Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: SCY-078 500 mg A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. |
Drug: SCY-078
|
Experimental: SCY-078 750 mg A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. |
Drug: SCY-078
|
Active Comparator: Standard-of-care Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily. |
Drug: Fluconazole
Drug: Micafungin
|
Outcome Measures
Primary Outcome Measures
- 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]
- Dose of SCY-078 that achieves the target exposure (AUC) [during randomized study drug (administered for a maximum of 23 days)]
Secondary Outcome Measures
- Global response [end of all antifungal therapy (administered for a maximum of 28 days)]
- Clinical response [end of all antifungal therapy (administered for a maximum of 28 days)]
- Microbiological response [end of all antifungal therapy (administered for a maximum of 28 days)]
- Relapse [2-weeks and 6-weeks after the end of all antifungal therapy]
Eligibility Criteria
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.
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Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
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Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
2 | UC Davis Medical Center | Sacramento | California | United States | 95817 |
3 | University of Colorado Denver | Aurora | Colorado | United States | 80045 |
4 | University of Miami | Miami | Florida | United States | 33125 |
5 | Georgia Regents University | Augusta | Georgia | United States | 30912 |
6 | University of Chicago | Chicago | Illinois | United States | 60637 |
7 | Johns Hopkins University School of Medicine | Baltimore | Maryland | United States | 21205 |
8 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
9 | Mercury Street Medical Group | Butte | Montana | United States | 59701 |
10 | Albany Medical Center | Albany | New York | United States | 12208 |
11 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
12 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
13 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
14 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
15 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
16 | The Miriam Hospital | Providence | Rhode Island | United States | 02906 |
17 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
18 | Dallas VA Medical Center | Dallas | Texas | United States | 75216 |
19 | Parkland Hospital | Dallas | Texas | United States | 75235 |
20 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
21 | University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
22 | South Texas Veterans Healthcare System | San Antonio | Texas | United States | 78229 |
23 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
24 | University of Utah Hospitals and Clinics | Salt Lake City | Utah | United States | 84112 |
25 | Hospital Militar Central | San Salvador | El Salvador | ||
26 | Hospital Rosales | San Salvador | El Salvador | ||
27 | University of Cologne | Cologne | North Rhine Westphalia | Germany | |
28 | Finca El Palomar | Guatemala | Guatemala | Zona 16 | |
29 | Hospital Mario Catarino Rivas | San Pedro Sula | Cortes | Honduras | |
30 | Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula | San Pedro Sula | Cortes | Honduras |
Sponsors and Collaborators
- Scynexis, Inc.
Investigators
- Study Director: David Angulo, MD, Scynexis, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCY-078-202