The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).
This Bridging Extension is to determine if intravenous CD101 is safe \[Day 45- 52 for subjects with candidemia only, or Day 52- 59 for subjects with invasive candidiasis with or without candidemia\] and effective \[Day 14 (± 1 day)\] in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
207
Intravenous antifungal therapy
Intravenous antifungal therapy
oral antifungal therapy
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.
Time frame: From first dose of study drug through Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.
Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success]
Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline
Time frame: Day 14 (± 1 day)
Mycological Eradication and Resolution of Systemic Signs
Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population.
Time frame: Day 5, and Follow-up (FU Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.
Mycological Eradication
Evaluate mycological success (eradication) in the mITT population.
Time frame: Day 5, Day 14 (±1 day), and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia)
Clinical Cure
Evaluate clinical cure as assessed by the Investigator in the mITT population. Subjects must meet all of the following requirements: * Resolution of attributable systemic signs and symptoms of candidemia/IC that were present at baseline * No new systemic signs or symptoms attributable to candidemia/IC * No additional systemic antifungal therapy administered for candidemia/IC * The subject is alive
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normal saline
microcrystalline cellulose
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California - Davis
Davis, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Augusta University
Augusta, Georgia, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Harper University Hospital
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
...and 53 more locations
Time frame: Day 14 (±1 day) and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia).
Evaluate PK (Cmax)
Evaluate maximum plasma concentration (Cmax) (Part A only)
Time frame: Day 1, 10 minutes before end of infusion (EOI)
Evaluate PK (Cmin)
Evaluate minimum plasma concentration (Cmin) (Part A only)
Time frame: Day 8, predose
Evaluate PK (Cmin)
Evaluate minimum plasma concentration (Cmin) (Part A only)
Time frame: Day 15, predose