Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Condition(s) targeted: Candidiasis, Oral

Intervention: Micafungin (Drug); Fluconazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use central contact, Study Director, Affiliation: Astellas Pharma US, Inc.

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy

Secondary outcome:

Clinical response at end of therapy of cleared or improved

Mucosal response at end of therapy of cleared or improved

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

2 Sites, Curitiba, Brazil

2 Sites, Campinas, Brazil

5 Sites, Belo Horizonte, Brazil

Nova Iguacu, Brazil

4 Sites, Rio de Janeiro, Brazil

Porto Alegre, Brazil

Parquelandia - Fortaleza, Brazil

8 Sites, Sao Paulo, 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

4 Sites, Lima, Peru

3 Sites, Pretoria, South Africa

2 Sites, Durban, 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

Westdene - Bloemfontein, South Africa

Starting date: August 2003
Ending date: February 2004
Last updated: April 23, 2008