Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
NCT ID: NCT03667690
Last Updated: 2023-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
199 participants
INTERVENTIONAL
2018-10-07
2021-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Rezafungin for Injection
Intravenous antifungal therapy
oral placebo
Microcrystalline cellulose
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.
Caspofungin
Intravenous antifungal therapy
Fluconazole
Oral antifungal therapy
intravenous placebo
Normal saline
Interventions
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Rezafungin for Injection
Intravenous antifungal therapy
Caspofungin
Intravenous antifungal therapy
Fluconazole
Oral antifungal therapy
intravenous placebo
Normal saline
oral placebo
Microcrystalline cellulose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. 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
18 Years
ALL
No
Sponsors
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Cidara Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Taylor Sandison, MD, MPH
Role: STUDY_DIRECTOR
Cidara Therapeutics Inc.
Locations
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University of Alabama
Birmingham, Alabama, United States
UC Davis
Sacramento, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Johns Hopkins
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Hospital-Rochester
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University St. Louis
St Louis, Missouri, United States
Mecury Street Medical
Butte, Montana, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
ID Clinical Research, Ltd.
Toledo, Ohio, United States
University of Pittsburgh Falk Medical Center
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Baylor Scott and White Medical Center
Temple, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Alexander Fleming Specialized Medical Institute
Buenos Aires, , Argentina
Cordoba Private Hospital
Córdoba, , Argentina
Allende Sanatorium
Córdoba, , Argentina
Mayo Private Sanatorium
Córdoba, , Argentina
Italian Hospital of Mendoza
Mendoza, , Argentina
Westmead Public Hospital
Northmead, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Royal Melbourne Hospital (RMH)
Parkville, Victoria, Australia
Brugmann University Hospital Center
Brussels, , Belgium
Erasme Hospital
Brussels, , Belgium
University Hospital Brussels
Brussels, , Belgium
Saint Luc University Hospital
Brussels, , Belgium
University Hospitals Leuven, Campus Gasthuisberg
Leuven, , Belgium
Multiprofile Hospital for Active Treatment Puls
Blagoevgrad, , Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Clinic of Purulent-Septic Surgery
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD
Sofia, , Bulgaria
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The Second People's Hospital of Hefei
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Chongqing People's Hospital
Chongqing, Chongqing Municipality, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Zibo Central Hospital
Zibo, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Huashan Hospital Affiliated Fudan University
Shanghai, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, , China
General Hospital of Tianjin Medical University
Tianjin, , China
CEQUIN Foundation Cardiomet
Armenia, , Colombia
De La Costa Clinic Ltd.
Barranquilla, , Colombia
University IPS - Leon XIII Clinic
Medellín, , Colombia
Amiens Picardie University Hospital - South
Amiens, , France
Centre Hospitalier Victor Dupouy - Argenteuil
Argenteuil, , France
Roger Salengro Hospital
Lille, , France
Marseille University Hospital Center - North Hospital
Marseille, , France
Hotel Dieu Hospital Nantes University Hospital Center
Nantes, , France
Saint-Louis Hospital
Paris, , France
Paris University Hospitals Center - Cochin Hospital
Paris, , France
University Hospital Center of Poitiers
Poitiers, , France
Civil Hospital of Strasbourg
Strasbourg, , France
Tours University Hospital Center, Bretonneau Hospital
Tours, , France
University Hospital Köln
Cologne, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
Johannes Gutenberg University Medical Center
Mainz, , Germany
General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
Athens, , Greece
General Hospital of Athens "Evangelismos"
Athens, , Greece
General Hospital of Athens "Laikon", Infectious Diseases Unit
Athens, , Greece
General Hospital of Athens "Laikon"
Athens, , Greece
General Hospital of Thessaloniki Ippokratio
Thessaloniki, , Greece
Bnai Zion Medical Center
Haifa, , Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Hadassah Medical Center
Jerusalem, , Israel
The Baruch Padeh Medical Center
Nazareth, , Israel
Ziv Medical Center
Safed, , Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Polyclinic S. Orsola-Malpighi, Dept. of Organ Impairment and Transplants
