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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00665639

Collaborator

(none)

454

Enrollment

Locations

Arms

Duration (Months)

14.6

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Oral	Drug: micafungin Drug: caspofungin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

454 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Daily dose	Drug: micafungin IV Other Names: Mycamine FK463
Active Comparator: 2	Drug: caspofungin IV
Experimental: 3 Every other day dose, alternating with placebo	Drug: micafungin IV Other Names: Mycamine FK463

Arm

Intervention/Treatment

Experimental: 1

Daily dose

Drug: micafungin

Other Names:

Mycamine

FK463

Active Comparator: 2

Drug: caspofungin

Experimental: 3

Every other day dose, alternating with placebo

Drug: micafungin

Other Names:

Mycamine

FK463

Outcome Measures

Primary Outcome Measures

Comparative incidence of success, defined as complete clearing of esophageal lesions [End of Therapy]

Secondary Outcome Measures

Overall therapeutic response [End of Therapy]
Mycological response [End of Therapy]
Clinical response [End of Therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	5 Sites	Buenos Aires		Argentina
2		Cordoba		Argentina
3		Neuquen		Argentina
4		Santa Fe		Argentina
5		Barretos		Brazil
6	3 Sites	Belo Horizonte		Brazil
7		Boqueirao-Santos		Brazil
8		Campinas		Brazil
9	2 Sites	Curitiba		Brazil
10		Nova Iguacu		Brazil
11		Parquelandia-Fortaleza		Brazil
12	7 Sites	Sao Paulo		Brazil
13	4 Sites	Lima		Peru
14		Gaborone	Botswana	South Africa
15		Windoek	Nambia	South Africa
16		Arcadia-Pretoria		South Africa
17		Benoni		South Africa
18	2 Sites	Bloemfontein		South Africa
19		Cape Town		South Africa
20		Centurion		South Africa
21		Dundee		South Africa
22		Durban		South Africa
23		Hatfield-Pretoria		South Africa
24		Olifantsfontein		South Africa
25	2 Sites	Port Elizabeth		South Africa
26		Potchefstroom		South Africa
27		Pretoria West		South Africa
28		Pretoria		South Africa
29		Reiger Park		South Africa
30		Richards Bay		South Africa
31		Somerset West		South Africa