AzTrials
AzTrials

CandidemiaPhase 3ReSTORENCT03667690

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

A Phase 3 study testing Rezafungin for Injection, Caspofungin and Fluconazole in people with Candidemia and Mycoses, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 132 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Candidemia, Mycoses, Fungal Infection
What is being tested?
Rezafungin for Injection, Caspofungin and Fluconazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
199 participants
Where
132 sitesin 18 countries
Study dates
7 Oct 2018to 7 Oct 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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
  • 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

Trial locations and contacts

132 sites in 18 countries.

132 sites in 18 countries

United States19 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Augusta University

    Augusta, Georgia, 30912

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • University of Alabama

    Birmingham, Alabama, 35294

  • Mecury Street Medical

    Butte, Montana, 59701

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • University of Pittsburgh Falk Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Carilion Clinic

    Roanoke, Virginia, 24014

  • Mayo Clinic Hospital-Rochester

    Rochester, Minnesota, 55902

  • UC Davis

    Sacramento, California, 95817

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Washington University St. Louis

    St Louis, Missouri, 63110

  • Baylor Scott and White Medical Center

    Temple, Texas, 76508

  • ID Clinical Research, Ltd.

    Toledo, Ohio, 43608

  • Reading Hospital and Medical Center

    West Reading, Pennsylvania, 19611

Other trials in United States

China17 sites

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610065

  • Chongqing People's Hospital

    Chongqing, Chongqing Municipality, 400013

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510000

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230011

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210000

  • Qingyuan People's Hospital

    Qingyuan, Guangdong, 511500

  • Huashan Hospital Affiliated Fudan University

    Shanghai, 200040

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, 300020

  • General Hospital of Tianjin Medical University

    Tianjin, 300052

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • Zibo Central Hospital

    Zibo, Shandong, 255036

Other trials in China

Spain13 sites

  • University Hospital Germans Trias i Pujol

    Badalona, 08916

  • University Hospital Cruces

    Barakaldo, 48903

  • Hospital del Mar, Department of Infectious Diseases

    Barcelona, 08003

  • University Hospital Vall d'Hebron (HUVH)

