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Trial record 3 of 10 for:    cd101

CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis (STRIVE)

This study is currently recruiting participants.
Verified October 2017 by Cidara Therapeutics Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02734862
First Posted: April 12, 2016
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cidara Therapeutics Inc.
  Purpose
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).

Condition Intervention Phase
Candidemia Mycoses Fungal Infection Fungemia Invasive Candidiasis Drug: CD101 Drug: Caspofungin Drug: Fluconazole Drug: intravenous placebo Drug: oral placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cidara Therapeutics Inc.:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events [safety and tolerability] [ Time Frame: Day 45- 52 for subjects with candidemia only or Day 52- 59 for subjects with invasive candidiasis with or without candidemia ]
    Number of subjects with treatment emergent adverse events, clinical chemistry, hematology, and urine analysis laboratory tests, vital signs, physical exams, and ECG abnormalities

  • Mycological eradication or presumed mycological eradication [ Time Frame: Day 14 (+/- 1 day) ]
    Number of subjects with negative blood culture(s) for yeast or Candida and no change of antifungal therapy for treatment of candidemia or number of subjects in whom no follow-up culture is available with no change of antifungal treatment for invasive candidiasis and resolution of or improvement of any baseline radiographic abnormalities due to invasive candidiasis

  • Resolution of systemic signs attributable to candidemia and/or invasive candidiasis [ Time Frame: Day 14 (+/- 1 day) ]
    Number of subjects with complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline


Secondary Outcome Measures:
  • Mycological eradication or presumed mycological eradication [ Time Frame: Day 5 ]
    Number of subjects with negative blood culture(s) for yeast or Candida and no change of antifungal therapy for treatment of candidemia or number of subjects in whom no follow-up culture is available with no change of antifungal treatment for invasive candidiasis and resolution of or improvement of any baseline radiographic abnormalities due to invasive candidiasis

  • Resolution of systemic signs attributable to candidemia and/or invasive candidiasis [ Time Frame: Day 5 ]
    Subjects with no new clinical signs or symptoms attributable to candidemia and/or invasive candidiasis that were present at baseline

  • Survival [ Time Frame: Day 14 (+/- 1 day) ]
    Number of subjects alive

  • Mycological eradication or presumed mycological eradication [ Time Frame: Day 28 (+/- 2 days) for subjects with invasive candidiasis ]
    Number of subjects in whom no follow-up culture is available with no change of antifungal treatment for invasive candidiasis and resolution of or improvement of any baseline radiographic abnormalities due to invasive candidiasis

  • Resolution of systemic signs attributable to candidemia and/or invasive candidiasis [ Time Frame: Day 28 (+/- 2 days) for subjects with invasive candidiasis ]
    Number of subjects with complete resolution of all the systemic signs of candidemia and/or invasive candidiasis that were present at baseline

  • Survival [ Time Frame: Day 28 (+/- 2 days) for subjects with invasive candidiasis ]
    Number of subjects alive

  • Resolution of systemic signs attributable to candidemia and/or invasive candidiasis [ Time Frame: Day 45-52 for subjects with candidemia only or Day 52- 59 for subjects with invasive candidiasis with or without candidemia ]
    Number of subjects with complete resolution of all the systemic signs of candidemia which were present at baseline

  • Mycological eradication or presumed mycological eradication [ Time Frame: Day 45-52 for subjects with candidemia only or Day 52- 59 for subjects with invasive candidiasis with or without candidemia ]
    Number of subjects with negative blood culture(s) for yeast or Candida and no change of antifungal therapy for treatment of candidemia or number of subjects in whom no follow-up culture is available with no change of antifungal treatment for invasive candidiasis and resolution of or improvement of any baseline radiographic abnormalities due to invasive candidiasis

  • Survival [ Time Frame: Day 45-52 for subjects with candidemia only or Day 52- 59 for subjects with invasive candidiasis with or without candidemia ]
    Number of subjects alive


Estimated Enrollment: 114
Actual Study Start Date: July 26, 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1

Subjects in the CD101 IV treatment group 1 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.

Drug: CD101
Intravenous antifungal therapy
Other Names:
  • CD101 Injection
  • CD101 for Injection
Drug: intravenous placebo
normal saline
Other Name: placebo infusion
Drug: oral placebo
microcrystalline cellulose
Other Name: encapsulated cellulose
Experimental: Group 2

Subjects in the CD101 IV treatment group 2 will receive CD101 IV 400 mg on Day 1 and 200 mg on 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 oral step down.

Drug: CD101
Intravenous antifungal therapy
Other Names:
  • CD101 Injection
  • CD101 for Injection
Drug: intravenous placebo
normal saline
Other Name: placebo infusion
Drug: oral placebo
microcrystalline cellulose
Other Name: encapsulated cellulose
Active Comparator: 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.

