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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Rezafungin for Injection | Experimental | 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. |
|
| Group 2: Caspofungin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezafungin for Injection | Drug | Intravenous antifungal therapy |
| |
| 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) |
| 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. |
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Inclusion Criteria:
Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on his/her behalf.
Males or females ≥18 years of age.
Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤4 days (96 hours) before randomization defined as
Presence of one or more systemic signs attributable to candidemia or invasive candidiasis appearing from ≤12 hours prior to the qualifying positive culture through time of randomization.
Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
Female subjects of childbearing potential (all female subjects between 18 years <2 years post-menopausal unless surgically sterile) must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control, or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception, and also agree not to donate sperm while participating in the study and for 90 days thereafter (and at least 120 days from the last dose of study drug).
For Candidemia only subjects, drawing of a set of blood cultures within 12 hours prior to randomization in the study. The result of these blood cultures is not required for inclusion in the study.
Exclusion Criteria:
Any of the following forms of invasive candidiasis at baseline:
Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for >48 hours (e.g., >2 doses of a once daily antifungal agent or >4 doses of a twice daily antifungal agent) ≤4 days (96 hours) before randomization
a. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible
Alanine aminotransferase or aspartate aminotransferase levels >10-fold the upper limit of normal
Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score >9)
Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or invasive candidiasis
Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients
Meets National Cancer Institute Common Terminology Criteria for Adverse Events, version 5, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher
History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease)
Planned or ongoing therapy at Screening with a known neurotoxic medication
Previous participation in this or any previous rezafungin study
Current participation in another interventional treatment trial with an investigational agent
Recent use of an investigational medicinal product within 28 days of the first dose of study drug or presence of an investigational device at the time of screening.
Pregnant or lactating females
The Principal Investigator (PI) is of the opinion the subject should not participate in the study
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| Name | Affiliation | Role |
|---|---|---|
| Taylor Sandison, MD, MPH | Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| UC Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41940006 | Derived | 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. | |
| 41194465 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2020 | Sep 26, 2022 |
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| Caspofungin |
| Drug |
Intravenous antifungal therapy |
|
|
| Fluconazole | Drug | Oral antifungal therapy |
|
|
| intravenous placebo | Drug | Normal saline |
|
|
| oral placebo | Drug | Microcrystalline cellulose |
|
|
| 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 |
| Sacramento |
| California |
| 95817 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Hospital-Rochester | Rochester | Minnesota | 55902 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Washington University St. Louis | St Louis | Missouri | 63110 | United States |
| Mecury Street Medical | Butte | Montana | 59701 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| ID Clinical Research, Ltd. | Toledo | Ohio | 43608 | United States |
| University of Pittsburgh Falk Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Reading Hospital and Medical Center | West Reading | Pennsylvania | 19611 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Baylor Scott and White Medical Center | Temple | Texas | 76508 | United States |
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
| Alexander Fleming Specialized Medical Institute | Buenos Aires | Argentina |
| Cordoba Private Hospital | Córdoba | 5016 | Argentina |
| Allende Sanatorium | Córdoba | Argentina |
| Mayo Private Sanatorium | Córdoba | Argentina |
| Italian Hospital of Mendoza | Mendoza | Argentina |
| Westmead Public Hospital | Northmead | New South Wales | 2152 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Alfred Health | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital (RMH) | Parkville | Victoria | 3052 | Australia |
| Brugmann University Hospital Center | Brussels | 1020 | Belgium |
| Erasme Hospital | Brussels | 1070 | Belgium |
| University Hospital Brussels | Brussels | 1090 | Belgium |
| Saint Luc University Hospital | Brussels | 1200 | Belgium |
| University Hospitals Leuven, Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Multiprofile Hospital for Active Treatment Puls | Blagoevgrad | 2700 | Bulgaria |
| University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Clinic of Purulent-Septic Surgery | Sofia | 1606 | Bulgaria |
| University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD | Sofia | 1606 | Bulgaria |
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China |
| The Second People's Hospital of Hefei | Hefei | Anhui | 230011 | China |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
| Chongqing People's Hospital | Chongqing | Chongqing Municipality | 400013 | China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | 510000 | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| Qingyuan People's Hospital | Qingyuan | Guangdong | 511500 | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430071 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 210000 | China |
| Zibo Central Hospital | Zibo | Shandong | 255036 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610065 | China |
| Huashan Hospital Affiliated Fudan University | Shanghai | 200040 | China |
