A Study to evaluate the Safety, Tolerability, and Efficacy of CD101 Injection vs Intravenous Caspofungin Followed By Oral Fluconazole Step-down in the Treatment of Subjects with Candidemia

Phase 1

• Conditions: Candidemia; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 19.0Level: LLTClassification code 10060573Term: CandidemiaSystem Organ Class: 100000004862

• Registration Number: EUCTR2015-005599-51-ES
• Lead Sponsor: Cidara Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-09
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Subjects must meet ALL of the following inclusion criteria:
1. Males or females >=18 years.
2. Established mycological diagnosis of candidemia from a blood sample taken =<96 hours before randomization defined as:
a. >=1 blood culture positive for yeast or Candida
OR
b. Positive test for Candida from a Sponsor-approved rapid IVD
3. Life expectancy >72 hours
4. Female subjects of child-bearing potential <2 years post-menopausal must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence while participating in this study. Male subjects must agree to and comply with using one barrier method of birth control (e.g., male condom with spermicide) or sexual abstinence.
5. Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally authorized representative must provide informed consent on their behalf.
6. Presence of one or more systemic signs or symptoms attributable to candidemia (eg, fever, hypothermia, hypotension).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Subjects must NOT meet any of the following exclusion criteria:
1. Documented or suspected invasive candidiasis at any site including intra-abdominal infection, endocarditis, osteomyelitis, and meningitis
2. Neutropenia (absolute neutrophil count =<500/mcL) at screening or anticipated neutropenia during the study
3. Alanine aminotransferase or aspartate aminotransferase levels >10-fold the upper limit of normal
4. Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score >9)
5. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for >48 hours (for example, >2 doses of a once daily antifungal agent or >4 doses of a twice daily antifungal agent) in the last 96 hours before randomization
a. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible
6. Pregnant females
7. Lactating females who are nursing
8. Known hypersensitivity to CD101 Injection, caspofungin, any echinocandin, or to any of their excipients
9. Previous participation in this or any previous CD101 study.
10. Recent use of an investigational medicinal product within 28 days of the first dose of study drug or presence of an investigational device at the time of screening
11. The Principal Investigator considers that the subject should not participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified