Clinical trial NCT00665639: Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidiasis, Oral
Keywords: Micafungin
Esophageal Candidiasis
caspofungin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 454
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Comparative incidence of success, defined as complete clearing of esophageal lesions
timeFrame: End of Therapy
Secondary outcomes:
measure: Overall therapeutic response
timeFrame: End of Therapy
measure: Mycological response
timeFrame: End of Therapy
measure: Clinical response
timeFrame: End of Therapy
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: 5 Sites
city: Cordoba
country: Argentina
city: Neuquen
country: Argentina
city: Santa Fe
country: Argentina
city: Barretos
country: Brazil
city: Belo Horizonte
country: Brazil
facility: 3 Sites
city: Boqueirao-Santos
country: Brazil
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
facility: 2 Sites
city: Nova Iguacu
country: Brazil
city: Parquelandia-Fortaleza
country: Brazil
city: Sao Paulo
country: Brazil
facility: 7 Sites
city: Lima
country: Peru
facility: 4 Sites
city: Gaborone
country: South Africa
state: Botswana
city: Windoek
country: South Africa
state: Nambia
city: Arcadia-Pretoria
country: South Africa
city: Benoni
country: South Africa
city: Bloemfontein
country: South Africa
facility: 2 Sites
city: Cape Town
country: South Africa
city: Centurion
country: South Africa
city: Dundee
country: South Africa
city: Durban
country: South Africa
city: Hatfield-Pretoria
country: South Africa
city: Olifantsfontein
country: South Africa
city: Port Elizabeth
country: South Africa
facility: 2 Sites
city: Potchefstroom
country: South Africa
city: Pretoria West
country: South Africa
city: Pretoria
country: South Africa
city: Reiger Park
country: South Africa
city: Richards Bay
country: South Africa
city: Somerset West
country: South Africa
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use central contact
role: STUDY_DIRECTOR
References:
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.