Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis

Condition(s) targeted: Candidiasis, Oral

Intervention: micafungin (Drug); caspofungin (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 daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis

Official title: A Phase 3, Randomized, Double-Blind, Comparative Trial of Two Dosing Regimens of Micafungin (FK463) Versus Caspofungin for the Treatment of Esophageal Candidiasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Comparative incidence of success, defined as complete clearing of esophageal lesions

Secondary outcome:

Overall therapeutic response

Mycological response

Clinical response

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

Criteria:

Inclusion Criteria:

- Esophageal candidiasis confirmed by endoscopy

- Negative pregnancy test for female patients of childbearing potential

Exclusion Criteria:

- Pregnant or nursing female patient

- Evidence of liver disease

- 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

- Received an oral or topical antifungal agent within 48 hours or a systemic antifungal

agent within 72 hours of first dose of study drug

- Known to be non-responsive to therapy in any prior systemic antifungal clinical trail

- Experienced > 2 episodes of esophageal candidiasis requiring systemic antifungal

therapy

- History of anaphylaxis attributed to echinocandin class of antifungals

5 Sites, Buenos Aires, Argentina

Cordoba, Argentina

Neuquen, Argentina

Santa Fe, Argentina

Barretos, Brazil

3 Sites, Belo Horizonte, Brazil

Boqueirao-Santos, Brazil

Campinas, Brazil

2 Sites, Curitiba, Brazil

Nova Iguacu, Brazil

Parquelandia-Fortaleza, Brazil

7 Sites, Sao Paulo, Brazil

4 Sites, Lima, Peru

Arcadia-Pretoria, South Africa

Benoni, South Africa

2 Sites, Bloemfontein, South Africa

Cape Town, South Africa

Centurion, South Africa

Dundee, South Africa

Durban, South Africa

Hatfield-Pretoria, South Africa

Olifantsfontein, South Africa

2 Sites, Port Elizabeth, South Africa

Potchefstroom, South Africa

Pretoria West, South Africa

Pretoria, South Africa

Reiger Park, South Africa

Richards Bay, South Africa

Somerset West, South Africa

Gaborone, Botswana, South Africa

Windoek, Nambia, South Africa

Link to Results on JAPIC - enter 140539 in the JapicCTI-RNo. field

Starting date: June 2004
Last updated: August 19, 2014