolling infection and not an emergent infection.
• Percentage of Participants With Recurrent Fungal Infections [ Time Frame: Up to 30 days after the last dose of study drug (maximum of 72 days) ]
  A recurrent infection is defined as a systemic fungal infection in an infant with eradication at the end of study drug therapy, who developed positive blood cultures or a mycologically confirmed deep-seated Candida infection, with the same species as the enrolling infection.
• Time to Positive Clinical Response [ Time Frame: From first dose up to 30 days after the last dose of study drug (maximum of 72 days) ]

  Time to a positive clinical response is defined as the time from the first dose to the day during the treatment period that a positive clinical response (defined as a complete response or partial response) is observed for the first time, assessed by the Investigator.

  Complete Response is defined as the resolution of all attributable signs related to fungal infection, if present at baseline and Partial Response is defined as improvement in attributable signs related to the fungal infection, if present at baseline.

  Infants without positive responses and who survived were censored at one day post the end of treatment. Infants without positive responses who died before completing the treatment period, or were lost to follow-up during the treatment were censored at their death or last contact day.

• Clinical Response at the End of Study Drug Therapy [ Time Frame: Baseline and end of study drug therapy; maximum of 42 days ]

  Clinical response assessments were based on the following definitions and assessed by the DRP:

  • Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.
  • Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.
  • Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without dete
    
    

    Original Secondary Outcome:
    
    Information By: Astellas Pharma Inc
    

    Dates:
    Date Received: December 27, 2008
    Date Started: February 2013
    Date Completion:
    Last Updated: October 12, 2015
    Last Verified: October 2015
    

  

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