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Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis (ReSTORE)

Primary Purpose

Candidemia, Mycoses, Fungal Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rezafungin for Injection
Caspofungin
Fluconazole
intravenous placebo
oral placebo
Sponsored by
Cidara Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidemia focused on measuring Mycoses, Candidiasis, Candidiasis, Invasive, Candidemia, Fungemia, Sepsis, Invasive Fungal Infections, Systemic Inflammatory Response Syndrome, Pathologic Processes, Fluconazole, Caspofungin, Echinocandins, Antifungal Agents, Anti-infective Agents, 14-alpha Demethylase Inhibitors, Cytochrome P-450 Enzyme Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Steroid Synthesis Inhibitors, Physiological Effects of Drugs, Cytochrome P-450 CYP2C9 Inhibitors, Cytochrome P-450 CYP2C19 Inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Males or females ≥18 years of age.

  3. 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.
  4. 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.
  5. Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
  6. 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).
  7. 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:

  1. Any of the following forms of invasive candidiasis at baseline:

    1. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
    2. Osteomyelitis
    3. Endocarditis or myocarditis
    4. Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection
    5. Chronic disseminated candidiasis
    6. Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract

  2. 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

  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. 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
  6. Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients
  7. 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
  8. 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)
  9. Planned or ongoing therapy at Screening with a known neurotoxic medication
  10. Previous participation in this or any previous rezafungin study
  11. Current participation in another interventional treatment trial with an investigational agent
  12. 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.
  13. Pregnant or lactating females
  14. The Principal Investigator (PI) is of the opinion the subject should not participate in the study

Sites / Locations

  • University of Alabama
  • UC Davis
  • Emory University Hospital
  • Augusta University
  • Johns Hopkins
  • Henry Ford Health System
  • University of Minnesota
  • Mayo Clinic Hospital-Rochester
  • University of Mississippi Medical Center
  • Washington University St. Louis
  • Mecury Street Medical
  • University of North Carolina
  • Duke University Medical Center
  • ID Clinical Research, Ltd.
  • University of Pittsburgh Falk Medical Center
  • Reading Hospital and Medical Center
  • The University of Texas Health Science Center at San Antonio
  • Baylor Scott and White Medical Center
  • Carilion Clinic
  • Alexander Fleming Specialized Medical Institute
  • Cordoba Private Hospital
  • Allende Sanatorium
  • Mayo Private Sanatorium
  • Italian Hospital of Mendoza
  • Westmead Public Hospital
  • Monash Health
  • Peter MacCallum Cancer Centre
  • Alfred Health
  • Royal Melbourne Hospital (RMH)
  • Brugmann University Hospital Center
  • Erasme Hospital
  • University Hospital Brussels
  • Saint Luc University Hospital
  • University Hospitals Leuven, Campus Gasthuisberg
  • Multiprofile Hospital for Active Treatment Puls
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Clinic of Purulent-Septic Surgery
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD
  • The First Affiliated Hospital of Bengbu Medical College
  • The Second People's Hospital of Hefei
  • The Second Hospital of Anhui Medical University
  • Chongqing People's Hospital
  • Guangzhou First People's Hospital
  • Guangdong Provincial People's Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • Qingyuan People's Hospital
  • Zhongnan Hospital of Wuhan University
  • The Second Xiangya Hospital of Central South University
  • Nanjing First Hospital
  • Zibo Central Hospital
  • West China Hospital, Sichuan University
  • Huashan Hospital Affiliated Fudan University
  • Shanghai Pulmonary Hospital
  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
  • General Hospital of Tianjin Medical University
  • CEQUIN Foundation Cardiomet
  • De La Costa Clinic Ltd.
  • University IPS - Leon XIII Clinic
  • Amiens Picardie University Hospital - South
  • Centre Hospitalier Victor Dupouy - Argenteuil
  • Roger Salengro Hospital
  • Marseille University Hospital Center - North Hospital
  • Hotel Dieu Hospital Nantes University Hospital Center
  • Saint-Louis Hospital
  • Paris University Hospitals Center - Cochin Hospital
  • University Hospital Center of Poitiers
  • Civil Hospital of Strasbourg
  • Tours University Hospital Center, Bretonneau Hospital
  • University Hospital Köln
  • University Hospital Freiburg
  • Johannes Gutenberg University Medical Center
  • General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
  • General Hospital of Athens "Evangelismos"
  • General Hospital of Athens "Laikon", Infectious Diseases Unit
  • General Hospital of Athens "Laikon"
  • General Hospital of Thessaloniki Ippokratio
  • Bnai Zion Medical Center
  • Lady Davis Carmel Medical Center
  • Rambam Health Care Campus
  • Edith Wolfson Medical Center
  • Hadassah Medical Center
  • The Baruch Padeh Medical Center
  • Ziv Medical Center
  • The Tel Aviv Sourasky Medical Center
  • Chaim Sheba Medical Center
  • Polyclinic S. Orsola-Malpighi, Dept. of Organ Impairment and Transplants
  • ASST Large Metropolitan Hospital Niguarda, Infectious Diseases Department
  • University Polyclinic Hospital of Modena
  • University Hospital of Modena
  • University of Milano-Bicocca - San Gerardo Hospital
  • University Polyclinic Hospital "Paolo Giaccone" Palermo, Infectious Disease Department, ICU
  • University Polyclinic Foundation Agostino Gemelli - IRCCS
  • Integrated University Health Authority of Trieste
  • Integrated University Hospital "Santa Maria della Misericordia" of Udine
  • Wonju Severance Christian Hospital
  • Dong-A University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Chung-Ang University Hospital
  • Ajou University Hospital
  • National University Hospital
  • Tan Tock Seng Hospital
  • University Hospital Germans Trias i Pujol
  • University Hospital Cruces
  • Hospital del Mar, Department of Infectious Diseases
  • University Hospital Vall d'Hebron (HUVH)
  • Hospital Clinic of Barcelona
  • Parc Tauli Health Corporation
  • General University Hospital Gregorio Maranon
  • University Hospital Ramon y Cajal
  • University Hospital Clinical San Carlos
  • La Paz University Hospital
  • University Hospital Puerta de Hierro Majadahonda
  • University Hospital Virgen Macarena
  • University and Polytechnic Hospital La Fe
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Linkou Chang Gung Memorial Hospital
  • King Chulalongkorn Memorial Hospital
  • Rajavithi Hospital
  • Ramathibodi Hospital
  • Siriraj Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Srinagarind Hospital
  • Thammasat University Hospital
  • Songklanagarind Hospital
  • Hacettepe University School of Medicine
  • Ankara University School of Medicine
  • Istanbul University School of Medicine
  • Marmara University Pendik Training and Research Hospital
  • Medipol Mega University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Rezafungin for Injection

