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

Candidiasis, Oral Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665639
• Other study ID #: 03-7-008
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2008
• Last updated: August 19, 2014
• Start date: June 2004
• Est. completion date: December 2004

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics CouncilPeru: Ethics CommitteeBrazil: National Committee of Ethics in ResearchArgentina: Human Research Bioethics Committee
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral

Intervention

Drug:
• micafungin
IV
• caspofungin
IV

Locations

Country	Name	City	State
Argentina	5 Sites	Buenos Aires
Brazil	3 Sites	Belo Horizonte
Brazil	2 Sites	Curitiba
Brazil	7 Sites	Sao Paulo
Peru	4 Sites	Lima
South Africa	2 Sites	Bloemfontein
South Africa	2 Sites	Port Elizabeth

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Argentina,  Brazil,  Peru,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative incidence of success, defined as complete clearing of esophageal lesions		End of Therapy	No
Secondary	Overall therapeutic response		End of Therapy	No
Secondary	Mycological response		End of Therapy	No
Secondary	Clinical response		End of Therapy	No

External Links

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