Fungal Infection Clinical Trial
— STRIVEOfficial 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
Verified date | December 2020 |
Source | Cidara Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Cidara Therapeutics Inc. |
United States, Belgium, Bulgaria, Canada, Greece, Hungary, Italy, Romania, Russian Federation, Spain,
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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