Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

This study has been completed.

First Received: April 22, 2008 Last Updated: June 26, 2008 History of Changes

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00666185

Purpose

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

Condition	Intervention	Phase
Candidiasis, Oral	Drug: Micafungin Drug: Fluconazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders Yeast Infections

Drug Information available for: Fluconazole FK 463 Micafungin

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response at end of therapy of cleared or improved [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]
Mucosal response at end of therapy of cleared or improved [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Enrollment:	523
Study Start Date:	August 2003
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Micafungin IV
2: Active Comparator	Drug: Fluconazole IV

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666185

Locations

Brazil
2 Sites
Curitiba, Brazil
2 Sites
Campinas, Brazil
5 Sites
Belo Horizonte, Brazil

Nova Iguacu, Brazil
8 Sites
Sao Paulo, Brazil

Porto Alegre, Brazil

Parquelandia - Fortaleza, Brazil
4 Sites
Rio de Janeiro, Brazil

Boqueirao - Santos, Brazil

Maruipe Victoria, Brazil

Goiania, Brazil
2 Sites
Salvador, Brazil

Barretos, Brazil

Sao Jose do Rio Preto, Brazil

Quinta - Natal, Brazil

Abadia Uberaba, Brazil
Peru
4 Sites
Lima, Peru
South Africa
3 Sites
Pretoria, South Africa

Westdene - Bloemfontein, South Africa

Centurion, South Africa

Paarl, South Africa

Johannesburg, South Africa

Arcadia-Pretoria, South Africa

Pretoria West, South Africa

Cape Town, South Africa

Richards Bay, South Africa
2 Sites
Bloemfontein, South Africa

Olifantsfontein, South Africa

Bellville - Cape Town, South Africa

Dundee, South Africa

Potchefstroom, South Africa

Reiger Park, South Africa

Brits, South Africa

Somerset West, South Africa

Hatfield - Pretoria, South Africa
2 Sites
Port Elizabeth, South Africa
2 Sites
Durban, South Africa

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use central contact

Astellas Pharma US, Inc.

More Information

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	03-7-005
Study First Received:	April 22, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00666185 History of Changes
Health Authority:	South Africa: National Health Research Ethics Council; Peru: Ethics Committee; Brazil: National Committee of Ethics in Research

Keywords provided by Astellas Pharma Inc:

Micafungin
Esophageal Candidiasis
Fluconazole

Study placed in the following topic categories:

Fluconazole
Mouth Diseases
Mycoses
Candidiasis, Oral
Candidiasis

Esophageal Disorder
Antifungal Agents
Stomatognathic Diseases
Esophageal Diseases
Micafungin

Additional relevant MeSH terms:

Fluconazole
Mouth Diseases
Anti-Infective Agents
Mycoses
Candidiasis, Oral
Candidiasis

Therapeutic Uses
Antifungal Agents
Stomatognathic Diseases
Pharmacologic Actions
Micafungin

ClinicalTrials.gov processed this record on July 02, 2009