Drug: Caspofungin
Intravenous antifungal therapy
Other Name: Cancidas
Drug: Fluconazole
oral antifungal therapy
Other Name: generic fluconazole
Drug: intravenous placebo
normal saline
Other Name: placebo infusion

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 agree to use one barrier method of birth control or sexual abstinence
  • 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:

    1. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
    2. Osteomyelitis
    3. Endocarditis or myocarditis
    4. 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734862


Contacts
Contact: Karen Mena (858) 888-7868 clinicaltrialinfo@cidara.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
United States, California
University of California - Davis Recruiting
Davis, California, United States, 95817
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Harper University Hospital Recruiting
Detroit, Michigan, United States, 48201
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, Montana
Mercury Street Medical Recruiting
Butte, Montana, United States, 59701
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
United States, Ohio
Mercy Health - St. Vincent Medical Center Recruiting
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Reading Hospital and Medical Center Recruiting
West Reading, Pennsylvania, United States, 19611
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Virginia Tech, Carillion School of Medicine Recruiting
Roanoke, Virginia, United States, 24016
Belgium
Jules Bordet Institute Recruiting
Brussels, Belgium, 1000
Erasme Hospital Recruiting
Brussels, Belgium, 1070
University Hospital Brussels Recruiting
Brussels, Belgium, 1090
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology Recruiting
Sofia, Bulgaria, 1431
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Burns and Plastic Surgery Clinic, Department of Anesthesiology and Intensive Care Recruiting
Sofia, Bulgaria, 1606
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology, Department of Clinical Hematology Withdrawn
Sofia, Bulgaria, 1756
Canada, Ontario
Hamilton Health Science Recruiting
Hamilton, Ontario, Canada, L8V 1C3
University Health Network at University of Toronto Recruiting
Toronto, Ontario, Canada, MG5 2N2
Canada, Quebec
McGill University Health Centre-Research Institute Recruiting
Montréal, Quebec, Canada, H4A 3J1
Greece
University General Hospital "Attikon", 2nd Department of Critical Care Recruiting
Athens, Chaidari, Greece, 12 462
General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit Recruiting
Athens, Greece, 10676
Laikon General Hospital of Athens Recruiting
Athens, Greece, 115 27
Henry Dunant Hospital Center Not yet recruiting
Athens, Greece, 11526
General Hospital of Athens "Evangelismos", Department of Critical Care Recruiting
Athens, Greece
University Hospital of Larissa, Department of Critical Care Unit Recruiting
Thessaloníki, Greece, 41110
Hungary
Medical Centre, Hungarian Defence Forces, Central Intensive Care Unit and Anesthesiology Department Recruiting
Budapest, Hungary, 1134
Fejer County St. Gyorgy University Teaching Hospital, Central Department of Anesthesiology and Intensive Care Unit Recruiting
Szeged, Hungary, 6725
Italy
Polyclinic S. Orsola-Malpighi, Department of Organ Impairment and Transplants, Operative Unit of Infectious Diseases Recruiting
Bologna, Italy, 40138
University Polyclinic Hospital of Modena, Department of General and Specialist Surgery, Operative Unit of Anesthesia and Intensive Care I Recruiting
Modena, Italy, 41124
University Hospital of Pisa, Department of Gastroenterology and Infectious Diseases, Operative Unit of Infectious Diseases Recruiting
Pisa, Italy, 56124
University Polyclinic Agostino Gemelli, Complex Operative Unit of Infectious Diseases 2 Recruiting
Rome, Italy, 00168
University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases Recruiting
Trieste, Italy, 34125
University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases Recruiting
Udine, Italy, 33100
Russian Federation
Kuban State Medical University Not yet recruiting
Krasnodar, Russian Federation, 350063
Territorial Clinical Hospital Recruiting
Krasnoyarsk, Russian Federation, 660022
Mariinskaya City Hospital Recruiting
Saint Petersburg, Russian Federation, 191104
Spain
University Hospital Vall d'Hebron (HUVH), Department of Infectious Diseases Recruiting
Barcelona, Catalonia, Spain, 08035
Hospital Clinic i Provincial de Barcelona, Department of Infectious Diseases Recruiting
Barcelona, Catalonia, Spain, 08036
University Hospital Cruces, Unit of Infectious Diseases Recruiting
Barakaldo, Spain, 48903
Hospital del Mar, Department of Infectious Diseases Recruiting
Barcelona, Spain, 08003
General University Hospital Gregorio Maranon Recruiting
Madrid, Spain, 28007
University Hospital Ramon y Cajal Recruiting
Madrid, Spain, 28034
University Hospital Clinical San Carlos Recruiting
Madrid, Spain, 28040
University Hospital La Paz Recruiting
Madrid, Spain, 28046
University Hospital Virgen Macarena Recruiting
Sevilla, Spain, 41009
University Hospital Nuestra Senora de Valme, Recruiting
Sevilla, Spain, 41014
University Hospital Virgen del Rocio (HUVR) Recruiting
Sevilla, Spain
Sponsors and Collaborators
Cidara Therapeutics Inc.
Investigators
Study Director: Taylor Sandison, MD MPH Cidara Therapeutics
  More Information

Responsible Party: Cidara Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02734862     History of Changes
Other Study ID Numbers: CD101.IV.2.03
2015-005599-51 ( EudraCT Number )
First Submitted: March 16, 2016
First Posted: April 12, 2016
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cidara Therapeutics Inc.:
mycoses

Additional relevant MeSH terms:
Mycoses
Candidiasis
Candidemia
Candidiasis, Invasive
Fungemia
Sepsis
Infection
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors