NCT00189709

Brief Summary

To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 2, 2008

Status Verified

December 1, 2007

Enrollment Period

1.9 years

First QC Date

September 12, 2005

Last Update Submit

December 26, 2007

Conditions

Invasive CandidiasisCandidemia

Keywords

micafunginfluconazoleinvasive candidiasiscandidemia

Outcome Measures

Primary Outcomes (1)

  • Response rate

    2-8 Weeks

Secondary Outcomes (1)

  • Clinical response, mycological response

    2-8 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Micafungin

2

ACTIVE COMPARATOR
Drug: fluconazole

Interventions

MicafunginDRUG

IV

Also known as: FK463
1
fluconazoleDRUG

IV

Also known as: Diflucan
2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a confirmed diagnosis of candidemia and invasive candidiasis
  • Patients could be newly diagnosed with candidiasis who received no more than 48 hours of prior systemic antifungal therapy
  • Inpatients aged 16 and above

You may not qualify if:

  • Patients with serious invasive candidiasis whose prognoses are considered to be poor (life expectancy judged to be less than 5 days).
  • Patients with severe complications in the liver
  • Pregnant or lactating women
  • Patients who have received at least 5 days of prior systemic treatment of fluconazole or echinocandin with no response.
  • Patients who have prior antifungal infection requiring treatment with systemic antifungal agents for conditions other than candidemia and invasive candidiasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Taipei, Republic of China, 100, Taiwan

Location

MeSH Terms

Conditions

Candidiasis, InvasiveCandidemia

Interventions

MicafunginFluconazole

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, CyclicTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Shan-Chwen Chang, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

August 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

January 2, 2008

Record last verified: 2007-12

Locations

TW(1)