CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
Condition: Candidemia; Mycoses; Fungal Infection; Fungemia; Invasive Candidiasis
MeSH terms: Mycoses; Candidiasis; Candidemia; Candidiasis, Invasive; Fungemia
Intervention: CD101; Caspofungin; Fluconazole; intravenous placebo; oral placebo
Intervention description: Intravenous antifungal therapy; Intravenous antifungal therapy; oral antifungal therapy; normal saline; microcrystalline cellulose
Intervention MeSH terms: Fluconazole; Caspofungin; Rezafungin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mycoses

Summary:

      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).
    

Eligibility criteria:

        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