Group 2: Caspofungin

Arm Description

Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day.

Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind.

Outcomes

Primary Outcome Measures

All-Cause Mortality (US FDA Only)
The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only)
The number and 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 at baseline], and mycological eradication, as confirmed by the Data Review Committee [DRC]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol.

Secondary Outcome Measures

Global Response as Assessed by Data Review Committee (US FDA Only)
The number and 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 at baseline], and mycological eradication, as confirmed by the Data Review Committee [DRC]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol.
All-Cause Mortality (EU EMA Only)
The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
Comparison of Global Response (as Assessed by the DRC) by Visit
The number and 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 at baseline], and mycological eradication, as confirmed by the Data Review Committee [DRC]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol.
Comparison of Mycological Eradication by Visit
The number and percentage of subjects in each treatment group who have a mycological response of eradication, failure, or indeterminate in the mITT population. A mycological response of eradication means clearance of objective evidence of infection and is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was eradication or failure. Definitions for the mycological responses of eradication, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 8 (Mycological Response) of the clinical protocol. Note: Eradication includes both documented and presumed eradication.
Comparison of Investigators' Assessment of Clinical Response by Visit
The number and percentage of subjects in each treatment group for whom the Investigator determined a clinical response of cure, failure, or indeterminate in the mITT population. A clinical response of cure, as assessed by the Investigator, is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the clinical responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 9 (Investigator's Assessment of Clinical Response) of the clinical protocol.
Comparison of Radiological Response by Investigator by Visit
The number and percentage of subjects with invasive candidiasis (documented by radiologic/imaging evidence at baseline) in each treatment group who have a radiological response (as assessed by the Investigator) of cure, failure, and indeterminate in the mITT population. A radiological response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the radiological responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 10 (Radiological Response) of the clinical protocol.
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and percentage of subjects in each treatment group that experienced at least one treatment-emergent adverse event (TEAE) based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and electrocardiogram (ECG) abnormalities. Notes: A subject with multiple adverse events (AEs) was counted only once. TEAE was defined as an AE that occurred during or after study drug administration and up through the Follow-up visit. The maximum severity and strongest relationship were counted for subjects with multiple events.
Evaluate Pharmacokinetics (Cmax)
Evaluate the maximum plasma concentration (Cmax) of rezafungin for injection.
Evaluate Pharmacokinetics (Cmin)
Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.
Evaluate Pharmacokinetics (Cmin)
Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.
Evaluate Pharmacokinetics (Cmin)
Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.

