Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Last updated: September 17, 2014
Sponsor: Astellas Pharma Inc
Overall Status: Completed

Phase

3

Condition

Oral Candidiasis

Yeast Infections

Systemic Fungal Infections

Treatment

N/A

Clinical Study ID

NCT00666185
03-7-005
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of esophageal candidiasis confirmed by endoscopy

  • Negative pregnancy test in females of childbearing potential

Exclusion

Exclusion Criteria:

  • Pregnant or nursing

  • Evidence of liver disease

  • Presence of another active opportunistic fungal infection and/or receiving acutesystemic 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 agentwithin 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 antifungaltherapy

  • History of anaphylaxis attributed to azole compounds or echinocandin class ofantifungals

Study Design

Total Participants: 523
Study Start date:
August 01, 2003
Estimated Completion Date:
February 29, 2004

Connect with a study center

  • Abadia Uberaba,
    Brazil

    Site Not Available

  • Barretos,
    Brazil

    Site Not Available

  • 5 Sites

    Belo Horizonte,
    Brazil

    Site Not Available

  • Boqueirao - Santos,
    Brazil

    Site Not Available

  • 2 Sites

    Campinas,
    Brazil

    Site Not Available

  • 2 Sites

    Curitiba,
    Brazil

    Site Not Available

  • Goiania,
    Brazil

    Site Not Available

  • Maruipe Victoria,
    Brazil

    Site Not Available

  • Nova Iguacu,
    Brazil

    Site Not Available

  • Parquelandia - Fortaleza,
    Brazil

    Site Not Available

  • Porto Alegre,
    Brazil

    Site Not Available

  • Quinta - Natal,
    Brazil

    Site Not Available

  • 4 Sites

    Rio de Janeiro,
    Brazil

    Site Not Available

  • 2 Sites

    Salvador,
    Brazil

    Site Not Available

  • Sao Jose do Rio Preto,
    Brazil

    Site Not Available

  • Sao Jose do Rio Preto,
    Brazil

    Site Not Available

  • 8 Sites

    Sao Paulo,
    Brazil

    Site Not Available

  • 4 Sites

    Lima,
    Peru

    Site Not Available

  • Arcadia-Pretoria,
    South Africa

    Site Not Available

  • Bellville - Cape Town,
    South Africa

    Site Not Available

  • 2 Sites

    Bloemfontein,
    South Africa

    Site Not Available

  • Brits,
    South Africa

    Site Not Available

  • Cape Town,
    South Africa

    Site Not Available

  • Centurion,
    South Africa

    Site Not Available

  • Dundee,
    South Africa

    Site Not Available

  • 2 Sites

    Durban,
    South Africa

    Site Not Available

  • Hatfield - Pretoria,
    South Africa

    Site Not Available

  • Johannesburg,
    South Africa

    Site Not Available

  • Olifantsfontein,
    South Africa

    Site Not Available

  • Paarl,
    South Africa

    Site Not Available

  • 2 Sites

    Port Elizabeth,
    South Africa

    Site Not Available

  • Potchefstroom,
    South Africa

    Site Not Available

  • 3 Sites

    Pretoria,
    South Africa

    Site Not Available

  • Pretoria West,
    South Africa

    Site Not Available

  • Reiger Park,
    South Africa

    Site Not Available

  • Richards Bay,
    South Africa

    Site Not Available

  • Somerset West,
    South Africa

    Site Not Available

  • Westdene - Bloemfontein,
    South Africa

    Site Not Available

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