CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension

A Phase 2, Multicenter, Randomized, Double-blind Study of the Safety, Tolerability, and Efficacy of Intravenous CD101 vs Intravenous Caspofungin Followed by Oral Fluconazole Step-down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

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).

Inclusion Criteria:

• mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken less than or equal to 96 hours before randomization (defined as: at least 1 blood culture positive for Candida or positive test for Candida from a sponsor approved rapid diagnostic test or positive gram stain for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site)
• willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required. Patients receiving only medications and measures for comfort and not cure should not be enrolled.
• female subjects of child bearing potential <2 years post menopausal must agree to one barrier method and one highly effective method of birth control or sexual abstinence.
• male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm from first dose of CD101 (Day 1) until 90 days following last administration of study drug.
• willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on their behalf.
• presence of one or more systemic signs attributable to candidemia and/or invasive candidiasis

Exclusion Criteria:

• Any of the following forms of IC:

  1. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
  2. Osteomyelitis
  3. Endocarditis or myocarditis
  4. Meningitis, endophthalmitis, or any central nervous system infection

• neutropenia

• alanine aminotransferase or aspartate aminotransferase levels >10 fold the upper limit of normal

• severe hepatic impairment in subjects with a history of chronic cirrhosis

• greater than 48 hours systemic antifungal treatment at approved doses to treat candidemia

• pregnant females

• lactating females who are nursing

• known hypersensitivity to CD101, caspofungin, any echinocandin, or to any of their excipients

• previous participation in this or any previous CD101 study

• recent use of an investigational medicinal product within 28 days of first dose of study drug or presence of an investigational device at the time of screening

• Principal Investigator considers the subject should not participate

• presence of indwelling vascular catheter or device that cannot be removed and is likely to be the source of candidemia