Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

September 17, 2014 updated by: Astellas Pharma Inc

A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis

To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

523

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

  • Brazil
      • Abadia Uberaba, Brazil
      • Barretos, Brazil
      • Belo Horizonte, Brazil
        • 5 Sites
      • Boqueirao - Santos, Brazil
      • Campinas, Brazil
        • 2 Sites
      • Curitiba, Brazil
        • 2 Sites
      • Goiania, Brazil
      • Maruipe Victoria, Brazil
      • Nova Iguacu, Brazil
      • Parquelandia - Fortaleza, Brazil
      • Porto Alegre, Brazil
      • Quinta - Natal, Brazil
      • Rio de Janeiro, Brazil
        • 4 Sites
      • Salvador, Brazil
        • 2 Sites
      • Sao Jose do Rio Preto, Brazil
      • Sao Paulo, Brazil
        • 8 Sites
  • Peru
      • Lima, Peru
        • 4 Sites
  • South Africa
      • Arcadia-Pretoria, South Africa
      • Bellville - Cape Town, South Africa
      • Bloemfontein, South Africa
        • 2 Sites
      • Brits, South Africa
      • Cape Town, South Africa
      • Centurion, South Africa
      • Dundee, South Africa
      • Durban, South Africa
        • 2 Sites
      • Hatfield - Pretoria, South Africa
      • Johannesburg, South Africa
      • Olifantsfontein, South Africa
      • Paarl, South Africa
      • Port Elizabeth, South Africa
        • 2 Sites
      • Potchefstroom, South Africa
      • Pretoria, South Africa
        • 3 Sites
      • Pretoria West, South Africa
      • Reiger Park, South Africa
      • Richards Bay, South Africa
      • Somerset West, South Africa
      • Westdene - Bloemfontein, 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:

  • Diagnosis of esophageal candidiasis confirmed by endoscopy
  • Negative pregnancy test in females of childbearing potential

Exclusion Criteria:

  • Pregnant or nursing
  • Evidence of liver disease
  • Presence of 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
  • Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
  • Non-responsive to therapy in any prior systemic antifungal clinical trail
  • History of > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
  • History of anaphylaxis attributed to azole compounds or 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
Experimental: 1
Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463
Active Comparator: 2
Drug: Fluconazole
IV
Other Names:
  • Diflucan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy
Time Frame: End of Therapy
End of Therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical response at end of therapy of cleared or improved
Time Frame: End of Therapy
End of Therapy
Mucosal response at end of therapy of cleared or improved
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

August 1, 2003

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 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)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-7-005

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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