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

Primary Purpose

Candidiasis, Oral

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
micafungin
caspofungin
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Oral focused on measuring Micafungin, Esophageal Candidiasis, caspofungin

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 5 Sites
  • 3 Sites
  • 2 Sites
  • 7 Sites
  • 4 Sites
  • 2 Sites
  • 2 Sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Daily dose

Every other day dose, alternating with placebo

Outcomes

Primary Outcome Measures

Comparative incidence of success, defined as complete clearing of esophageal lesions

Secondary Outcome Measures

Overall therapeutic response
Mycological response
Clinical response

Full Information

First Posted
April 22, 2008
Last Updated
August 19, 2014
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00665639
Brief Title
Trial of Two Dosing Regimens of Micafungin Versus 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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral
Keywords
Micafungin, Esophageal Candidiasis, caspofungin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Daily dose
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Experimental
Arm Description
Every other day dose, alternating with placebo
Intervention Type
Drug
Intervention Name(s)
micafungin
Other Intervention Name(s)
Mycamine, FK463
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
caspofungin
Intervention Description
IV
Primary Outcome Measure Information:
Title
Comparative incidence of success, defined as complete clearing of esophageal lesions
Time Frame
End of Therapy
Secondary Outcome Measure Information:
Title
Overall therapeutic response
Time Frame
End of Therapy
Title
Mycological response
Time Frame
End of Therapy
Title
Clinical response
Time Frame
End of Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use central contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
5 Sites
City
Buenos Aires
Country
Argentina
City
Cordoba
Country
Argentina
City
Neuquen
Country
Argentina
City
Santa Fe
Country
Argentina
City
Barretos
Country
Brazil
Facility Name
3 Sites
City
Belo Horizonte
Country
Brazil
City
Boqueirao-Santos
Country
Brazil
City
Campinas
Country
Brazil
Facility Name
2 Sites
City
Curitiba
Country
Brazil
City
Nova Iguacu
Country
Brazil
City
Parquelandia-Fortaleza
Country
Brazil
Facility Name
7 Sites
City
Sao Paulo
Country
Brazil
Facility Name
4 Sites
City
Lima
Country
Peru
City
Gaborone
State/Province
Botswana
Country
South Africa
City
Windoek
State/Province
Nambia
Country
South Africa
City
Arcadia-Pretoria
Country
South Africa
City
Benoni
Country
South Africa
Facility Name
2 Sites
City
Bloemfontein
Country
South Africa
City
Cape Town
Country
South Africa
City
Centurion
Country
South Africa
City
Dundee
Country
South Africa
City
Durban
Country
South Africa
City
Hatfield-Pretoria
Country
South Africa
City
Olifantsfontein
Country
South Africa
Facility Name
2 Sites
City
Port Elizabeth
Country
South Africa
City
Potchefstroom
Country
South Africa
City
Pretoria West
Country
South Africa
City
Pretoria
Country
South Africa
City
Reiger Park
Country
South Africa
City
Richards Bay
Country
South Africa
City
Somerset West
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
23959319
Citation
Andes DR, Reynolds DK, Van Wart SA, Lepak AJ, Kovanda LL, Bhavnani SM. Clinical pharmacodynamic index identification for micafungin in esophageal candidiasis: dosing strategy optimization. Antimicrob Agents Chemother. 2013 Nov;57(11):5714-6. doi: 10.1128/AAC.01057-13. Epub 2013 Aug 19.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140539 in the JapicCTI-RNo. field

Learn more about this trial

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

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