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

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

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).

Study Overview

• Status: Completed
• Conditions: Mycoses; Candidemia; Fungal Infection; Invasive Candidiases
• Intervention / Treatment: Drug: Rezafungin for Injection; Drug: Fluconazole; Drug: oral placebo; Drug: Caspofungin; Drug: intravenous placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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.
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Rezafungin for Injection; 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.	Drug: Rezafungin for Injection; Intravenous antifungal therapy; Drug: oral placebo; Microcrystalline cellulose; Other Names: encapsulated cellulose
Active Comparator: Group 2: Caspofungin; 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.	Drug: Fluconazole; Oral antifungal therapy; Other Names: generic fluconazole; Drug: Caspofungin; Intravenous antifungal therapy; Other Names: Cancidas; Drug: intravenous placebo; Normal saline; Other Names: placebo infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 30 (-2 days)
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.	Day 14 (±1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 14 (±1 day)
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.	Day 30 (-2 days)
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.	Day 5, Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose) and Follow-up (Days 52-59)
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.	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)
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.	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)
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.	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)
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.	Day 1 through Follow-up Visit (Days 52-59)
Evaluate Pharmacokinetics (Cmax)	Evaluate the maximum plasma concentration (Cmax) of rezafungin for injection.	Day 1, 10 minutes before the end of infusion
Evaluate Pharmacokinetics (Cmin)	Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.	Day 8, pre-dose, within 30 minutes prior to the start of infusion
Evaluate Pharmacokinetics (Cmin)	Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.	Day 15, pre-dose, within 30 minutes prior to the start of infusion
Evaluate Pharmacokinetics (Cmin)	Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.	Day 22, pre-dose, within 30 minutes prior to the start of infusion

Collaborators and Investigators

• Sponsor: Cidara Therapeutics Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2018
• Primary Completion (Actual): October 7, 2021
• Study Completion (Actual): October 7, 2021

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pathologic Processes; Invasive Fungal Infections; Fluconazole; Caspofungin; Candidiasis; Sepsis; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Physiological Effects of Drugs; Systemic Inflammatory Response Syndrome; Candidemia; Antifungal Agents; Fungemia; Molecular Mechanisms of Pharmacological Action; Mycoses; Candidiasis, Invasive; Echinocandins; 14-alpha Demethylase Inhibitors; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Anti-infective Agents
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Sepsis; Invasive Fungal Infections; Fungemia; Candidiasis; Candidemia; Candidiasis, Invasive; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Caspofungin; Fluconazole; Rezafungin
• Other Study ID Numbers: CD101.IV.3.05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No