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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005599-51 | EudraCT Number |
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The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).
This Bridging Extension is to determine if intravenous CD101 is safe [Day 45- 52 for subjects with candidemia only, or Day 52- 59 for subjects with invasive candidiasis with or without candidemia] and effective [Day 14 (± 1 day)] in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. |
|
| Group 3 | Active Comparator | Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). 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. |
|
| Group 2 | Experimental | Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD101 | Drug | Intravenous antifungal therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities. | From first dose of study drug through Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia. |
| Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] | Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline | Day 14 (± 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Mycological Eradication and Resolution of Systemic Signs | Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population. | Day 5, and Follow-up (FU Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia. |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following forms of IC:
neutropenia
alanine aminotransferase or aspartate aminotransferase levels >10 fold the upper limit of normal
severe hepatic impairment in subjects with a history of chronic cirrhosis
greater than 48 hours systemic antifungal treatment at approved doses to treat candidemia
pregnant females
lactating females who are nursing
known hypersensitivity to CD101, caspofungin, any echinocandin, or to any of their excipients
previous participation in this or any previous CD101 study
recent use of an investigational medicinal product within 28 days of first dose of study drug or presence of an investigational device at the time of screening
Principal Investigator considers the subject should not participate
presence of indwelling vascular catheter or device that cannot be removed and is likely to be the source of candidemia
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| Name | Affiliation | Role |
|---|---|---|
| Taylor Sandison, MD MPH | Cidara Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California - 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. | |
| 39529079 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Part A |
|
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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 | Apr 20, 2018 | Sep 4, 2020 |
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| Caspofungin | Drug | Intravenous antifungal therapy |
|
|
| Fluconazole | Drug | oral antifungal therapy |
|
|
| intravenous placebo | Drug | normal saline |
|
|
| oral placebo | Drug | microcrystalline cellulose |
|
|
| Mycological Eradication | Evaluate mycological success (eradication) in the mITT population. | Day 5, Day 14 (±1 day), and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia) |
| Clinical Cure | Evaluate clinical cure as assessed by the Investigator in the mITT population. Subjects must meet all of the following requirements:
| Day 14 (±1 day) and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). |
| Evaluate PK (Cmax) | Evaluate maximum plasma concentration (Cmax) (Part A only) | Day 1, 10 minutes before end of infusion (EOI) |
| Evaluate PK (Cmin) | Evaluate minimum plasma concentration (Cmin) (Part A only) | Day 8, predose |
| Evaluate PK (Cmin) | Evaluate minimum plasma concentration (Cmin) (Part A only) | Day 15, predose |
| Davis |
| California |
| 95817 |
| United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Harper University Hospital | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mercury Street Medical | Butte | Montana | 59701 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Mercy Health - St. Vincent Medical Center - ID Clinical Research | Toledo | Ohio | 43608 | United States |
| Reading Hospital and Medical Center | West Reading | Pennsylvania | 19611 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Virginia Tech, Carillion School of Medicine | Roanoke | Virginia | 24016 | United States |
| Jules Bordet Institute | Brussels | 1000 | Belgium |
| CHU Brugman | Brussels | 1020 | Belgium |
| Erasme Hospital | Brussels | 1070 | Belgium |
| UCL Saint-LUC | Brussels | 1200 | Belgium |
| UZ Gent Algemene Inwendige Zietken | Ghent | 9000 | Belgium |
| University Hospital Brussels | Jette | 1090 | Belgium |
| University Hospital Leuven | Leuven | 3000 | Belgium |
| CHU Sart-Tillman | Liège | 4000 | Belgium |
| University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology | Sofia | 1431 | Bulgaria |
| University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Burns and Plastic Surgery Clinic, Department of Anesthesiology and Intensive Care | Sofia | 1606 | Bulgaria |
| Juravinski Hospital and Cancer Centre/Hamilton Health Sciences | Hamilton | Ontario | L8V 1C3 | Canada |
| Toronto General Hospital-University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
| CIUSSS de L'Est-de-l'Île-De-Montréal, Installation Hôpital | Montreal | Quebec | H1T 2M4 | Canada |
| McGill University Health Centre-Research Institute | Montreal | Quebec | H4A 3J1 | Canada |
| University General Hospital "Attikon", 2nd Department of Critical Care | Athens | Chaidari | 12 462 | Greece |
| General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit | Athens | 10676 | Greece |
| Laiko General Hospital of Athens | Athens | 115 27 | Greece |
| Henry Dunant Hospital Center | Athens | 11526 | Greece |
| General Hospital of Athens "Evangelismos", Department of Critical Care | Athens | Greece |
| University Hospital of Larissa, Department of Critical Care Unit | Thessaloniki | 41110 | Greece |
| Medical Centre, Hungarian Defence Forces, Central Intensive Care Unit and Anesthesiology Department | Budapest | 1134 | Hungary |
| Fejer County St. Gyorgy University Teaching Hospital, Central Department of Anesthesiology and Intensive Care Unit | Szeged | 6725 | Hungary |
| Polyclinic S. Orsola-Malpighi, Department of Organ Impairment and Transplants, Operative Unit of Infectious Diseases | Bologna | 40138 | Italy |