| Shanghai Pulmonary Hospital | Shanghai | 200433 | China |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | 300020 | China |
| General Hospital of Tianjin Medical University | Tianjin | 300052 | China |
| CEQUIN Foundation Cardiomet | Armenia | 630002 | Colombia |
| De La Costa Clinic Ltd. | Barranquilla | 080020 | Colombia |
| University IPS - Leon XIII Clinic | Medellín | 050012 | Colombia |
| Amiens Picardie University Hospital - South | Amiens | 80480 | France |
| Centre Hospitalier Victor Dupouy - Argenteuil | Argenteuil | 95107 | France |
| Roger Salengro Hospital | Lille | 59037 | France |
| Marseille University Hospital Center - North Hospital | Marseille | 13015 | France |
| Hotel Dieu Hospital Nantes University Hospital Center | Nantes | 44093 | France |
| Saint-Louis Hospital | Paris | 75475 | France |
| Paris University Hospitals Center - Cochin Hospital | Paris | 95107 | France |
| University Hospital Center of Poitiers | Poitiers | 86021 | France |
| Civil Hospital of Strasbourg | Strasbourg | 67091 | France |
| Tours University Hospital Center, Bretonneau Hospital | Tours | 37000 | France |
| University Hospital Köln | Cologne | 50937 | Germany |
| University Hospital Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Johannes Gutenberg University Medical Center | Mainz | 55131 | Germany |
| General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit | Athens | 10676 | Greece |
| General Hospital of Athens "Evangelismos" | Athens | 10676 | Greece |
| General Hospital of Athens "Laikon", Infectious Diseases Unit | Athens | 11527 | Greece |
| General Hospital of Athens "Laikon" | Athens | 11527 | Greece |
| General Hospital of Thessaloniki Ippokratio | Thessaloniki | 54642 | Greece |
| Bnai Zion Medical Center | Haifa | 3339419 | Israel |
| Lady Davis Carmel Medical Center | Haifa | 3436212 | Israel |
| Rambam Health Care Campus | Haifa | 35254 | Israel |
| Edith Wolfson Medical Center | Holon | 5822012 | Israel |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| The Baruch Padeh Medical Center | Nazareth | 16100 | Israel |
| Ziv Medical Center | Safed | 1311001 | Israel |
| The Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Chaim Sheba Medical Center | Tel Litwinsky | 5262000 | Israel |
| Polyclinic S. Orsola-Malpighi, Dept. of Organ Impairment and Transplants | Bologna | 40138 | Italy |
| ASST Large Metropolitan Hospital Niguarda, Infectious Diseases Department | Milan | 20161 | Italy |
| University Polyclinic Hospital of Modena | Modena | 41124 | Italy |
| University Hospital of Modena | Modena | 71-41124 | Italy |
| University of Milano-Bicocca - San Gerardo Hospital | Monza | 20900 | Italy |
| University Polyclinic Hospital "Paolo Giaccone" Palermo, Infectious Disease Department, ICU | Palermo | 90127 | Italy |
| University Polyclinic Foundation Agostino Gemelli - IRCCS | Rome | 00168 | Italy |
| Integrated University Health Authority of Trieste | Trieste | 34125 | Italy |
| Integrated University Hospital "Santa Maria della Misericordia" of Udine | Udine | 22100 | Italy |
| National University Hospital | Singapore | 119074 | Singapore |
| Tan Tock Seng Hospital | Singapore | 119074 | Singapore |
| Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Chung-Ang University Hospital | Seoul | 06793 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| University Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| University Hospital Cruces | Barakaldo | 48903 | Spain |
| Hospital del Mar, Department of Infectious Diseases | Barcelona | 08003 | Spain |
| University Hospital Vall d'Hebron (HUVH) | Barcelona | 08035 | Spain |
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
| Parc Tauli Health Corporation | Barcelona | 08208 | Spain |
| General University Hospital Gregorio Maranon | Madrid | 28007 | Spain |
| University Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| University Hospital Clinical San Carlos | Madrid | 28040 | Spain |
| La Paz University Hospital | Madrid | 28046 | Spain |
| University Hospital Puerta de Hierro Majadahonda | Majadahonda | 28220 | Spain |
| University Hospital Virgen Macarena | Seville | 41009 | Spain |
| University and Polytechnic Hospital La Fe | Valencia | 46026 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan City | 333 | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | 50200 | Thailand |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Thammasat University Hospital | Pathum Thani | 12120 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Hacettepe University School of Medicine | Ankara | 06100 | Turkey (Türkiye) |
| Ankara University School of Medicine | Ankara | 06230 | Turkey (Türkiye) |
| Istanbul University School of Medicine | Istanbul | 34093 | Turkey (Türkiye) |
| Marmara University Pendik Training and Research Hospital | Istanbul | 34899 | Turkey (Türkiye) |
| Medipol Mega University Hospital | Istanbul | Turkey (Türkiye) |
| 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. |
| 39529079 | Derived | 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. |
| 39468640 | Derived | 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. |
| 39259571 | Derived | 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. |
| 38985561 | Derived | 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. |
| 38502709 | Derived | 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. |
| 38008099 | Derived | 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. |
| 36442484 | Derived | 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. |
| 33438477 | Derived | 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. |
| FG001 | 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 |
|
| Completed Study Drug Regimen Through Study Day 14 | Discontinuations of study drug prior to Day 14 occurred in 34 and 28 subjects in the rezafungin for injection and caspofungin treatment groups, respectively. The primary reasons for study drug discontinuation prior to Day 14 were death and adverse events. Other reasons for study drug discontinuation prior to Day 14 were singular in nature and did not have a clear pattern for reason or relationship to treatment assignment. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) population analyzed consisted of all subjects randomized to treatment. Subjects were analyzed based on the treatment group to which they were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Data was not captured for all subjects, as some subjects did not have weight determined at Screening. | Mean | Standard Deviation | kilograms |
