Clinical trial NCT02734862: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidemia
Mycoses
Fungal Infection
Fungemia
Invasive Candidiasis
Keywords: mycoses
Lead sponsor: Cidara Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-12
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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:

  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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
timeFrame: 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.
measure: Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success]
timeFrame: Day 14 (± 1 day)
Secondary outcomes:
measure: Mycological Eradication and Resolution of Systemic Signs
timeFrame: 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.
measure: Mycological Eradication
timeFrame: 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)
measure: Clinical Cure
timeFrame: 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).
measure: Evaluate PK (Cmax)
timeFrame: Day 1, 10 minutes before end of infusion (EOI)
measure: Evaluate PK (Cmin)
timeFrame: Day 8, predose
measure: Evaluate PK (Cmin)
timeFrame: Day 15, predose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Davis
country: United States
facility: University of California - Davis
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Harper University Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Toledo
country: United States
facility: Mercy Health - St. Vincent Medical Center - ID Clinical Research
state: Ohio
city: West Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Roanoke
country: United States
facility: Virginia Tech, Carillion School of Medicine
state: Virginia
city: Brussels
country: Belgium
facility: Jules Bordet Institute
city: Brussels
country: Belgium
facility: CHU Brugman
city: Brussels
country: Belgium
facility: Erasme Hospital
city: Brussels
country: Belgium
facility: UCL Saint-LUC
city: Gent
country: Belgium
facility: UZ Gent Algemene Inwendige Zietken
city: Jette
country: Belgium
facility: University Hospital Brussels
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Liège
country: Belgium
facility: CHU Sart-Tillman
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
city: Sofia
country: Bulgaria
facility: 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: Hamilton
country: Canada
facility: Juravinski Hospital and Cancer Centre/Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital-University Health Network
state: Ontario
city: Montréal
country: Canada
facility: CIUSSS de L'Est-de-l'Île-De-Montréal, Installation Hôpital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre-Research Institute
state: Quebec
city: Athens
country: Greece
facility: University General Hospital "Attikon", 2nd Department of Critical Care
state: Chaidari
city: Athens
country: Greece
facility: General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
city: Athens
country: Greece
facility: General Hospital of Athens "Evangelismos", Department of Critical Care
city: Thessaloníki
country: Greece
facility: University Hospital of Larissa, Department of Critical Care Unit
city: Budapest
country: Hungary
facility: Medical Centre, Hungarian Defence Forces, Central Intensive Care Unit and Anesthesiology Department
city: Szeged
country: Hungary
facility: Fejer County St. Gyorgy University Teaching Hospital, Central Department of Anesthesiology and Intensive Care Unit
city: Bologna
country: Italy
facility: Polyclinic S. Orsola-Malpighi, Department of Organ Impairment and Transplants, Operative Unit of Infectious Diseases
city: Modena
country: Italy
facility: University Polyclinic Hospital of Modena, Department of General and Specialist Surgery, Operative Unit of Anesthesia and Intensive Care I
city: Pisa
country: Italy
facility: University Hospital of Pisa, Department of Gastroenterology and Infectious Diseases, Operative Unit of Infectious Diseases
city: Rome
country: Italy
facility: University Polyclinic Agostino Gemelli, Complex Operative Unit of Infectious Diseases 2
city: Trieste
country: Italy
facility: Hospital Maggiore University Hospital Ospedali Riuniti of Trieste Dept of ID
city: Udine
country: Italy
facility: University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases
city: Craiova
country: Romania
facility: Craiova County Emergency Clinical Hospital, ATI Clinic
state: Dolj County
city: Bucharest
country: Romania
facility: Institute of Infectious Diseases
state: Sector 2
city: Timişoara
country: Romania
facility: Pius Brinzeu County Emergency Clinical Hospital, Anesthesia and Intensive Care Department (Romania)
state: Timis County
city: Iaşi
country: Romania
facility: Sfanta Parascheva Parascheva Iasi Clinical Hospital for Infectious Diseases
city: Krasnodar
country: Russian Federation
facility: Kuban State Medical University
city: Krasnoyarsk
country: Russian Federation
facility: Territorial Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: Mariinskaya City Hospital
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron (HUVH), Department of Infectious Diseases
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona, Department of Infectious Diseases
state: Catalonia
city: Barakaldo
country: Spain
facility: University Hospital Cruces, Unit of Infectious Diseases
city: Barcelona
country: Spain
facility: Hospital del Mar, Department of Infectious Diseases
city: Madrid
country: Spain
facility: General University Hospital Gregorio Maranon
city: Madrid
country: Spain
facility: University Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: University Hospital Clinical San Carlos
city: Madrid
country: Spain
facility: University Hospital La Paz
city: Sevilla
country: Spain
facility: University Hospital Virgen Macarena
city: Sevilla
country: Spain
facility: University Hospital Nuestra Senora de Valme,
city: Sevilla
country: Spain
facility: University Hospital Virgen del Rocio (HUVR)
city: Valencia
country: Spain
facility: University Hospital La Fe
Study officials:
affiliation: Cidara Therapeutics
name: Taylor Sandison, MD MPH
role: STUDY_DIRECTOR
References:
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.