A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole


About this study

The purpose of this study is 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 30-day all-cause mortality (ACM).

Furthermore, 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 Global Response (clinical, radiological, and mycological response, as confirmed by the Data Review Committee [DRC]) at Day 14

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

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

- 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.

Eligibility last updated 6/13/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paschalis Vergidis, M.D.

Open for enrollment

Contact information:

Jasmine Sexton CCRP

(507) 538-7178


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