Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Mycoses Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244606
• Other study ID #: SCY-078-202
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: August 2016

Study information

• Verified date: October 2020
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive
• Mycoses

Intervention

Drug:
• SCY-078

• Fluconazole

• Micafungin

Locations

Country	Name	City	State
El Salvador	Hospital Militar Central	San Salvador
El Salvador	Hospital Rosales	San Salvador
Germany	University of Cologne	Cologne	North Rhine Westphalia
Guatemala	Finca El Palomar	Guatemala
Honduras	Hospital Mario Catarino Rivas	San Pedro Sula	Cortes
Honduras	Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula	San Pedro Sula	Cortes
United States	Albany Medical Center	Albany	New York
United States	Georgia Regents University	Augusta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Mercury Street Medical Group	Butte	Montana
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	Dallas VA Medical Center	Dallas	Texas
United States	Parkland Hospital	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Miami	Miami	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island
United States	UC Davis Medical Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah Hospitals and Clinics	Salt Lake City	Utah
United States	South Texas Veterans Healthcare System	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Scynexis, Inc.

Countries where clinical trial is conducted

United States,  El Salvador,  Germany,  Guatemala,  Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements		from time of informed consent through 6-weeks after last study drug
Primary	Dose of SCY-078 that achieves the target exposure (AUC)		during randomized study drug (administered for a maximum of 23 days)
Secondary	Global response		end of all antifungal therapy (administered for a maximum of 28 days)
Secondary	Clinical response		end of all antifungal therapy (administered for a maximum of 28 days)
Secondary	Microbiological response		end of all antifungal therapy (administered for a maximum of 28 days)
Secondary	Relapse		2-weeks and 6-weeks after the end of all antifungal therapy