CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension

Fungal Infection Clinical Trial

— 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

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
• 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
• 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

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive
• Fungal Infection
• Fungemia
• Invasive Candidiasis
• Mycoses

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