Clinical Trials List
Protocol NumberCD101.IV.3.05
NCT Number(ClinicalTrials.gov Identfier)NCT03667690
2020-06-12 - 2022-09-01
Phase III
Not yet recruiting4
Terminated1
ICD-9112.9
Candidiasis of unspecified site
A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
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Sponsor
Cidara Therapeutics Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Kuo-Chin Kao Division of Thoracic Medicine
- 謝顯森 Division of Infectious Disease
- 胡漢忠 Division of Thoracic Medicine
- Junfu Ye Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Co-Principal Investigator
- Fu-Der Wang Division of Infectious Disease
- Ling Ju Huang Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Yee-Chun Chen Division of General Internal Medicine
- 陳抱宇 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Po-Liang Lu Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
- Shang-Yi Lin Division of Infectious Disease
- Chun-Yu Lin Division of Infectious Disease
- 羅世豪 Division of Infectious Disease
- 張雅婷 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 周家卉 Division of Infectious Disease
- Yu-Chao Lin Division of Infectious Disease
- 蔡元耀 Division of Infectious Disease
- 施文心 Division of Infectious Disease
- Jen-Hsien Wang Division of Infectious Disease
- Ming-Yu Lien Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Candidemia and/or Invasive Candidiasis
Objectives
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).
Test Drug
Rezafungin
Active Ingredient
Rezafungin acetate
Dosage Form
lyophilized powder for solution for infusion
Dosage
200 mg
Endpoints
Primary Outcome Measures :
All cause mortality (US FDA only) [ Time Frame: Day 30 (-2 days) ]
The number of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
All cause mortality (US FDA only) [ Time Frame: Day 30 (-2 days) ]
The percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
Global Cure (EU only) [ Time Frame: Day 14 (±1 day) ]
The number of subjects in each treatment group who have a global response of cure (clinical cure as assessed by the Investigator, radiological cure [for qualifying invasive candidiasis subjects at baseline], and mycological eradication, as confirmed by the DRC), failure and indeterminate in the modified Intent to Treat (mITT2) population.
Global Cure (EU only) [ Time Frame: Day 14 (±1 day) ]
The percentage of subjects in each treatment group who have a global response of cure (clinical cure as assessed by the Investigator, radiological cure [for qualifying invasive candidiasis subjects], and mycological eradication, as confirmed by the DRC), failure and indeterminate in the modified Intent to Treat (mITT) population.
All cause mortality (US FDA only) [ Time Frame: Day 30 (-2 days) ]
The number of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
All cause mortality (US FDA only) [ Time Frame: Day 30 (-2 days) ]
The percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
Global Cure (EU only) [ Time Frame: Day 14 (±1 day) ]
The number of subjects in each treatment group who have a global response of cure (clinical cure as assessed by the Investigator, radiological cure [for qualifying invasive candidiasis subjects at baseline], and mycological eradication, as confirmed by the DRC), failure and indeterminate in the modified Intent to Treat (mITT2) population.
Global Cure (EU only) [ Time Frame: Day 14 (±1 day) ]
The percentage of subjects in each treatment group who have a global response of cure (clinical cure as assessed by the Investigator, radiological cure [for qualifying invasive candidiasis subjects], and mycological eradication, as confirmed by the DRC), failure and indeterminate in the modified Intent to Treat (mITT) population.
Inclution Criteria
Inclusion Criteria:
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 his/her behalf.
Males or females ≥18 years of age.
Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤4 days (96 hours) before randomization defined as
≥1 blood culture positive for yeast or Candida OR
Positive test for Candida from a Sponsor-approved rapid IVD OR
Positive gram stain (or other method of direct microscopy) for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site.
Presence of one or more systemic signs attributable to candidemia or invasive candidiasis appearing from ≤12 hours prior to the qualifying positive culture through time of randomization.
Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
Female subjects of childbearing potential (all female subjects between 18 years <2 years post-menopausal unless surgically sterile) 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, or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception, and also agree not to donate sperm while participating in the study and for 90 days thereafter (and at least 120 days from the last dose of study drug).
For Candidemia only subjects, drawing of a set of blood cultures within 12 hours prior to randomization in the study. The result of these blood cultures is not required for inclusion in the study.
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 his/her behalf.
Males or females ≥18 years of age.
Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤4 days (96 hours) before randomization defined as
≥1 blood culture positive for yeast or Candida OR
Positive test for Candida from a Sponsor-approved rapid IVD OR
Positive gram stain (or other method of direct microscopy) for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site.
Presence of one or more systemic signs attributable to candidemia or invasive candidiasis appearing from ≤12 hours prior to the qualifying positive culture through time of randomization.
Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
Female subjects of childbearing potential (all female subjects between 18 years <2 years post-menopausal unless surgically sterile) 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, or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception, and also agree not to donate sperm while participating in the study and for 90 days thereafter (and at least 120 days from the last dose of study drug).
For Candidemia only subjects, drawing of a set of blood cultures within 12 hours prior to randomization in the study. The result of these blood cultures is not required for inclusion in the study.
Exclusion Criteria
Exclusion Criteria:
Any of the following forms of invasive candidiasis at baseline:
Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
Osteomyelitis
Endocarditis or myocarditis
Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection
Chronic disseminated candidiasis
Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract
Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for >48 hours (e.g., >2 doses of a once daily antifungal agent or >4 doses of a twice daily antifungal agent) ≤4 days (96 hours) before randomization
a. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible
Alanine aminotransferase or aspartate aminotransferase levels >10-fold the upper limit of normal
Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score >9)
Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or invasive candidiasis
Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients
Meets National Cancer Institute Common Terminology Criteria for Adverse Events, version 5, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher
History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease)
Planned or ongoing therapy at Screening with a known neurotoxic medication
Previous participation in this or any previous rezafungin study
Current participation in another interventional treatment trial with an investigational agent
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.
Pregnant or lactating females
The Principal Investigator (PI) is of the opinion the subject should not participate in the study
Any of the following forms of invasive candidiasis at baseline:
Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
Osteomyelitis
Endocarditis or myocarditis
Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection
Chronic disseminated candidiasis
Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract
Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for >48 hours (e.g., >2 doses of a once daily antifungal agent or >4 doses of a twice daily antifungal agent) ≤4 days (96 hours) before randomization
a. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible
Alanine aminotransferase or aspartate aminotransferase levels >10-fold the upper limit of normal
Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score >9)
Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or invasive candidiasis
Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients
Meets National Cancer Institute Common Terminology Criteria for Adverse Events, version 5, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher
History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease)
Planned or ongoing therapy at Screening with a known neurotoxic medication
Previous participation in this or any previous rezafungin study
Current participation in another interventional treatment trial with an investigational agent
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.
Pregnant or lactating females
The Principal Investigator (PI) is of the opinion the subject should not participate in the study
The Estimated Number of Participants
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Taiwan
15 participants
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Global
218 participants
