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Echinocandin

SCY-078 + Fluconazole or Echinocandin for Invasive Candidiasis (MARIO Trial)

Phase 3
Waitlist Available
Research Sponsored by Scynexis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30
Awards & highlights

MARIO Trial Summary

This trial will compare two treatments for a fungal infection called candidemia, which is a bloodstream infection with the Candida fungus. One treatment will be intravenous echinocandin followed by oral ibrexafungerp, and the other treatment will be intravenous echinocandin followed by oral fluconazole. The trial will be double-blind, meaning neither the patients nor the doctors will know which treatment the patients are receiving.

Eligible Conditions
  • Candida Blood Infection
  • Invasive Candidiasis

MARIO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All-cause mortality (US FDA Only)
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
Secondary outcome measures
Global Response at Day 14

Side effects data

From 2018 Phase 2 trial • 186 Patients • NCT03253094
47%
Diarrhoea
25%
Nausea
16%
Abdominal pain
9%
Headache
6%
Blood creatine phosphokinase increased
3%
Abdominal pain upper
3%
Dizziness
3%
Somnolence
3%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrexafungerp 750-mg
Ibrexafungerp 300-mg
Ibrexafungerp 450-mg
Ibrexafungerp 150-mg
Ibrexafungerp 300-mg D1 to D3
Fluconazole

MARIO Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IV echinocandin followed by oral ibrexafungerp (SCY-078)Experimental Treatment2 Interventions
Group II: IV echinocandin followed by oral fluconazoleActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SCY-078
2014
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

Scynexis, Inc.Lead Sponsor
17 Previous Clinical Trials
2,258 Total Patients Enrolled
David Angulo, MDStudy DirectorScynexis, Inc.
7 Previous Clinical Trials
970 Total Patients Enrolled

Media Library

Echinocandin (Echinocandin) Clinical Trial Eligibility Overview. Trial Name: NCT05178862 — Phase 3
Candida Blood Infection Research Study Groups: IV echinocandin followed by oral fluconazole, IV echinocandin followed by oral ibrexafungerp (SCY-078)
Candida Blood Infection Clinical Trial 2023: Echinocandin Highlights & Side Effects. Trial Name: NCT05178862 — Phase 3
Echinocandin (Echinocandin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05178862 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you please list other research that has been done on SCY-078?

"SCY-078 was first researched in 2009 at the Medical University of Vienna. So far, there have been 164 completed trials and 19 ongoing studies. Many of the ongoing studies are taking place in Providence, Rhode island."

Answered by AI

Is this study common in North America?

"This study is based out of Rhode island Hospital, Mercury Street Medical Group, and The Miriam Hospital. Additionally, there are 6 other sites where this trial is being conducted."

Answered by AI

Does SCY-078 have the green light from the FDA?

"There is robust clinical data supporting SCY-078's safety, so it received a score of 3."

Answered by AI

Are there currently any open slots for patients in this trial?

"That is correct. The listing on clinicaltrials.gov shows that this study is recruiting patients. The trial was first advertised on August 3rd, 2022 and was updated August 16th, 2022. There are 220 total spots available at 6 hospitals."

Answered by AI

What infections does SCY-078 typically help cure?

"SCY-078 is the standard treatment for coccidioidomycosis, but it can also be applied to a number of other problems like hematopoietic stem cells, prophylaxis of coccidioidomycosis, and skin irritation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole
2022. "A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05178862.
~10 spots leftby Jun 2024
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