NCT00665639

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_3

Geographic Reach
4 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

6 months

First QC Date

April 22, 2008

Last Update Submit

August 19, 2014

Conditions

Candidiasis, Oral

Keywords

MicafunginEsophageal Candidiasiscaspofungin

Outcome Measures

Primary Outcomes (1)

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

    End of Therapy

Secondary Outcomes (3)

  • Overall therapeutic response

    End of Therapy

  • Mycological response

    End of Therapy

  • Clinical response

    End of Therapy

Study Arms (3)

1

EXPERIMENTAL

Daily dose

Drug: micafungin

2

ACTIVE COMPARATOR
Drug: caspofungin

3

EXPERIMENTAL

Every other day dose, alternating with placebo

Drug: micafungin

Interventions

micafunginDRUG

IV

Also known as: Mycamine, FK463
13
caspofunginDRUG

IV

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Esophageal candidiasis confirmed by endoscopy
  • Negative pregnancy test for female patients of childbearing potential

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

5 Sites

Buenos Aires, Argentina

Location

Unknown Facility

Córdoba, Argentina

Location

Unknown Facility

Neuquén, Argentina

Location

Unknown Facility

Santa Fe, Argentina

Location

Unknown Facility

Barretos, Brazil

Location

3 Sites

Belo Horizonte, Brazil

Location

Unknown Facility

Boqueirao-Santos, Brazil

Location

Unknown Facility

Campinas, Brazil

Location

2 Sites

Curitiba, Brazil

Location

Unknown Facility

Nova Iguaçu, Brazil

Location

Unknown Facility

Parquelandia-Fortaleza, Brazil

Location

7 Sites

São Paulo, Brazil

Location

4 Sites

Lima, Peru

Location

Unknown Facility

Gaborone, Botswana, South Africa

Location

Unknown Facility

Windoek, Nambia, South Africa

Location

Unknown Facility

Arcadia-Pretoria, South Africa

Location

Unknown Facility

Benoni, South Africa

Location

2 Sites

Bloemfontein, South Africa

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

Centurion, South Africa

Location

Unknown Facility

Dundee, South Africa

Location

Unknown Facility

Durban, South Africa

Location

Unknown Facility

Hatfield-Pretoria, South Africa

Location

Unknown Facility

Olifantsfontein, South Africa

Location

2 Sites

Port Elizabeth, South Africa

Location

Unknown Facility

Potchefstroom, South Africa

Location

Unknown Facility

Pretoria, South Africa

Location

Unknown Facility

Pretoria West, South Africa

Location

Unknown Facility

Reiger Park, South Africa

Location

Unknown Facility

Richards Bay, South Africa

Location

Unknown Facility

Somerset West, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 23959319DERIVED

MeSH Terms

Conditions

Candidiasis, Oral

Interventions

MicafunginCaspofungin

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Use central contact

    Astellas Pharma US, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

June 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

ZA(18)PE(1)AR(4)BR(8)