Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

NCT00666185 | Completed Phase 3

• 1 other identifier: 03-7-005
• Study Type: interventional
• Target: 523
• Locations: 3 countries
• Sites: 37

Brief Summary

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

Conditions

Candidiasis, Oral

Keywords

Micafungin; Esophageal Candidiasis; Fluconazole

Outcome Measures

Primary Outcomes (1)

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

  End of Therapy

Secondary Outcomes (2)

• Clinical response at end of therapy of cleared or improved

  End of Therapy

• Mucosal response at end of therapy of cleared or improved

  End of Therapy

Study Arms (2)

1

EXPERIMENTAL

Drug: Micafungin

2

ACTIVE COMPARATOR

Drug: Fluconazole

Interventions

Micafungin DRUG

IV

Also known as: Mycamine, FK463

1

Fluconazole DRUG

IV

Also known as: Diflucan

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of esophageal candidiasis confirmed by endoscopy
• Negative pregnancy test in females of childbearing potential

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (37)

Unknown Facility

Abadia Uberaba, Brazil

Location

Unknown Facility

Barretos, Brazil

Location

5 Sites

Belo Horizonte, Brazil

Location

Unknown Facility

Boqueirao - Santos, Brazil

Location

2 Sites

Campinas, Brazil

Location

2 Sites

Curitiba, Brazil

Location

Unknown Facility

Goiânia, Brazil

Location

Unknown Facility

Maruipe Victoria, Brazil

Location

Unknown Facility

Nova Iguaçu, Brazil

Location

Unknown Facility

Parquelandia - Fortaleza, Brazil

Location

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Quinta - Natal, Brazil

Location

4 Sites

Rio de Janeiro, Brazil

Location

2 Sites

Salvador, Brazil

Location

Unknown Facility

São José do Rio Preto, Brazil

Location

8 Sites

São Paulo, Brazil

Location

4 Sites

Lima, Peru

Location

Unknown Facility

Arcadia-Pretoria, South Africa

Location

Unknown Facility

Bellville - Cape Town, South Africa

Location

2 Sites

Bloemfontein, South Africa

Location

Unknown Facility

Brits, South Africa

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

Centurion, South Africa

Location

Unknown Facility

Dundee, South Africa

Location

2 Sites

Durban, South Africa

Location

Unknown Facility

Hatfield - Pretoria, South Africa

Location

Unknown Facility

Johannesburg, South Africa

Location

Unknown Facility

Olifantsfontein, South Africa

Location

Unknown Facility

Paarl, South Africa

Location

2 Sites

Port Elizabeth, South Africa

Location

Unknown Facility

Potchefstroom, South Africa

Location

3 Sites

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

Unknown Facility

Westdene - Bloemfontein, South Africa

Location

Related Publications (2)

• 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.

  PMID: 15801925 BACKGROUND

• 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: 23959319 DERIVED

MeSH Terms

Conditions

Candidiasis, Oral

Interventions

Micafungin; Fluconazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: August 1, 2003
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

ZA (20); PE (1); BR (16)