Phase 2
N=22
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Mycoses · Candidiasis, Invasive · Candidemia
Bottom Line
View on ClinicalTrials.gov: NCT02244606 ↗Enrolled (actual)
22
Serious AEs
42.9%
Results posted
Jun 2024
Primary outcome: Primary: Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements — 1; 1; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SCY-078 (Drug); Fluconazole (Drug); Micafungin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Scynexis, Inc.
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements |
1; 1; 0; 0; 5; 6 | — |
| PRIMARY Dose of SCY-078 That Achieves the Target Exposure (AUC) |
3; 4 | — |
| SECONDARY Global Response |
5; 6; 5; 1; 2; 1 | — |
| SECONDARY Clinical Response |
5; 6; 5; 1; 1; 0 | — |
| SECONDARY Microbiological Response |
6; 6; 6; 1; 0; 0 | — |
| SECONDARY Relapse |
1; 0; 0; 0; 4; 4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02244606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.