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 |
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Recruitment Status :
Suspended
(During a review of manufacturing equipment and cleaning activities at a supplier that manufactured study drug for this study, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance.)
First Posted : January 5, 2022
Last Update Posted : November 18, 2023
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Sponsor:
Scynexis, Inc.
Information provided by (Responsible Party):
Scynexis, Inc.
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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 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 : | June 2024 |
| Estimated Study Completion Date : | August 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Yeast Infections
Drug Information
available for:
Fluconazole
| 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:
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| 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:
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Primary Outcome Measures :
- All-cause mortality (US FDA Only) [ Time Frame: Day 30 ]The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
- Global Response at End of Treatment (EU European Medicines Agency [EMA] Only) [ Time Frame: Up to 6 weeks ]The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Secondary Outcome Measures :
- Global Response at Day 14 [ Time Frame: Day 14 ]The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Information from the National Library of Medicine
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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:
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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).
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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.
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
Locations
Show 72 study locations
Sponsors and Collaborators
Scynexis, Inc.
Investigators
| Study Director: | David Angulo, MD | Scynexis, Inc. |
| 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: | November 18, 2023 |
| Last Verified: | November 2023 |
| 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 |