Clinical trial NCT02244606: Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Official title: Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mycoses
Candidiasis, Invasive
Candidemia
Keywords: Invasive Candidiasis
Invasive Candida infections
Candidemia
SCY-078
Micafungin
Fluconazole
Echinocandin
Lead sponsor: Scynexis, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

Detailed description: Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
* Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.

Exclusion Criteria:

* Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
* Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
* Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
* Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.

Primary outcomes:
measure: Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
timeFrame: up to 10 weeks
measure: Dose of SCY-078 That Achieves the Target Exposure (AUC)
timeFrame: 0 to 24 hours post-dose
Secondary outcomes:
measure: Global Response
timeFrame: end of all antifungal therapy (administered for a maximum of 28 days)
measure: Clinical Response
timeFrame: end of all antifungal therapy (administered for a maximum of 28 days)
measure: Microbiological Response
timeFrame: end of all antifungal therapy (administered for a maximum of 28 days)
measure: Relapse
timeFrame: 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Healthcare System
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics
state: Utah
city: San Salvador
country: El Salvador
facility: Hospital Militar Central
city: San Salvador
country: El Salvador
facility: Hospital Rosales
city: Cologne
country: Germany
facility: University of Cologne
state: North Rhine Westphalia
city: Guatemala
country: Guatemala
facility: Finca El Palomar
city: San Pedro Sula
country: Honduras
facility: Hospital Mario Catarino Rivas
state: Cortes
city: San Pedro Sula
country: Honduras
facility: Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula
state: Cortes
Study officials:
affiliation: Scynexis, Inc.
name: David Angulo, MD
role: STUDY_DIRECTOR
References: