Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03667690
Registration number
NCT03667690
Ethics application status
Date submitted
30/08/2018
Date registered
12/09/2018
Date last updated
6/01/2023
Titles & IDs
Public title
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
CD101.IV.3.05
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ReSTORE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Candidemia
0
0
Query!
Mycoses
0
0
Query!
Fungal Infection
0
0
Query!
Invasive Candidiases
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Rezafungin for Injection
Treatment: Drugs - Caspofungin
Treatment: Drugs - Fluconazole
Treatment: Drugs - intravenous placebo
Treatment: Drugs - oral placebo
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.
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.
Treatment: Drugs: Rezafungin for Injection
Intravenous antifungal therapy
Treatment: Drugs: Caspofungin
Intravenous antifungal therapy
Treatment: Drugs: Fluconazole
Oral antifungal therapy
Treatment: Drugs: intravenous placebo
Normal saline
Treatment: Drugs: oral placebo
Microcrystalline cellulose
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
All-Cause Mortality (US FDA Only)
Query!
Assessment method [1]
0
0
The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
Query!
Timepoint [1]
0
0
Day 30 (-2 days)
Query!
Primary outcome [2]
0
0
Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Day 14 (±1 day)
Query!
Secondary outcome [1]
0
0
Global Response as Assessed by Data Review Committee (US FDA Only)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Day 14 (±1 day)
Query!
Secondary outcome [2]
0
0
All-Cause Mortality (EU EMA Only)
Query!
Assessment method [2]
0
0
The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
Query!
Timepoint [2]
0
0
Day 30 (-2 days)
Query!
Secondary outcome [3]
0
0
Comparison of Global Response (as Assessed by the DRC) by Visit
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Day 5, Day 30 (-2 days), End of Treatment (EOT) (=2 days of last dose) and Follow-up (Days 52-59)
Query!
Secondary outcome [4]
0
0
Comparison of Mycological Eradication by Visit
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
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)
Query!
Secondary outcome [5]
0
0
Comparison of Investigators' Assessment of Clinical Response by Visit
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
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)
Query!
Secondary outcome [6]
0
0
Comparison of Radiological Response by Investigator by Visit
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
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)
Query!
Secondary outcome [7]
0
0
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability]
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Day 1 through Follow-up Visit (Days 52-59)
Query!
Secondary outcome [8]
0
0
Evaluate Pharmacokinetics (Cmax)
Query!
Assessment method [8]
0
0
Evaluate the maximum plasma concentration (Cmax) of rezafungin for injection.
Query!
Timepoint [8]
0
0
Day 1, 10 minutes before the end of infusion
Query!
Secondary outcome [9]
0
0
Evaluate Pharmacokinetics (Cmin)
Query!
Assessment method [9]
0
0
Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.
Query!
Timepoint [9]
0
0
Day 8, pre-dose, within 30 minutes prior to the start of infusion
Query!
Secondary outcome [10]
0
0
Evaluate Pharmacokinetics (Cmin)
Query!
Assessment method [10]
0
0
Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.
Query!
Timepoint [10]
0
0
Day 15, pre-dose, within 30 minutes prior to the start of infusion
Query!
Secondary outcome [11]
0
0
Evaluate Pharmacokinetics (Cmin)
Query!
Assessment method [11]
0
0
Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.
Query!
Timepoint [11]
0
0
Day 22, pre-dose, within 30 minutes prior to the start of infusion
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/10/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
7/10/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
199
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Westmead Public Hospital - Northmead
Query!
Recruitment hospital [2]
0
0
Monash Health - Clayton
Query!
Recruitment hospital [3]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [4]
0
0
Alfred Health - Melbourne
Query!
Recruitment hospital [5]
0
0
Royal Melbourne Hospital (RMH) - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2152 - Northmead
Query!
Recruitment postcode(s) [2]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [3]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [4]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [5]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Maryland
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Minnesota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Mississippi
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Montana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Virginia
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Buenos Aires
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Córdoba
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Mendoza
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Brussels
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Leuven
Query!
