Phase 2
N=107
CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
Candidemia · Mycoses · Fungal Infection · Fungemia · Invasive Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT02734862 ↗Enrolled (actual)
107
Serious AEs
45.5%
Results posted
Dec 2020
Primary outcome: Primary: Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] — 71; 49; 55 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CD101 (Drug); Caspofungin (Drug); Fluconazole (Drug); intravenous placebo (Drug); oral placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] |
71; 49; 55 | — |
| PRIMARY Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] |
46; 35; 41 | — |
| SECONDARY Mycological Eradication and Resolution of Systemic Signs |
42; 34; 34; 36; 30; 36 | — |
| SECONDARY Mycological Eradication |
50; 35; 38; 50; 35; 42 | — |
| SECONDARY Clinical Cure |
53; 37; 43; 42; 32; 38 | — |
| SECONDARY Evaluate PK (Cmax) |
15.258; 14.743 | — |
| SECONDARY Evaluate PK (Cmin) |
3.068; 2.131 | — |
| SECONDARY Evaluate PK (Cmin) |
3.068; 2.131 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02734862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.