Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations (ICE)

NCT00689338 Phase 3 COMPLETED Results posted

To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Details

Lead sponsor	Pfizer
Phase	Phase 3
Status	COMPLETED
Enrolment	216
Start date	2008-07
Completion	2010-05

Conditions

• Invasive Candidiasis

Interventions

• Anidulafungin
• Fluconazole
• Voriconazole

Primary outcomes

• Percentage of Participants With Global Treatment Response Success at End of Treatment — End of Treatment (Day 14 to Day 56)
  Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

Countries

Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, Turkey (Türkiye), Ukraine, United Kingdom