Full Information

First Posted
August 30, 2018
Last Updated
December 13, 2022
Sponsor
Cidara Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03667690
Brief Title
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
Acronym
ReSTORE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2018 (Actual)
Primary Completion Date
October 7, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cidara Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
A Phase 3, multicenter, prospective, randomized, double-blind, efficacy and safety study of Rezafungin for Injection versus an active comparator regimen of caspofungin followed by optional oral fluconazole step-down therapy in subjects with candidemia and/or invasive candidiasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidemia, Mycoses, Fungal Infection, Invasive Candidiases
Keywords
Mycoses, Candidiasis, Candidiasis, Invasive, Candidemia, Fungemia, Sepsis, Invasive Fungal Infections, Systemic Inflammatory Response Syndrome, Pathologic Processes, Fluconazole, Caspofungin, Echinocandins, Antifungal Agents, Anti-infective Agents, 14-alpha Demethylase Inhibitors, Cytochrome P-450 Enzyme Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Steroid Synthesis Inhibitors, Physiological Effects of Drugs, Cytochrome P-450 CYP2C9 Inhibitors, Cytochrome P-450 CYP2C19 Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Rezafungin for Injection
Arm Type
Experimental
Arm Description
Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day.
Arm Title
Group 2: Caspofungin
Arm Type
Active Comparator
Arm Description
Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind.
Intervention Type
Drug
Intervention Name(s)
Rezafungin for Injection
Intervention Description
Intravenous antifungal therapy
Intervention Type
Drug
Intervention Name(s)
Caspofungin
Other Intervention Name(s)
Cancidas
Intervention Description
Intravenous antifungal therapy
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
generic fluconazole
Intervention Description
Oral antifungal therapy
Intervention Type
Drug
Intervention Name(s)
intravenous placebo
Other Intervention Name(s)
placebo infusion
Intervention Description
Normal saline
Intervention Type
Drug
Intervention Name(s)
oral placebo
Other Intervention Name(s)
encapsulated cellulose
Intervention Description
Microcrystalline cellulose
Primary Outcome Measure Information:
Title
All-Cause Mortality (US FDA Only)
Description
The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
Time Frame
Day 30 (-2 days)
Title
Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only)
Description
The number and 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 at baseline], and mycological eradication, as confirmed by the Data Review Committee [DRC]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol.
Time Frame
Day 14 (±1 day)
Secondary Outcome Measure Information:
Title
Global Response as Assessed by Data Review Committee (US FDA Only)
Description
The number and 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 at baseline], and mycological eradication, as confirmed by the Data Review Committee [DRC]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol.
Time Frame
Day 14 (±1 day)
Title
All-Cause Mortality (EU EMA Only)
Description
The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
Time Frame
Day 30 (-2 days)
Title
Comparison of Global Response (as Assessed by the DRC) by Visit
Description
The number and 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 at baseline], and mycological eradication, as confirmed by the Data Review Committee [DRC]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol.
Time Frame
Day 5, Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose) and Follow-up (Days 52-59)
Title
Comparison of Mycological Eradication by Visit
Description
The number and percentage of subjects in each treatment group who have a mycological response of eradication, failure, or indeterminate in the mITT population. A mycological response of eradication means clearance of objective evidence of infection and is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was eradication or failure. Definitions for the mycological responses of eradication, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 8 (Mycological Response) of the clinical protocol. Note: Eradication includes both documented and presumed eradication.
Time Frame
Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59)
Title
Comparison of Investigators' Assessment of Clinical Response by Visit
Description
The number and percentage of subjects in each treatment group for whom the Investigator determined a clinical response of cure, failure, or indeterminate in the mITT population. A clinical response of cure, as assessed by the Investigator, is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the clinical responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 9 (Investigator's Assessment of Clinical Response) of the clinical protocol.
Time Frame
Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59)
Title
Comparison of Radiological Response by Investigator by Visit
Description
The number and percentage of subjects with invasive candidiasis (documented by radiologic/imaging evidence at baseline) in each treatment group who have a radiological response (as assessed by the Investigator) of cure, failure, and indeterminate in the mITT population. A radiological response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the radiological responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 10 (Radiological Response) of the clinical protocol.
Time Frame
Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59)
Title
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
The number and percentage of subjects in each treatment group that experienced at least one treatment-emergent adverse event (TEAE) based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and electrocardiogram (ECG) abnormalities. Notes: A subject with multiple adverse events (AEs) was counted only once. TEAE was defined as an AE that occurred during or after study drug administration and up through the Follow-up visit. The maximum severity and strongest relationship were counted for subjects with multiple events.
Time Frame
Day 1 through Follow-up Visit (Days 52-59)
Title
Evaluate Pharmacokinetics (Cmax)
Description
Evaluate the maximum plasma concentration (Cmax) of rezafungin for injection.
Time Frame
Day 1, 10 minutes before the end of infusion
Title
Evaluate Pharmacokinetics (Cmin)
Description
Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.
Time Frame
Day 8, pre-dose, within 30 minutes prior to the start of infusion
Title
Evaluate Pharmacokinetics (Cmin)
Description
Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.
Time Frame
Day 15, pre-dose, within 30 minutes prior to the start of infusion
Title
Evaluate Pharmacokinetics (Cmin)
Description
Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.
Time Frame
Day 22, pre-dose, within 30 minutes prior to the start of infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 in vitro diagnostic (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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taylor Sandison, MD, MPH
Organizational Affiliation
