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OpenTrials
Completed

NCT Number: NCT00666185

Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

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

Completed

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Key information

Conditions

Candidiasis, Oral Bacterial Infections and Mycoses Candidiasis Infections Mouth Diseases Mycoses Stomatognathic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Abadia Uberaba, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micafungin

Drug

IV

Other names: Mycamine, FK463

Fluconazole

Drug

IV

Other names: Diflucan

Primary outcomes

  1. Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy

    Time frame: End of Therapy

Secondary outcomes

  1. Clinical response at end of therapy of cleared or improved

    Time frame: End of Therapy

  2. Mucosal response at end of therapy of cleared or improved

    Time frame: End of Therapy

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Apr 24, 2008
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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