Back to resultsCD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (STRIVE)
Primary Purpose
Candidemia, Mycoses, Fungal Infection
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CD101
Caspofungin
Fluconazole
intravenous placebo
oral placebo
Sponsored by
About this trial
This is an interventional treatment trial for Candidemia focused on measuring mycoses
Eligibility Criteria
Inclusion Criteria:
- mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken less than or equal to 96 hours before randomization (defined as: at least 1 blood culture positive for Candida or positive test for Candida from a sponsor approved rapid diagnostic test or positive gram stain for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site)
- willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required. Patients receiving only medications and measures for comfort and not cure should not be enrolled.
- female subjects of child bearing potential <2 years post menopausal must agree to one barrier method and one highly effective method of birth control or sexual abstinence.
- male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm from first dose of CD101 (Day 1) until 90 days following last administration of study drug.
- 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 their behalf.
- presence of one or more systemic signs attributable to candidemia and/or invasive candidiasis
Exclusion Criteria:
Any of the following forms of IC:
- Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
- Osteomyelitis
- Endocarditis or myocarditis
- Meningitis, endophthalmitis, or any central nervous system infection
- 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
Sites / Locations
- University of Alabama at Birmingham
- University of California - Davis
- University of Miami Miller School of Medicine
- Augusta University
- Brigham and Women's Hospital
- Harper University Hospital
- Henry Ford Health System
- William Beaumont Hospital
- University of Mississippi Medical Center
- Washington University School of Medicine
- Mercury Street Medical
- Albany Medical Center
- Mercy Health - St. Vincent Medical Center - ID Clinical Research
- Reading Hospital and Medical Center
- University of Texas Health Science Center at Houston
- Virginia Tech, Carillion School of Medicine
- Jules Bordet Institute
- CHU Brugman
- Erasme Hospital
- UCL Saint-LUC
- UZ Gent Algemene Inwendige Zietken
- University Hospital Brussels
- University Hospital Leuven
- CHU Sart-Tillman
- University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
- University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Burns and Plastic Surgery Clinic, Department of Anesthesiology and Intensive Care
- Juravinski Hospital and Cancer Centre/Hamilton Health Sciences
- Toronto General Hospital-University Health Network
- CIUSSS de L'Est-de-l'Île-De-Montréal, Installation Hôpital
- McGill University Health Centre-Research Institute
- University General Hospital "Attikon", 2nd Department of Critical Care
- General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
- Laiko General Hospital of Athens
- Henry Dunant Hospital Center
- General Hospital of Athens "Evangelismos", Department of Critical Care
- University Hospital of Larissa, Department of Critical Care Unit
- Medical Centre, Hungarian Defence Forces, Central Intensive Care Unit and Anesthesiology Department
- Fejer County St. Gyorgy University Teaching Hospital, Central Department of Anesthesiology and Intensive Care Unit
- Polyclinic S. Orsola-Malpighi, Department of Organ Impairment and Transplants, Operative Unit of Infectious Diseases
- University Polyclinic Hospital of Modena, Department of General and Specialist Surgery, Operative Unit of Anesthesia and Intensive Care I
- University Hospital of Pisa, Department of Gastroenterology and Infectious Diseases, Operative Unit of Infectious Diseases
- University Polyclinic Agostino Gemelli, Complex Operative Unit of Infectious Diseases 2
- Hospital Maggiore University Hospital Ospedali Riuniti of Trieste Dept of ID
- University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases
- Craiova County Emergency Clinical Hospital, ATI Clinic
- Institute of Infectious Diseases
- Pius Brinzeu County Emergency Clinical Hospital, Anesthesia and Intensive Care Department (Romania)
- Sfanta Parascheva Parascheva Iasi Clinical Hospital for Infectious Diseases
- Kuban State Medical University
- Territorial Clinical Hospital
- Mariinskaya City Hospital
- University Hospital Vall d'Hebron (HUVH), Department of Infectious Diseases
- Hospital Clinic i Provincial de Barcelona, Department of Infectious Diseases
- University Hospital Cruces, Unit of Infectious Diseases
- Hospital del Mar, Department of Infectious Diseases
- General University Hospital Gregorio Maranon
- University Hospital Ramon y Cajal
- University Hospital Clinical San Carlos
- University Hospital La Paz
- University Hospital Virgen Macarena
- University Hospital Nuestra Senora de Valme,
- University Hospital Virgen del Rocio (HUVR)
- University Hospital La Fe
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Group 1
Group 3
Group 2
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
Mycological Eradication
Evaluate mycological success (eradication) in the mITT population.