    Barcelona, 08035

  • Hospital Clinic of Barcelona

    Barcelona, 08036

  • Parc Tauli Health Corporation

    Barcelona, 08208

  • General University Hospital Gregorio Maranon

    Madrid, 28007

  • University Hospital Ramon y Cajal

    Madrid, 28034

  • University Hospital Clinical San Carlos

    Madrid, 28040

  • La Paz University Hospital

    Madrid, 28046

  • University Hospital Puerta de Hierro Majadahonda

    Majadahonda, 28220

  • University Hospital Virgen Macarena

    Seville, 41009

  • University and Polytechnic Hospital La Fe

    Valencia, 46026

Other trials in Spain

France10 sites

  • Amiens Picardie University Hospital - South

    Amiens, 80480

  • Centre Hospitalier Victor Dupouy - Argenteuil

    Argenteuil, 95107

  • Roger Salengro Hospital

    Lille, 59037

  • Marseille University Hospital Center - North Hospital

    Marseille, 13015

  • Hotel Dieu Hospital Nantes University Hospital Center

    Nantes, 44093

  • Saint-Louis Hospital

    Paris, 75475

  • Paris University Hospitals Center - Cochin Hospital

    Paris, 95107

  • University Hospital Center of Poitiers

    Poitiers, 86021

  • Civil Hospital of Strasbourg

    Strasbourg, 67091

  • Tours University Hospital Center, Bretonneau Hospital

    Tours, 37000

Other trials in France

Israel9 sites

  • Bnai Zion Medical Center

    Haifa, 3339419

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Rambam Health Care Campus

    Haifa, 35254

  • Edith Wolfson Medical Center

    Holon, 5822012

  • Hadassah Medical Center

    Jerusalem, 9112001

  • The Baruch Padeh Medical Center

    Nazareth, 16100

  • Ziv Medical Center

    Safed, 1311001

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Chaim Sheba Medical Center

    Tel HaShomer, 5262000

Other trials in Israel

Italy9 sites

  • Polyclinic S. Orsola-Malpighi, Dept. of Organ Impairment and Transplants

    Bologna, 40138

  • ASST Large Metropolitan Hospital Niguarda, Infectious Diseases Department

    Milan, 20161

  • University Polyclinic Hospital of Modena

    Modena, 41124

  • University Hospital of Modena

    Modena, 71-41124

  • University of Milano-Bicocca - San Gerardo Hospital

    Monza, 20900

  • University Polyclinic Hospital "Paolo Giaccone" Palermo, Infectious Disease Department, ICU

    Palermo, 90127

  • University Polyclinic Foundation Agostino Gemelli - IRCCS

    Rome, 00168

  • Integrated University Health Authority of Trieste

    Trieste, 34125

  • Integrated University Hospital "Santa Maria della Misericordia" of Udine

    Udine, 22100

Other trials in Italy

Thailand8 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Rajavithi Hospital

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Thammasat University Hospital

    Pathum Thani, 12120

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

South Korea6 sites

  • Dong-A University Hospital

    Busan, 49201

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • Chung-Ang University Hospital

    Seoul, 06793

  • Ajou University Hospital

    Suwon, 16499

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Argentina5 sites

  • Alexander Fleming Specialized Medical Institute

    Buenos Aires

  • Cordoba Private Hospital

    Córdoba, 5016

  • Allende Sanatorium

    Córdoba

  • Mayo Private Sanatorium

    Córdoba

  • Italian Hospital of Mendoza

    Mendoza

Other trials in Argentina

Australia5 sites

  • Monash Health

    Clayton, Victoria, 3168

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Alfred Health

    Melbourne, Victoria, 3004

  • Westmead Public Hospital

    Northmead, New South Wales, 2152

  • Royal Melbourne Hospital (RMH)

    Parkville, Victoria, 3052

Other trials in Australia

Belgium5 sites

  • Brugmann University Hospital Center

    Brussels, 1020

  • Erasme Hospital

    Brussels, 1070

  • University Hospital Brussels

    Brussels, 1090

  • Saint Luc University Hospital

    Brussels, 1200

  • University Hospitals Leuven, Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Greece5 sites

  • General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit

    Athens, 10676

  • General Hospital of Athens "Evangelismos"

    Athens, 10676

  • General Hospital of Athens "Laikon", Infectious Diseases Unit

    Athens, 11527

  • General Hospital of Athens "Laikon"

    Athens, 11527

  • General Hospital of Thessaloniki Ippokratio

    Thessaloniki, 54642

Other trials in Greece

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Hacettepe University School of Medicine

    Ankara, 06100

  • Ankara University School of Medicine

    Ankara, 06230

  • Istanbul University School of Medicine

    Istanbul, 34093

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34899

  • Medipol Mega University Hospital

    Istanbul

Other trials in Turkey (Türkiye)

Bulgaria3 sites

  • Multiprofile Hospital for Active Treatment Puls

    Blagoevgrad, 2700

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Clinic of Purulent-Septic Surgery

    Sofia, 1606

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD

    Sofia, 1606

Other trials in Bulgaria

Colombia3 sites

  • CEQUIN Foundation Cardiomet

    Armenia, 630002

  • De La Costa Clinic Ltd.

    Barranquilla, 080020

  • University IPS - Leon XIII Clinic

    Medellín, 050012

Other trials in Colombia

Germany3 sites

  • University Hospital Köln

    Cologne, 50937

  • University Hospital Freiburg

    Freiburg im Breisgau, 79106

  • Johannes Gutenberg University Medical Center

    Mainz, 55131

Other trials in Germany

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • Tan Tock Seng Hospital

    Singapore, 119074

Other trials in Singapore

About this study

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

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).

Read the 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.

Being tested
Rezafungin for Injection, Caspofungin, Fluconazole, intravenous placebo, oral placebo
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
Medical subject headings
Candidemia, Mycoses, Candidiasis, Invasive, Candidiasis, Fungemia, Sepsis, Invasive Fungal Infections, Systemic Inflammatory Response Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rezafungin for InjectionDrug

    Intravenous antifungal therapy

  • CaspofunginDrug

    Also called Cancidas

    Intravenous antifungal therapy

  • FluconazoleDrug

    Also called generic fluconazole

    Oral antifungal therapy

  • intravenous placeboDrug

    Also called placebo infusion

    Normal saline

  • oral placeboDrug

    Also called encapsulated cellulose

    Microcrystalline cellulose

Study groups in NCT03667690
Study groupRoleWhat they receive
Group 1: Rezafungin for InjectionExperimentalSubjects 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.
Receives: Drug: Rezafungin for Injection; Drug: oral placebo
Group 2: CaspofunginActive comparatorSubjects 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.
Receives: Drug: Caspofungin; Drug: Fluconazole; Drug: intravenous placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 30 (-2 days)

  2. 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.

    Measured: Day 14 (±1 day)

Secondary outcomes (11)

  1. 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.

    Measured: Day 14 (±1 day)

  2. 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.

    Measured: Day 30 (-2 days)

  3. 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.

    Measured: Day 5, Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose) and Follow-up (Days 52-59)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: Day 1 through Follow-up Visit (Days 52-59)

  8. Evaluate Pharmacokinetics (Cmax)

    Evaluate the maximum plasma concentration (Cmax) of rezafungin for injection.

    Measured: Day 1, 10 minutes before the end of infusion

  9. Evaluate Pharmacokinetics (Cmin)

    Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.

    Measured: Day 8, pre-dose, within 30 minutes prior to the start of infusion

  10. Evaluate Pharmacokinetics (Cmin)

    Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.

    Measured: Day 15, pre-dose, within 30 minutes prior to the start of infusion

  11. Evaluate Pharmacokinetics (Cmin)

    Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.

    Measured: Day 22, pre-dose, within 30 minutes prior to the start of infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start7 Oct 2018
  3. Primary completion7 Oct 2021
  4. Study completion7 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03667690
Sponsor's protocol ID
CD101.IV.3.05
Acronym
ReSTORE
Status last verified
Dec 2022
First submitted
30 Aug 2018
Last updated
6 Jan 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ostrosky-Zeichner L, Aram JA, Redell M, Thompson GR 3rd, Cornely OA, McKinnell JA, Spec A, Pappas PG. Exploring Early Antifungal Activity of Rezafungin as a Stepping-Stone for Shorter Treatment Duration for Candidemia: Pooled Analysis of 2 Randomized Trials. Open Forum Infect Dis. 2026 Mar 21;13(4):ofag143. doi: 10.1093/ofid/ofag143. eCollection 2026 Apr.

    PubMed 41940006

  • Huang H, Feng S, Yu Y, Zhang Y, Yuan Y, Cox L, Zhang Y. Efficacy and Safety of Rezafungin Versus Caspofungin for the Treatment of Candidemia and Invasive Candidiasis in a China Cohort of a Double-Blind, Randomised, Phase 3 Trial (ReSTORE China). Mycoses. 2025 Nov;68(11):e70122. doi: 10.1111/myc.70122.

    PubMed 41194465

  • 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.

    PubMed 39529079

  • 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.

    PubMed 39468640

  • 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.

    PubMed 39259571

  • 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.

    PubMed 38985561

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rezafungin for Injection, Caspofungin and Fluconazole in people with Candidemia and Mycoses, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 132 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, China, Spain, France, Israel and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-Cause Mortality (US FDA Only) (time frame: Day 30 (-2 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03667690, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.

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