Cidara Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Hospital-Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mecury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
ID Clinical Research, Ltd.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
University of Pittsburgh Falk Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Reading Hospital and Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Baylor Scott and White Medical Center
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Alexander Fleming Specialized Medical Institute
City
Buenos Aires
Country
Argentina
Facility Name
Cordoba Private Hospital
City
Córdoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Allende Sanatorium
City
Córdoba
Country
Argentina
Facility Name
Mayo Private Sanatorium
City
Córdoba
Country
Argentina
Facility Name
Italian Hospital of Mendoza
City
Mendoza
Country
Argentina
Facility Name
Westmead Public Hospital
City
Northmead
State/Province
New South Wales
ZIP/Postal Code
2152
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital (RMH)
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Brugmann University Hospital Center
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
University Hospital Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Saint Luc University Hospital
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospitals Leuven, Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Multiprofile Hospital for Active Treatment Puls
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Clinic of Purulent-Septic Surgery
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
The Second People's Hospital of Hefei
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230011
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Chongqing People's Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400013
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Qingyuan People's Hospital
City
Qingyuan
State/Province
Guangdong
ZIP/Postal Code
511500
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Zibo Central Hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255036
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610065
Country
China
Facility Name
Huashan Hospital Affiliated Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
CEQUIN Foundation Cardiomet
City
Armenia
ZIP/Postal Code
630002
Country
Colombia
Facility Name
De La Costa Clinic Ltd.
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
University IPS - Leon XIII Clinic
City
Medellín
ZIP/Postal Code
050012
Country
Colombia
Facility Name
Amiens Picardie University Hospital - South
City
Amiens
ZIP/Postal Code
80480
Country
France
Facility Name
Centre Hospitalier Victor Dupouy - Argenteuil
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Roger Salengro Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Marseille University Hospital Center - North Hospital
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Hotel Dieu Hospital Nantes University Hospital Center
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Saint-Louis Hospital
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Paris University Hospitals Center - Cochin Hospital
City
Paris
ZIP/Postal Code
95107
Country
France
Facility Name
University Hospital Center of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Civil Hospital of Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Tours University Hospital Center, Bretonneau Hospital
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
University Hospital Köln
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
University Hospital Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Johannes Gutenberg University Medical Center
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
General Hospital of Athens "Evangelismos"
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
General Hospital of Athens "Laikon", Infectious Diseases Unit
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Athens "Laikon"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Thessaloniki Ippokratio
City
Thessaloníki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
35254
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
H̱olon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
The Baruch Padeh Medical Center
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
1311001
Country
Israel
Facility Name
The Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Polyclinic S. Orsola-Malpighi, Dept. of Organ Impairment and Transplants
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST Large Metropolitan Hospital Niguarda, Infectious Diseases Department
City
Milan
ZIP/Postal Code
20161
Country
Italy
Facility Name
University Polyclinic Hospital of Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
University Hospital of Modena
City
Modena
ZIP/Postal Code
71-41124
Country
Italy
Facility Name
University of Milano-Bicocca - San Gerardo Hospital
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
University Polyclinic Hospital "Paolo Giaccone" Palermo, Infectious Disease Department, ICU
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
University Polyclinic Foundation Agostino Gemelli - IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Integrated University Health Authority of Trieste
City
Trieste
ZIP/Postal Code
34125
Country
Italy
Facility Name
Integrated University Hospital "Santa Maria della Misericordia" of Udine
City
Udine
ZIP/Postal Code
22100
Country
Italy
Facility Name
Wonju Severance Christian Hospital
City
Wŏnju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06793
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
University Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
University Hospital Cruces
City
Baracaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital del Mar, Department of Infectious Diseases
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
University Hospital Vall d'Hebron (HUVH)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Parc Tauli Health Corporation
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
General University Hospital Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
University Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
University Hospital Clinical San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
La Paz University Hospital
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
University Hospital Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28220
Country
Spain
Facility Name
University Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
University and Polytechnic Hospital La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Thammasat University Hospital
City
Pathum Thani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Hacettepe University School of Medicine
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara University School of Medicine
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Istanbul University School of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Medipol Mega University Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
33438477
Citation
Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217.
Results Reference
derived

Learn more about this trial

Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis

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