Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis

August 19, 2014 updated by: Astellas Pharma Inc

A Phase 3, Randomized, Double-Blind, Comparative Trial of Two Dosing Regimens of Micafungin (FK463) Versus Caspofungin for the Treatment of Esophageal Candidiasis

To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

454

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • 5 Sites
      • Cordoba, Argentina
      • Neuquen, Argentina
      • Santa Fe, Argentina
  • Brazil
      • Barretos, Brazil
      • Belo Horizonte, Brazil
        • 3 Sites
      • Boqueirao-Santos, Brazil
      • Campinas, Brazil
      • Curitiba, Brazil
        • 2 Sites
      • Nova Iguacu, Brazil
      • Parquelandia-Fortaleza, Brazil
      • Sao Paulo, Brazil
        • 7 Sites
  • Peru
      • Lima, Peru
        • 4 Sites
  • South Africa
      • Arcadia-Pretoria, South Africa
      • Benoni, South Africa
      • Bloemfontein, South Africa
        • 2 Sites
      • Cape Town, South Africa
      • Centurion, South Africa
      • Dundee, South Africa
      • Durban, South Africa
      • Hatfield-Pretoria, South Africa
      • Olifantsfontein, South Africa
      • Port Elizabeth, South Africa
        • 2 Sites
      • Potchefstroom, South Africa
      • Pretoria, South Africa
      • Pretoria West, South Africa
      • Reiger Park, South Africa
      • Richards Bay, South Africa
      • Somerset West, South Africa
    • Botswana
      • Gaborone, Botswana, South Africa
    • Nambia
      • Windoek, Nambia, South Africa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Esophageal candidiasis confirmed by endoscopy
  • Negative pregnancy test for female patients of childbearing potential

Exclusion Criteria:

  • Pregnant or nursing female patient
  • Evidence of liver disease
  • Another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
  • Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
  • Received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug
  • Known to be non-responsive to therapy in any prior systemic antifungal clinical trail
  • Experienced > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
  • History of anaphylaxis attributed to echinocandin class of antifungals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: caspofungin
IV
Experimental: 1
Daily dose
Drug: micafungin
IV
Other Names:
  • Mycamine
  • FK463
Experimental: 3
Every other day dose, alternating with placebo
Drug: micafungin
IV
Other Names:
  • Mycamine
  • FK463

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparative incidence of success, defined as complete clearing of esophageal lesions
Time Frame: End of Therapy
End of Therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall therapeutic response
Time Frame: End of Therapy
End of Therapy
Mycological response
Time Frame: End of Therapy
End of Therapy
Clinical response
Time Frame: End of Therapy
End of Therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-7-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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