SCY-078-302
Enrolling By Invitation
99 years and younger
All
Phase
N/A
16 participants needed
1 Location
Brief description of study
PRIMARY OBJECTIVE:
To demonstrate that treatment of Invasive Candidiasis/ Candidemia with IV echinocandin followed by oral ibrexafungerp is non-inferior to IV echinocandin followed by oral fluconazole based on 30-day all-cause mortality (ACM).
To demonstrate that treatment of Invasive Candidiasis/ Candidemia with IV echinocandin followed by oral ibrexafungerp is non-inferior to IV echinocandin followed by oral fluconazole based on 30-day all-cause mortality (ACM).
SECONDARY OBJECTIVES:
- To demonstrate that treatment of Invasive Candidiasis/ Candidemia with intravenous (IV) echinocandin followed by oral ibrexafungerp is non-inferior to IV echinocandin followed by oral fluconazole based on Global Response (clinical, radiological and mycological response, as confirmed by the Data Review Committee [DRC]) at Day 14
- To compare the efficacy of the treatment regimens, based on: Global Response at Day 30 and End of Therapy (EOT) as determined by the PI and DRC; Clinical Response as determined by the PI and DRC, Mycological Response as determined by the DRC, no recurrence as determined by the DRC, and fungal-free survival as determined by the DRC.
- To evaluate the safety of the regimens
- To evaluate the pharmacokinetics (PK) of ibrexafungerp All Cause Mortality at Day 30 in the ITT population. - The percentage of subjects with Successful Global Response, as determined by the DRC (based on PI-determined clinical response, mycological response and radiological response [when applicable]) at Day 14.
- The percentage of subjects with Successful Global Response at Day 30 and End of Treatment (EOT) as determined by the PI and the DRC.
- The percentage of subjects with Successful Clinical Response at Day 14 and EOT as determined by the PI and the DRC.
- The percentage of subjects with Successful Mycological Response at Day 14 and EOT as determined by the DRC.
- The percentage of subjects with no recurrence before EOT and at 2 weeks and 6 weeks after EOT as determined by the DRC.
- The percentage of subjects alive with Successful Global Response and no recurrence at 6 weeks after EOT as determined by the DRC.
- Frequency of treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), discontinuations due to AEs, serious adverse events (SAEs), and safety laboratory assessments.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: - 99 Years
-
Gender: All
TBD
Updated on
01 Aug 2024.
Study ID: 851993
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