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Trial record 1 of 2 for:    MARIO, Scynexis
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A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole (MARIO)

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ClinicalTrials.gov Identifier: NCT05178862
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Study Description
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Brief Summary:
This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

Condition or disease Intervention/treatment Phase
Candidiasis, Invasive Candidemia Drug: SCY-078 Drug: Fluconazole Drug: Echinocandin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)
Actual Study Start Date : August 3, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
Drug Information available for: Fluconazole

Arms and Interventions
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Arm Intervention/treatment
Experimental: IV echinocandin followed by oral ibrexafungerp (SCY-078) Drug: SCY-078
Oral ibrexafungerp (SCY-078) as step-down therapy.
Other Name: Ibrexafungerp

Drug: Echinocandin
Intravenous echinocandin
Other Names:
  • Caspofungin
  • Micafungin
  • Anidulafungin
Active Comparator: IV echinocandin followed by oral fluconazole Drug: Fluconazole
Oral fluconazole (SCY-078) as step-down therapy.
Other Name: Diflucan

Drug: Echinocandin
Intravenous echinocandin
Other Names:
  • Caspofungin
  • Micafungin
  • Anidulafungin


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Day 30 ]
    Demonstrate IV echinocandin followed by oral ibrexafungerp is non-interior to IV echinocandin followed by fluconazole based on 30-day all-cause mortality.


Secondary Outcome Measures :
  1. Successful Global Response (clinical, radiological, and mycological response) [ Time Frame: Day 14 ]
    Demonstrate IV echinocandin followed by oral ibrexafungerp is non-interior to IV echinocandin followed by fluconazole based on Global Response at Day 14


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
  • Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).

Key Exclusion Criteria:

  • Subject has any of the following forms of invasive candidiasis at Screening:

    • Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
    • Osteomyelitis,
    • Endocarditis or myocarditis,
    • Meningitis, endophthalmitis, or any central nervous system infection,
    • Chronic disseminated candidiasis,
    • Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
    • Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
    • Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
    • Patients who failed a previous antifungal therapy for the same infection,
    • Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.
  • Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).
  • Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).

  • Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.

    o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.

  • Baseline QTcF ≥ 500 msec.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05178862


Contacts
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Contact: David Angulo, MD +1 201-884-5471 david.angulo@scynexis.com
Contact: Christopher Anastasi 1-917-733-1108 christopher.anastasi@scynexis.com

Locations
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Sponsors and Collaborators
Scynexis, Inc.
Investigators
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Study Director: David Angulo, MD Scynexis, Inc.
More Information
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Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT05178862    
Other Study ID Numbers: SCY-078-302
MSG-20 ( Other Identifier: Mycoses Study Group (MSGERC) )
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Bacterial Infections and Mycoses
Infections
Invasive Fungal Infections
Fungemia
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
Caspofungin
Micafungin
 Anidulafungin
Ibrexafungerp
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors