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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02734862
Other study ID # CD101.IV.2.03
Secondary ID 2015-005599-51
Status Completed
Phase Phase 2
First received
Last updated
Start date July 26, 2016
Est. completion date July 2019

Study information

Verified date December 2020
Source Cidara Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date July 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
CD101
Intravenous antifungal therapy
Caspofungin
Intravenous antifungal therapy
Fluconazole
oral antifungal therapy
intravenous placebo
normal saline
oral placebo
microcrystalline cellulose

Locations

Country Name City State
Belgium CHU Brugman Brussels
Belgium Erasme Hospital Brussels
Belgium Jules Bordet Institute Brussels
Belgium UCL Saint-LUC Brussels
Belgium UZ Gent Algemene Inwendige Zietken Gent
Belgium University Hospital Brussels Jette
Belgium University Hospital Leuven Leuven
Belgium CHU Sart-Tillman Liège
Bulgaria University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology Sofia
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
Canada Juravinski Hospital and Cancer Centre/Hamilton Health Sciences Hamilton Ontario
Canada CIUSSS de L'Est-de-l'Île-De-Montréal, Installation Hôpital Montréal Quebec
Canada McGill University Health Centre-Research Institute Montréal Quebec
Canada Toronto General Hospital-University Health Network Toronto Ontario
Greece General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit Athens
Greece General Hospital of Athens "Evangelismos", Department of Critical Care Athens
Greece Henry Dunant Hospital Center Athens
Greece Laiko General Hospital of Athens Athens
Greece University General Hospital "Attikon", 2nd Department of Critical Care Athens Chaidari
Greece University Hospital of Larissa, Department of Critical Care Unit Thessaloníki
Hungary Medical Centre, Hungarian Defence Forces, Central Intensive Care Unit and Anesthesiology Department Budapest
Hungary Fejer County St. Gyorgy University Teaching Hospital, Central Department of Anesthesiology and Intensive Care Unit Szeged
Italy Polyclinic S. Orsola-Malpighi, Department of Organ Impairment and Transplants, Operative Unit of Infectious Diseases Bologna
Italy University Polyclinic Hospital of Modena, Department of General and Specialist Surgery, Operative Unit of Anesthesia and Intensive Care I Modena
Italy University Hospital of Pisa, Department of Gastroenterology and Infectious Diseases, Operative Unit of Infectious Diseases Pisa
Italy University Polyclinic Agostino Gemelli, Complex Operative Unit of Infectious Diseases 2 Rome
Italy Hospital Maggiore University Hospital Ospedali Riuniti of Trieste Dept of ID Trieste
Italy University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases Udine
Romania Institute of Infectious Diseases Bucharest Sector 2
Romania Craiova County Emergency Clinical Hospital, ATI Clinic Craiova Dolj County
Romania Sfanta Parascheva Parascheva Iasi Clinical Hospital for Infectious Diseases Iasi
Romania Pius Brinzeu County Emergency Clinical Hospital, Anesthesia and Intensive Care Department (Romania) Timisoara Timis County
Russian Federation Kuban State Medical University Krasnodar
Russian Federation Territorial Clinical Hospital Krasnoyarsk
Russian Federation Mariinskaya City Hospital Saint Petersburg
Spain University Hospital Cruces, Unit of Infectious Diseases Barakaldo
Spain Hospital Clinic i Provincial de Barcelona, Department of Infectious Diseases Barcelona Catalonia
Spain Hospital del Mar, Department of Infectious Diseases Barcelona
Spain University Hospital Vall d'Hebron (HUVH), Department of Infectious Diseases Barcelona Catalonia
Spain General University Hospital Gregorio Maranon Madrid
Spain University Hospital Clinical San Carlos Madrid
Spain University Hospital La Paz Madrid
Spain University Hospital Ramon y Cajal Madrid
Spain University Hospital Nuestra Senora de Valme, Sevilla
Spain University Hospital Virgen del Rocio (HUVR) Sevilla
Spain University Hospital Virgen Macarena Sevilla
Spain University Hospital La Fe Valencia
United States Albany Medical Center Albany New York
United States Augusta University Augusta Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Mercury Street Medical Butte Montana
United States University of California - Davis Davis California
United States Harper University Hospital Detroit Michigan
United States Henry Ford Health System Detroit Michigan
United States University of Texas Health Science Center at Houston Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States University of Miami Miller School of Medicine Miami Florida
United States Virginia Tech, Carillion School of Medicine Roanoke Virginia
United States William Beaumont Hospital Royal Oak Michigan
United States Washington University School of Medicine Saint Louis Missouri
United States Mercy Health - St. Vincent Medical Center - ID Clinical Research Toledo Ohio
United States Reading Hospital and Medical Center West Reading Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Cidara Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Greece,  Hungary,  Italy,  Romania,  Russian Federation,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
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. 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.
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 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. 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. 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:
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
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 Evaluate PK (Cmax) Evaluate maximum plasma concentration (Cmax) (Part A only) Day 1, 10 minutes before end of infusion (EOI)
Secondary Evaluate PK (Cmin) Evaluate minimum plasma concentration (Cmin) (Part A only) Day 8, predose
Secondary Evaluate PK (Cmin) Evaluate minimum plasma concentration (Cmin) (Part A only) Day 15, predose
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