Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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.

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)

Keywords

Candidiasis, Invasive, Candidemia, Candidiasis, Fluconazole, Caspofungin, Micafungin, Anidulafungin, Ibrexafungerp, Echinocandins, SCY-078, Echinocandin, IV echinocandin followed by oral ibrexafungerp (SCY-078), IV echinocandin followed by oral fluconazole

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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).

You CAN'T join if...

  • 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.

Locations

  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Mercury Street Medical Group, PLLC accepting new patients
    Butte Montana 59701 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Scynexis, Inc.
Links
Sign up for this study
ID
NCT05178862
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 220 study participants
Last Updated