| University Polyclinic Hospital of Modena, Department of General and Specialist Surgery, Operative Unit of Anesthesia and Intensive Care I | Modena | 41124 | Italy |
| University Hospital of Pisa, Department of Gastroenterology and Infectious Diseases, Operative Unit of Infectious Diseases | Pisa | 56124 | Italy |
| University Polyclinic Agostino Gemelli, Complex Operative Unit of Infectious Diseases 2 | Rome | 00168 | Italy |
| Hospital Maggiore University Hospital Ospedali Riuniti of Trieste Dept of ID | Trieste | 34125 | Italy |
| University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases | Udine | 33100 | Italy |
| Craiova County Emergency Clinical Hospital, ATI Clinic | Craiova | Dolj | 200642 | Romania |
| Institute of Infectious Diseases | Bucharest | Sector 2 | 021105 | Romania |
| Pius Brinzeu County Emergency Clinical Hospital, Anesthesia and Intensive Care Department (Romania) | Timișoara | Timiș County | 300723 | Romania |
| Sfanta Parascheva Parascheva Iasi Clinical Hospital for Infectious Diseases | Iași | 700116 | Romania |
| Kuban State Medical University | Krasnodar | 350063 | Russia |
| Territorial Clinical Hospital | Krasnoyarsk | 660022 | Russia |
| Mariinskaya City Hospital | Saint Petersburg | 191104 | Russia |
| University Hospital Vall d'Hebron (HUVH), Department of Infectious Diseases | Barcelona | Catalonia | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona, Department of Infectious Diseases | Barcelona | Catalonia | 08036 | Spain |
| University Hospital Cruces, Unit of Infectious Diseases | Barakaldo | 48903 | Spain |
| Hospital del Mar, Department of Infectious Diseases | Barcelona | 08003 | 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 |
| University Hospital La Paz | Madrid | 28046 | Spain |
| University Hospital Virgen Macarena | Seville | 41009 | Spain |
| University Hospital Nuestra Senora de Valme, | Seville | 41014 | Spain |
| University Hospital Virgen del Rocio (HUVR) | Seville | Spain |
| University Hospital La Fe | Valencia | 46026 | Spain |
| 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. |
| 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. |
| 32955088 | Derived | Thompson GR, Soriano A, Skoutelis A, Vazquez JA, Honore PM, Horcajada JP, Spapen H, Bassetti M, Ostrosky-Zeichner L, Das AF, Viani RM, Sandison T, Pappas PG. Rezafungin Versus Caspofungin in a Phase 2, Randomized, Double-blind Study for the Treatment of Candidemia and Invasive Candidiasis: The STRIVE Trial. Clin Infect Dis. 2021 Dec 6;73(11):e3647-e3655. doi: 10.1093/cid/ciaa1380. |
| FG001 | Group 2 | Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose |
| FG002 | Group 3 | Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). 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 |
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| NOT COMPLETED |
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|
| Part B |
|
|
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 | Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose |
| BG001 | Group 2 | Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose |
| BG002 | Group 3 | Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). 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 |
| BG003 | 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| |||||||||||
| Diagnosis | Count of Participants | Participants |
| |||||||||||
| Estimated Normalized Creatinine Clearance | Data was not captured at baseline for all subjects, preventing calculation of the normalized creatinine clearance. | Mean | Standard Deviation | mL/min/1.73m^2 |
| |||||||||
| Estimated Normalized Creatinine Clearance | Data was not captured at baseline for all subjects, preventing calculation of the normalized creatinine clearance. | Median | Full Range | mL/min/1.73m^2 |
| |||||||||
| Acute Physiology and Chronic Health Evaluation (APACHE) II Score | The APACHE II score is a validated predictor of mortality in critically ill patients. It can be used as a surrogate measure for severity of illness in a patient and can be used in clinical trials at baseline to estimate the overall severity of illness in a patient population. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Critical Care Medicine 1985 13(10):818-29. APACHE II score = acute physiology score + age points + chronic health points. Minimum score = 0; maximum score = 71. | Data was not captured for all subjects, as some subjects did not have the APACHE II calculation performed. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Acute Physiology and Chronic Health Evaluation (APACHE) II Score | The APACHE II score is a validated predictor of mortality in critically ill patients. It can be used as a surrogate measure for severity of illness in a patient and can be used in clinical trials at baseline to estimate the overall severity of illness in a patient population. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Critical Care Medicine 1985 13(10):818-29. APACHE II score = acute physiology score + age points + chronic health points. Minimum score = 0; maximum score = 71. | Data was not captured for all subjects, as some subjects did not have the APACHE II calculation performed. | Median | Full Range | units on a scale |
| ||||||||
| Acute Physiology and Chronic Health Evaluation (APACHE) II Category | The APACHE II score is a validated predictor of mortality in critically ill patients. It can be used as a surrogate measure for severity of illness in a patient and can be used in clinical trials at baseline to estimate the overall severity of illness in a patient population. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Critical Care Medicine 1985 13(10):818-29. APACHE II score = acute physiology score + age points + chronic health points. Minimum score = 0; maximum score = 71. | 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 | Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities. | Safety Population includes all subjects randomized to treatment and who received any amount of study drug. A total of 202 subjects were included in the Safety Population. | Posted | Count of Participants | Participants | From first dose of study drug through Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia. |
|