| ||||||||||||||
| Weight | Data was not captured for all subjects, as some subjects did not have weight determined at Screening. | Median | Full Range | kilograms |
| ||||||||||||||
| Height | Data was not captured for all subjects, as some subjects did not have height determined at Screening. | Mean | Standard Deviation | centimeters |
| ||||||||||||||
| Height | Data was not captured for all subjects, as some subjects did not have height determined at Screening. | Median | Full Range | centimeters |
| ||||||||||||||
| Body Mass Index (BMI) | Data was not captured for all subjects, as some subjects did not have BMI calculated at Screening. | Mean | Standard Deviation | kilograms/meter^2 |
| ||||||||||||||
| Body Mass Index (BMI) | Data was not captured for all subjects, as some subjects did not have BMI calculated at Screening. | Median | Full Range | kilograms/meter^2 |
| ||||||||||||||
| Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score Category | The APACHE II score is a validated predictor of mortality in critically ill patients. It can be used in clinical trials at baseline to estimate the overall severity of illness in a patient population. Knaus WA, et al. APACHE II: a severity of disease classification system. Crit Care Med. 1985 13(10):818-29. APACHE II score = acute physiology score + age points + chronic health points. Minimum score = 0; maximum score = 71. Subjects were stratified by estimated mortality (as a percentage) based on APACHE II scores: 0-9 (4-8%), 10-19 (15-24%), ≥20 (≥40%). | Count of Participants | Participants |
| |||||||||||||||
| Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score | The APACHE II score is a validated predictor of mortality in critically ill patients. Knaus WA, et al. APACHE II: a severity of disease classification system. Crit Care Med. 1985 13(10):818-29.APACHE II score = acute physiology score + age points + chronic health points. Minimum score = 0; maximum score = 71. A mean APACHE II score of 0-19 indicates an estimated mortality (as a percentage) of 4-24%, whereas a score ≥20 reflects a more severely ill patient population with estimated mortality ≥40%. | Data was not captured for all subjects, as some subjects did not have the modified APACHE II calculation performed. | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score | The APACHE II score is a validated predictor of mortality in critically ill patients. Knaus WA, et al. APACHE II: a severity of disease classification system. Crit Care Med. 1985 13(10):818-29. APACHE II score = acute physiology score + age points + chronic health points. Minimum score = 0; maximum score = 71. A median APACHE II score of 0-19 indicates an estimated mortality (as a percentage) of 4-24%, whereas a score ≥20 reflects a more severely ill patient population with estimated mortality ≥40%. | Data was not captured for all subjects, as some subjects did not have the modified APACHE II calculation performed. | Median | Full Range | units on a scale |
| |||||||||||||
| Absolute Neutrophil Count (ANC) (per microliter) at Baseline | Count of Participants | Participants |
| ||||||||||||||||
| Modified APACHE II Score/ANC | Count of Participants | Participants |
| ||||||||||||||||
| Randomization Strata | Count of Participants | Participants |
| ||||||||||||||||
| Estimated Creatinine Clearance | Data was not captured for all subjects, as some subjects did not have the creatinine clearance calculation performed. | Mean | Standard Deviation | milliliters (mL)/minute |
| ||||||||||||||
| Estimated Creatinine Clearance | Data was not captured for all subjects, as some subjects did not have the creatinine clearance calculation performed. | Median | Full Range | milliliters (mL)/minute |
| ||||||||||||||
| Child-Pugh Score Category | The Child-Pugh score employs 5 clinical measures of liver disease, each being scored 1 to 3 (least to most severe). The sum of the 5 measures is the total Child-Pugh point score. A total score <7 indicates mild hepatic impairment; a score of 7-9 indicates moderate hepatic impairment; and a score >9 indicates severe hepatic impairment. Calculation of the Child-Pugh score was only required for subjects with a history of chronic cirrhosis. Subjects with no medical history of liver disease were included in the 'No History of Liver Disease/Not Calculated' category regardless of Child-Pugh score. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Day 30 (-2 days) |
|
|
| |||||||||||||||||||||||||||||||
| Primary | 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. | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Day 14 (±1 day) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Day 14 (±1 day) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Day 30 (-2 days) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Day 5, Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose) and Follow-up (Days 52-59) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Population includes all subjects who received any amount of the study drug. Safety analyses were performed on the Safety Population. Subjects who received the wrong study drug for their entire course of study drug were analyzed in the treatment group based on the drug received. Subjects who received the wrong study drug for part of their course of study drug were analyzed in the treatment group based on majority of (i.e., most frequent) doses received. | Posted | Count of Participants | Participants | Day 1 through Follow-up Visit (Days 52-59) |
| |||||||||||||||||||||||||||||||||
| Secondary | Evaluate Pharmacokinetics (Cmax) | Evaluate the maximum plasma concentration (Cmax) of rezafungin for injection. | The Pharmacokinetic (PK) Population includes all subjects who received any amount of study drug and had at least one blood sample with measurable concentrations. Note: Although blood samples were collected from all subjects receiving study drug, only PK samples from subjects receiving rezafungin for injection were analyzed. | Posted | Mean | Standard Deviation | micrograms/milliliter | Day 1, 10 minutes before the end of infusion |
|
| |||||||||||||||||||||||||||||||