Clinical Cure
Evaluate clinical cure as assessed by the Investigator in the mITT population. Subjects must meet all of the following requirements:
Resolution of attributable systemic signs and symptoms of candidemia/IC that were present at baseline
No new systemic signs or symptoms attributable to candidemia/IC
No additional systemic antifungal therapy administered for candidemia/IC
The subject is alive
Evaluate PK (Cmax)
Evaluate maximum plasma concentration (Cmax) (Part A only)
Evaluate PK (Cmin)
Evaluate minimum plasma concentration (Cmin) (Part A only)
Evaluate PK (Cmin)
Evaluate minimum plasma concentration (Cmin) (Part A only)
Full Information
NCT ID
NCT02734862
First Posted
March 16, 2016
Last Updated
December 4, 2020
Sponsor
Cidara Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02734862
Brief Title
CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
Acronym
STRIVE
Official Title
A Phase 2, Multicenter, Randomized, Double-blind Study of the Safety, Tolerability, and Efficacy of Intravenous CD101 vs Intravenous Caspofungin Followed by Oral Fluconazole Step-down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 26, 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cidara Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidemia, Mycoses, Fungal Infection, Fungemia, Invasive Candidiasis
Keywords
mycoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CD101
Other Intervention Name(s)
CD101 for Injection
Intervention Description
Intravenous antifungal therapy
Intervention Type
Drug
Intervention Name(s)
Caspofungin
Other Intervention Name(s)
Cancidas
Intervention Description
Intravenous antifungal therapy
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
generic fluconazole
Intervention Description
oral antifungal therapy
Intervention Type
Drug
Intervention Name(s)
intravenous placebo
Other Intervention Name(s)
placebo infusion
Intervention Description
normal saline
Intervention Type
Drug
Intervention Name(s)
oral placebo
Other Intervention Name(s)
encapsulated cellulose
Intervention Description
microcrystalline cellulose
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
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.
Title
Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success]
Description
Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline
Time Frame
Day 14 (± 1 day)
Secondary Outcome Measure Information:
Title
Mycological Eradication and Resolution of Systemic Signs
Description
Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population.
Time Frame
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.
Title
Mycological Eradication
Description
Evaluate mycological success (eradication) in the mITT population.
Time Frame
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)
Title
Clinical Cure
Description
Evaluate clinical cure as assessed by the Investigator in the mITT population. Subjects must meet all of the following requirements:
Resolution of attributable systemic signs and symptoms of candidemia/IC that were present at baseline
No new systemic signs or symptoms attributable to candidemia/IC
No additional systemic antifungal therapy administered for candidemia/IC
The subject is alive
Time Frame
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).
Title
Evaluate PK (Cmax)
Description
Evaluate maximum plasma concentration (Cmax) (Part A only)
Time Frame
Day 1, 10 minutes before end of infusion (EOI)
Title
Evaluate PK (Cmin)
Description
Evaluate minimum plasma concentration (Cmin) (Part A only)
Time Frame
Day 8, predose
Title
Evaluate PK (Cmin)
Description
Evaluate minimum plasma concentration (Cmin) (Part A only)
Time Frame
Day 15, predose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken less than or equal to 96 hours before randomization (defined as: at least 1 blood culture positive for Candida or positive test for Candida from a sponsor approved rapid diagnostic test or positive gram stain for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site)
willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required. Patients receiving only medications and measures for comfort and not cure should not be enrolled.
female subjects of child bearing potential <2 years post menopausal must agree to one barrier method and one highly effective method of birth control or sexual abstinence.
male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm from first dose of CD101 (Day 1) until 90 days following last administration of study drug.
