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Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Primary Purpose

Candidiasis, Oral

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Micafungin
Fluconazole
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, Fluconazole

Eligibility Criteria

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

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

Sites / Locations

  • 5 Sites
  • 2 Sites
  • 2 Sites
  • 4 Sites
  • 2 Sites
  • 8 Sites
  • 4 Sites
  • 2 Sites
  • 2 Sites
  • 2 Sites
  • 3 Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical response at end of therapy of cleared or improved
Mucosal response at end of therapy of cleared or improved

Full Information

First Posted
April 22, 2008
Last Updated
September 17, 2014
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00666185
Brief Title
Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis
Official Title
A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 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 IV Micafungin versus IV Fluconazole in the treatment of patients with 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, Fluconazole

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
Mycamine, FK463
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
Diflucan
Intervention Description
IV
Primary Outcome Measure Information:
Title
Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy
Time Frame
End of Therapy
Secondary Outcome Measure Information:
Title
Clinical response at end of therapy of cleared or improved
Time Frame
End of Therapy
Title
Mucosal response at end of therapy of cleared or improved
Time Frame
End of Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
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:
City
Abadia Uberaba
Country
Brazil
City
Barretos
Country
Brazil
Facility Name
5 Sites
City
Belo Horizonte
Country
Brazil
City
Boqueirao - Santos
Country
Brazil
Facility Name
2 Sites
City
Campinas
Country
Brazil
Facility Name
2 Sites
City
Curitiba
Country
Brazil
City
Goiania
Country
Brazil
City
Maruipe Victoria
Country
Brazil
City
Nova Iguacu
Country
Brazil
City
Parquelandia - Fortaleza
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Quinta - Natal
Country
Brazil
Facility Name
4 Sites
City
Rio de Janeiro
Country
Brazil
Facility Name
2 Sites
City
Salvador
Country
Brazil
City
Sao Jose do Rio Preto
Country
Brazil
Facility Name
8 Sites
City
Sao Paulo
Country
Brazil
Facility Name
4 Sites
City
Lima
Country
Peru
City
Arcadia-Pretoria
Country
South Africa
City
Bellville - Cape Town
Country
South Africa
Facility Name
2 Sites
City
Bloemfontein
Country
South Africa
City
Brits
Country
South Africa
City
Cape Town
Country
South Africa
City
Centurion
Country
South Africa
City
Dundee
Country
South Africa
Facility Name
2 Sites
City
Durban
Country
South Africa
City
Hatfield - Pretoria
Country
South Africa
City
Johannesburg
Country
South Africa
City
Olifantsfontein
Country
South Africa
City
Paarl
Country
South Africa
Facility Name
2 Sites
City
Port Elizabeth
Country
South Africa
City
Potchefstroom
Country
South Africa
City
Pretoria West
Country
South Africa
Facility Name
3 Sites
City
Pretoria
Country
South Africa
City
Reiger Park
Country
South Africa
City
Richards Bay
Country
South Africa
City
Somerset West
Country
South Africa
City
Westdene - Bloemfontein
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
15801925
Citation
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. doi: 10.1111/j.1365-2036.2005.02427.x.
Results Reference
background
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 140575 in the JapicCTI-RNo. field

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Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

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