Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00666185

Collaborator

(none)

523

Enrollment

Locations

Arms

Duration (Months)

14.1

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Oral	Drug: Micafungin Drug: Fluconazole	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

523 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 Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Micafungin IV Other Names: Mycamine FK463
Active Comparator: 2	Drug: Fluconazole IV Other Names: Diflucan

Arm

Intervention/Treatment

Experimental: 1

Drug: Micafungin

Other Names:

Mycamine

FK463

Active Comparator: 2

Drug: Fluconazole

Other Names:

Diflucan

Outcome Measures

Primary Outcome Measures

Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy [End of Therapy]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1		Abadia Uberaba	Brazil
2		Barretos	Brazil
3	5 Sites	Belo Horizonte	Brazil
4		Boqueirao - Santos	Brazil
5	2 Sites	Campinas	Brazil
6	2 Sites	Curitiba	Brazil
7		Goiania	Brazil
8		Maruipe Victoria	Brazil
9		Nova Iguacu	Brazil
10		Parquelandia - Fortaleza	Brazil
11		Porto Alegre	Brazil
12		Quinta - Natal	Brazil
13	4 Sites	Rio de Janeiro	Brazil
14	2 Sites	Salvador	Brazil
15		Sao Jose do Rio Preto	Brazil
16	8 Sites	Sao Paulo	Brazil
17	4 Sites	Lima	Peru
18		Arcadia-Pretoria	South Africa
19		Bellville - Cape Town	South Africa
20	2 Sites	Bloemfontein	South Africa
21		Brits	South Africa
22		Cape Town	South Africa
23		Centurion	South Africa
24		Dundee	South Africa
25	2 Sites	Durban	South Africa
26		Hatfield - Pretoria	South Africa
27		Johannesburg	South Africa
28		Olifantsfontein	South Africa
29		Paarl	South Africa
30	2 Sites	Port Elizabeth	South Africa
31		Potchefstroom	South Africa
32		Pretoria West	South Africa
33	3 Sites	Pretoria	South Africa
34		Reiger Park	South Africa
35		Richards Bay	South Africa
36		Somerset West	South Africa
37		Westdene - Bloemfontein	South Africa