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 their behalf.
presence of one or more systemic signs attributable to candidemia and/or invasive candidiasis
Exclusion Criteria:
Any of the following forms of IC:
Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
Osteomyelitis
Endocarditis or myocarditis
Meningitis, endophthalmitis, or any central nervous system infection
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taylor Sandison, MD MPH
Organizational Affiliation
Cidara Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California - Davis
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Harper University Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Mercy Health - St. Vincent Medical Center - ID Clinical Research
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Reading Hospital and Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Tech, Carillion School of Medicine
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Jules Bordet Institute
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU Brugman
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UCL Saint-LUC
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent Algemene Inwendige Zietken
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Brussels
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart-Tillman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Burns and Plastic Surgery Clinic, Department of Anesthesiology and Intensive Care
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Juravinski Hospital and Cancer Centre/Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Toronto General Hospital-University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
CIUSSS de L'Est-de-l'Île-De-Montréal, Installation Hôpital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill University Health Centre-Research Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
University General Hospital "Attikon", 2nd Department of Critical Care
City
Athens
State/Province
Chaidari
ZIP/Postal Code
12 462
Country
Greece
Facility Name
General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Laiko General Hospital of Athens
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Henry Dunant Hospital Center
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
General Hospital of Athens "Evangelismos", Department of Critical Care
City
Athens
Country
Greece
Facility Name
University Hospital of Larissa, Department of Critical Care Unit
City
Thessaloníki
ZIP/Postal Code
41110
Country
Greece
Facility Name
Medical Centre, Hungarian Defence Forces, Central Intensive Care Unit and Anesthesiology Department
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Fejer County St. Gyorgy University Teaching Hospital, Central Department of Anesthesiology and Intensive Care Unit
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Polyclinic S. Orsola-Malpighi, Department of Organ Impairment and Transplants, Operative Unit of Infectious Diseases
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
University Polyclinic Hospital of Modena, Department of General and Specialist Surgery, Operative Unit of Anesthesia and Intensive Care I
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
University Hospital of Pisa, Department of Gastroenterology and Infectious Diseases, Operative Unit of Infectious Diseases
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
University Polyclinic Agostino Gemelli, Complex Operative Unit of Infectious Diseases 2
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Hospital Maggiore University Hospital Ospedali Riuniti of Trieste Dept of ID
City
Trieste
ZIP/Postal Code
34125
Country
Italy
Facility Name
University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Craiova County Emergency Clinical Hospital, ATI Clinic
City
Craiova
State/Province
Dolj County
ZIP/Postal Code
200642
Country
Romania
Facility Name
Institute of Infectious Diseases
City
Bucharest
State/Province
Sector 2
ZIP/Postal Code
021105
Country
Romania
Facility Name
Pius Brinzeu County Emergency Clinical Hospital, Anesthesia and Intensive Care Department (Romania)
City
Timişoara
State/Province
Timis County
ZIP/Postal Code
300723
Country
Romania
Facility Name
Sfanta Parascheva Parascheva Iasi Clinical Hospital for Infectious Diseases
City
Iaşi
ZIP/Postal Code
700116
Country
Romania
Facility Name
Kuban State Medical University
City
Krasnodar
ZIP/Postal Code
350063
Country
Russian Federation
Facility Name
Territorial Clinical Hospital
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Mariinskaya City Hospital
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
University Hospital Vall d'Hebron (HUVH), Department of Infectious Diseases
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona, Department of Infectious Diseases
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
Facility Name
University Hospital Cruces, Unit of Infectious Diseases
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital del Mar, Department of Infectious Diseases
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
General University Hospital Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
University Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
University Hospital Clinical San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
University Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
University Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
University Hospital Nuestra Senora de Valme,
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
University Hospital Virgen del Rocio (HUVR)
City
Sevilla
Country
Spain
Facility Name
University Hospital La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32955088
Citation
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. Erratum In: Clin Infect Dis. 2021 Aug 2;73(3):561-562.
Results Reference
derived
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CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
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