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

NCT00815516 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-11-04

Study results available
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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

Interventions

DRUG

micafungin

Administered by intravenous infusion

DRUG

amphotericin B deoxycholate

Administered by intravenous infusion

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Senior Medical Director · Astellas Pharma Global Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
48 Hours
Max Age
120 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Greece
  • Hungary
  • Israel
  • Philippines
  • Romania
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815516 on ClinicalTrials.gov