Clinical trial NCT00666185: Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis
Official title: A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidiasis, Oral
Keywords: Micafungin
Esophageal Candidiasis
Fluconazole
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 523
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 IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis


Eligibility criteria: 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

Primary outcomes:
measure: Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy
timeFrame: End of Therapy
Secondary outcomes:
measure: Clinical response at end of therapy of cleared or improved
timeFrame: End of Therapy
measure: Mucosal response at end of therapy of cleared or improved
timeFrame: End of Therapy
Other outcomes:
Locations:
city: Abadia Uberaba
country: Brazil
city: Barretos
country: Brazil
city: Belo Horizonte
country: Brazil
facility: 5 Sites
city: Boqueirao - Santos
country: Brazil
city: Campinas
country: Brazil
facility: 2 Sites
city: Curitiba
country: Brazil
facility: 2 Sites
city: Goiania
country: Brazil
city: Maruipe Victoria
country: Brazil
city: Nova Iguacu
country: Brazil
city: Parquelandia - Fortaleza
country: Brazil
city: Porto Alegre
country: Brazil
city: Quinta - Natal
country: Brazil
city: Rio de Janeiro
country: Brazil
facility: 4 Sites
city: Salvador
country: Brazil
facility: 2 Sites
city: Sao Jose do Rio Preto
country: Brazil
city: Sao Paulo
country: Brazil
facility: 8 Sites
city: Lima
country: Peru
facility: 4 Sites
city: Arcadia-Pretoria
country: South Africa
city: Bellville - Cape Town
country: South Africa
city: Bloemfontein
country: South Africa
facility: 2 Sites
city: Brits
country: South Africa
city: Cape Town
country: South Africa
city: Centurion
country: South Africa
city: Dundee
country: South Africa
city: Durban
country: South Africa
facility: 2 Sites
city: Hatfield - Pretoria
country: South Africa
city: Johannesburg
country: South Africa
city: Olifantsfontein
country: South Africa
city: Paarl
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
facility: 3 Sites
city: Reiger Park
country: South Africa
city: Richards Bay
country: South Africa
city: Somerset West
country: South Africa
city: Westdene - Bloemfontein
country: South Africa
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use central contact
role: STUDY_DIRECTOR
References:
citation: 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.
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.