Country [20]
0
0
Bulgaria
Query!
State/province [20]
0
0
Blagoevgrad
Query!
Country [21]
0
0
Bulgaria
Query!
State/province [21]
0
0
Sofia
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Anhui
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Chongqing
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Guangdong
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Hubei
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Hunan
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Jiangsu
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Shandong
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Sichuan
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Shanghai
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Tianjin
Query!
Country [32]
0
0
Colombia
Query!
State/province [32]
0
0
Armenia
Query!
Country [33]
0
0
Colombia
Query!
State/province [33]
0
0
Barranquilla
Query!
Country [34]
0
0
Colombia
Query!
State/province [34]
0
0
Medellín
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Amiens
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Argenteuil
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Lille
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Marseille
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Nantes
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Paris
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Poitiers
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Strasbourg
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Tours
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Cologne
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Freiburg
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Mainz
Query!
Country [47]
0
0
Greece
Query!
State/province [47]
0
0
Athens
Query!
Country [48]
0
0
Greece
Query!
State/province [48]
0
0
Thessaloníki
Query!
Country [49]
0
0
Israel
Query!
State/province [49]
0
0
Haifa
Query!
Country [50]
0
0
Israel
Query!
State/province [50]
0
0
H_olon
Query!
Country [51]
0
0
Israel
Query!
State/province [51]
0
0
Jerusalem
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Nazareth
Query!
Country [53]
0
0
Israel
Query!
State/province [53]
0
0
Safed
Query!
Country [54]
0
0
Israel
Query!
State/province [54]
0
0
Tel Aviv
Query!
Country [55]
0
0
Israel
Query!
State/province [55]
0
0
Tel Hashomer
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Bologna
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Milan
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Modena
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Monza
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Palermo
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Rome
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Trieste
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Udine
Query!
Country [64]
0
0
Korea, Republic of
Query!
State/province [64]
0
0
Gangwon-do
Query!
Country [65]
0
0
Korea, Republic of
Query!
State/province [65]
0
0
Busan
Query!
Country [66]
0
0
Korea, Republic of
Query!
State/province [66]
0
0
Seoul
Query!
Country [67]
0
0
Korea, Republic of
Query!
State/province [67]
0
0
Suwon
Query!
Country [68]
0
0
Singapore
Query!
State/province [68]
0
0
Singapore
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Badalona
Query!
Country [70]
0
0
Spain
Query!
State/province [70]
0
0
Baracaldo
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Barcelona
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Madrid
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Majadahonda
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Sevilla
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Valencia
Query!
Country [76]
0
0
Taiwan
Query!
State/province [76]
0
0
Kaohsiung
Query!
Country [77]
0
0
Taiwan
Query!
State/province [77]
0
0
Taichung
Query!
Country [78]
0
0
Taiwan
Query!
State/province [78]
0
0
Taipei
Query!
Country [79]
0
0
Taiwan
Query!
State/province [79]
0
0
Taoyuan City
Query!
Country [80]
0
0
Thailand
Query!
State/province [80]
0
0
Bangkok
Query!
Country [81]
0
0
Thailand
Query!
State/province [81]
0
0
Chiang Mai
Query!
Country [82]
0
0
Thailand
Query!
State/province [82]
0
0
Khon Kaen
Query!
Country [83]
0
0
Thailand
Query!
State/province [83]
0
0
Pathum Thani
Query!
Country [84]
0
0
Thailand
Query!
State/province [84]
0
0
Songkhla
Query!
Country [85]
0
0
Turkey
Query!
State/province [85]
0
0
Ankara
Query!
Country [86]
0
0
Turkey
Query!
State/province [86]
0
0
Istanbul
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Cidara Therapeutics Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT03667690
Query!
Trial related presentations / 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Taylor Sandison, MD, MPH
Query!
Address
0
0
Cidara Therapeutics Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/90/NCT03667690/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/90/NCT03667690/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03667690
Download to PDF