| Secondary | Evaluate Pharmacokinetics (Cmin) | Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection. | The Pharmacokinetic (PK) Population includes all subjects who received any amount of study drug and had at least one blood sample with measurable concentrations. Note: Although blood samples were collected from all subjects receiving study drug, only PK samples from subjects receiving rezafungin for injection were analyzed. | Posted | Mean | Standard Deviation | micrograms/milliliter | Day 8, pre-dose, within 30 minutes prior to the start of infusion |
|
| |||||||||||||||||||||||||||||||
| Secondary | Evaluate Pharmacokinetics (Cmin) | Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection. | The Pharmacokinetic (PK) Population includes all subjects who received any amount of study drug and had at least one blood sample with measurable concentrations. Note: Although blood samples were collected from all subjects receiving study drug, only PK samples from subjects receiving rezafungin for injection were analyzed. | Posted | Mean | Standard Deviation | micrograms/milliliter | Day 15, pre-dose, within 30 minutes prior to the start of infusion |
|
| |||||||||||||||||||||||||||||||
| Secondary | Evaluate Pharmacokinetics (Cmin) | Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection. | The Pharmacokinetic (PK) Population includes all subjects who received any amount of study drug and had at least one blood sample with measurable concentrations. Note: Although blood samples were collected from all subjects receiving study drug, only PK samples from subjects receiving rezafungin for injection were analyzed. | Posted | Mean | Standard Deviation | micrograms/milliliter | Day 22, pre-dose, within 30 minutes prior to the start of infusion |
|
|
Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing.
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 29 | 98 | 55 | 98 | 90 | 98 |
| EG001 | 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 | 25 | 98 | 52 | 98 | 66 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA Version 23.0 | Systematic Assessment | Incudes 1 serious adverse event described as Death NOS (not otherwise specified) |
|
| Septic shock | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Catheter bacteraemia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Acinetobacter sepsis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gastric cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pneumonia lipoid | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Shock | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Abdominal abscess | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Splenic haemorrhage | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Left ventricular dysfunction | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Colonic fistula | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Haemoperitoneum | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Proctitis | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Complication associated with device | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hernia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hepatic infarction | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Abdominal infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Cryptococcosis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Endocarditis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Enterococcal sepsis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Fusarium infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Pseudomonal sepsis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Septic pulmonary embolism | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Systemic candida | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Vascular device infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Drain site complication | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Alkalosis hypochloraemic | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hypertensive encephalopathy | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Red man syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taylor Sandison, M.D., MPH | Cidara Therapeutics, Inc. | 858-888-7868 | clinicaltrialinfo@cidara.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2021 | Sep 26, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D058387 | Candidemia |
| D009181 | Mycoses |
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D000072742 | Invasive Fungal Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007249 | Inflammation |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629634 | Rezafungin |
| D007267 | Injections |
| D000077336 | Caspofungin |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Belgium |
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| Bulgaria |
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| China |
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| Colombia |
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| France |
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| Greece |
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| Israel |
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| Italy |
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| Singapore |
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| South Korea |
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| Spain |
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| Taiwan |
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| Thailand |
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| United States |
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| Alive |
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| OG001 | 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 |
|
|
| OG001 | 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 |
|
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| OG001 | 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 |
|
|
| OG001 | 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 |
|
|
| OG001 | 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 |
|
|
| OG001 | 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 |
|
|
| OG001 | 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 |
|
|
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| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Failure |
|
| Indeterminate |
|
| Failure |
|
| Indeterminate |
|
| Failure |
|
| Indeterminate |
|
| Failure |
|
| Indeterminate |
|