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| Primary | Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] | Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline | Posted | Count of Participants | Participants | Day 14 (± 1 day) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Mycological Eradication and Resolution of Systemic Signs | Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population. | Posted | Count of Participants | Participants | Day 5, and Follow-up (FU Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia. |
| |||||||||||||||||||||||||||||||||||
| Secondary | Mycological Eradication | Evaluate mycological success (eradication) in the mITT population. | Posted | Count of Participants | Participants | Day 5, Day 14 (±1 day), and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Clinical Cure | Evaluate clinical cure as assessed by the Investigator in the mITT population. Subjects must meet all of the following requirements:
| Posted | Count of Participants | Participants | Day 14 (±1 day) and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). |
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| Secondary | Evaluate PK (Cmax) | Evaluate maximum plasma concentration (Cmax) (Part A only) | PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 1, 10 minutes before end of infusion (EOI) |
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| Secondary | Evaluate PK (Cmin) | Evaluate minimum plasma concentration (Cmin) (Part A only) | PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 8, predose |
| |||||||||||||||||||||||||||||||||
| Secondary | Evaluate PK (Cmin) | Evaluate minimum plasma concentration (Cmin) (Part A only) | PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 15, predose |
|
Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia).
All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of 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 | Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose | 14 | 81 | 35 | 81 | 70 | 81 |
| EG001 | Group 2 | Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose | 7 | 57 | 28 | 53 | 49 | 53 |
| EG002 | Group 3 | Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). 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 | 13 | 69 | 29 | 68 | 53 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Haemorrhagic anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Right ventricular failure | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colonic fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhagic ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired gastric emptying | Gastrointestinal disorders | Systematic Assessment |
| ||
| Peritoneocutaneous fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Generalised oedema | General disorders | Systematic Assessment |
| ||
| Multiple organ dysfunction syndrome | General disorders | Systematic Assessment |
| ||
| Biloma | Hepatobiliary disorders | Systematic Assessment |
| ||
| Drug-induced liver injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| Abdominal abscess | Infections and infestations | Systematic Assessment |
| ||
| Abscess limb | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Candida sepsis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| Endocarditis candida | Infections and infestations | Systematic Assessment |
| ||
| Escherichia bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Pelvic abscess | Infections and infestations | Systematic Assessment |
| ||
| Peritonitis | Infections and infestations | Systematic Assessment |
| ||
| Peritonitis bacterial | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pulmonary sepsis | Infections and infestations | Systematic Assessment |
| ||
| Renal abscess | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic embolus | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcal bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Systemic candida | Infections and infestations | Systematic Assessment |
| ||
| Urosepsis | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural fistula | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tracheal haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Aspiration bronchial | Investigations | Systematic Assessment |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Depressed level of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Metabolic encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Neurodegenerative disorder | Nervous system disorders | Systematic Assessment |
| ||
| Neurological symptom | Nervous system disorders | Systematic Assessment |
| ||
| Peroneal nerve palsy | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Apnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Arterial haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Shock | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Decubitus ulcer | Skin and subcutaneous tissue disorders | 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 | May 17, 2019 | Sep 4, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058387 | Candidemia |
| D009181 | Mycoses |
| D016469 | Fungemia |
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| 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
| Withdrawal by Subject |
|
| Other |
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| Canada |
|
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| Romania |
|
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| Belgium |
|
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| Hungary |
|
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| United States |
|
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| Italy |
|
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| Bulgaria |
|
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| Russia |
|
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| Spain |
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| Group 3 |
Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). 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 |
|
|
| OG002 |
| Group 3 |
Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). 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 |
|
|
Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). 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 |
|
|
| OG002 | Group 3 | Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). 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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