Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Candidiasis, Oral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666185
• Other study ID #: 03-7-005
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2008
• Last updated: September 17, 2014
• Start date: August 2003
• Est. completion date: February 2004

Study information

• Verified date: September 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 Research
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

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
• Fluconazole
IV

Locations

Country	Name	City	State
Brazil	5 Sites	Belo Horizonte
Brazil	2 Sites	Campinas
Brazil	2 Sites	Curitiba
Brazil	4 Sites	Rio de Janeiro
Brazil	2 Sites	Salvador
Brazil	8 Sites	Sao Paulo
Peru	4 Sites	Lima
South Africa	2 Sites	Bloemfontein
South Africa	2 Sites	Durban
South Africa	2 Sites	Port Elizabeth
South Africa	3 Sites	Pretoria

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Brazil,  Peru,  South Africa, 

References & Publications (1)

de Wet NT, Bester AJ, Viljoen JJ, Filho F, Suleiman JM, Ticona E, Llanos EA, Fisco C, Lau W, Buell D. A randomized, double blind, comparative trial of micafungin (FK463) vs. fluconazole for the treatment of oesophageal candidiasis. Aliment Pharmacol Ther. 2005 Apr 1;21(7):899-907. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy		End of Therapy	No
Secondary	Clinical response at end of therapy of cleared or improved		End of Therapy	No
Secondary	Mucosal response at end of therapy of cleared or improved		End of Therapy	No

External Links

•   Link to Results on JAPIC - enter 140575 in the JapicCTI-RNo. field