Bologna, , Italy
ASST Large Metropolitan Hospital Niguarda, Infectious Diseases Department
Milan, , Italy
University Polyclinic Hospital of Modena
Modena, , Italy
University Hospital of Modena
Modena, , Italy
University of Milano-Bicocca - San Gerardo Hospital
Monza, , Italy
University Polyclinic Hospital "Paolo Giaccone" Palermo, Infectious Disease Department, ICU
Palermo, , Italy
University Polyclinic Foundation Agostino Gemelli - IRCCS
Rome, , Italy
Integrated University Health Authority of Trieste
Trieste, , Italy
Integrated University Hospital "Santa Maria della Misericordia" of Udine
Udine, , Italy
National University Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Dong-A University Hospital
Busan, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
University Hospital Germans Trias i Pujol
Badalona, , Spain
University Hospital Cruces
Barakaldo, , Spain
Hospital del Mar, Department of Infectious Diseases
Barcelona, , Spain
University Hospital Vall d'Hebron (HUVH)
Barcelona, , Spain
Hospital Clinic of Barcelona
Barcelona, , Spain
Parc Tauli Health Corporation
Barcelona, , Spain
General University Hospital Gregorio Maranon
Madrid, , Spain
University Hospital Ramon y Cajal
Madrid, , Spain
University Hospital Clinical San Carlos
Madrid, , Spain
La Paz University Hospital
Madrid, , Spain
University Hospital Puerta de Hierro Majadahonda
Majadahonda, , Spain
University Hospital Virgen Macarena
Seville, , Spain
University and Polytechnic Hospital La Fe
Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Thammasat University Hospital
Pathum Thani, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Hacettepe University School of Medicine
Ankara, , Turkey (Türkiye)
Ankara University School of Medicine
Ankara, , Turkey (Türkiye)
Istanbul University School of Medicine
Istanbul, , Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Honore PM, Bassetti M, Cornely OA, Dupont H, Fortun J, Kollef MH, Pappas P, Pullman J, Vazquez J, Bielicka I, Dickerson S, Manamley N, Sandison T, Thompson GR. Length of hospital and intensive care unit stay in patients with invasive candidiasis and/or candidemia treated with rezafungin: a pooled analysis of two randomised controlled trials. Crit Care. 2024 Nov 11;28(1):361. doi: 10.1186/s13054-024-05152-2.
Honore PM, Girardis M, Kollef M, Cornely OA, Thompson GR 3rd, Bassetti M, Soriano A, Huang H, Vazquez J, Kullberg BJ, Pappas PG, Manamley N, Sandison T, Pullman J, Nseir S. Rezafungin versus caspofungin for patients with candidaemia or invasive candidiasis in the intensive care unit: pooled analyses of the ReSTORE and STRIVE randomised trials. Crit Care. 2024 Oct 28;28(1):348. doi: 10.1186/s13054-024-05117-5.
Clarke F, Grenfell A, Chao S, Richards H, Korman T, Rogers B. Use of echinocandin outpatient parenteral antimicrobial therapy for the treatment of infection caused by Candida spp.: utilization, outcomes and impact of a change to weekly dosing. J Antimicrob Chemother. 2024 Nov 4;79(11):2896-2900. doi: 10.1093/jac/dkae302.
Soriano A, Honore PM, Cornely OA, Chayakulkeeree M, Bassetti M, Haihui H, Dupont H, Kim YK, Kollef M, Kullberg BJ, Manamley N, Pappas P, Pullman J, Sandison T, Dignani C, Vazquez JA, Thompson GR 3rd. Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study. Clin Infect Dis. 2024 Sep 26;79(3):672-681. doi: 10.1093/cid/ciae363.
Smith HL, Bensman TJ, Mishra S, Li X, Dixon CA, Sheikh J, McMaster OG, Joshi A, Rubin DB, Goodwin A, Miller TJ, Danielsen ZY, Syed I, Shukla SJ, Iarikov D, Kim PW, Farley JJ. Regulatory Considerations in the Approval of Rezafungin (Rezzayo) for the Treatment of Candidemia and Invasive Candidiasis in Adults. J Infect Dis. 2024 Aug 16;230(2):505-513. doi: 10.1093/infdis/jiae146.
Thompson GR 3rd, Soriano A, Honore PM, Bassetti M, Cornely OA, Kollef M, Kullberg BJ, Pullman J, Hites M, Fortun J, Horcajada JP, Kotanidou A, Das AF, Sandison T, Aram JA, Vazquez JA, Pappas PG. Efficacy and safety of rezafungin and caspofungin in candidaemia and invasive candidiasis: pooled data from two prospective randomised controlled trials. Lancet Infect Dis. 2024 Mar;24(3):319-328. doi: 10.1016/S1473-3099(23)00551-0. Epub 2023 Nov 23.
Thompson GR 3rd, Soriano A, Cornely OA, Kullberg BJ, Kollef M, Vazquez J, Honore PM, Bassetti M, Pullman J, Chayakulkeeree M, Poromanski I, Dignani C, Das AF, Sandison T, Pappas PG; ReSTORE trial investigators. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial. Lancet. 2023 Jan 7;401(10370):49-59. doi: 10.1016/S0140-6736(22)02324-8. Epub 2022 Nov 25.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CD101.IV.3.05
Identifier Type: -
Identifier Source: org_study_id
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