A Phase 3, Randomized, double-blind study for Patients with Invasive Candidiasis treated With IV Echinocandin followed by either oral Ibrexafungerp or oral fluconazole

Phase 3

Conditions: Health Condition 1: B379- Candidiasis, unspecified

Registration Number: CTRI/2023/07/055764

Lead Sponsor: PSI CRO Pharma India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

a.Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed).

b.Osteomyelitis.

c.Endocarditis or myocarditis.

d.Meningitis, endophthalmitis, or any central nervous system infection.

e.Chronic disseminated candidiasis.

f.Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract.

g.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.

h.Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection.

i.Patients who failed a previous antifungal therapy for the same infection.

j.Subject has an uncontrolled 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.

2.Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).

3.Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).

4.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.

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

5.Patients with baseline QTcF = 500 msec, history or family history of Torsades de Pointes or other conditions that would put the subject at undue risk of development of ventricular arrhythmias (including Torsades de Pointes).

6.Subject is receiving or anticipates to require treatment with the prohibited medications (including prescription and over-the-counter medications, supplements, and herbal products) listed in Section 20.1 (Appendix A).

7.Subject has a known history of allergy, hypersensitivity or serious reaction to ibrexafungerp, any of the azole or echinocandin class of antifungal or to any of the components of the formulations.

8.Subject has received treatment with ibrexafungerp in a previous invasive fungal infection trial.

9.Subject is currently participating in another interventional treatment trial with an investigational agent, has participated in any other investigational study within 30 days (or within 5.5 half-lives of the investigational product, whichever is longer) before signing the ICF, or is using an investigational device at the time of Screening.

10.Subject has any other condition or laboratory abnormality evidencing a major organ system disease that, in the judgment of the PI, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.

11.Subject is an employee of SCYNEXIS, Inc., the investigator or the Contract Research Organization involved in the study, or is an immediate family member (partner, offspring, parent, sibling, or sibling’s offspring) of an employee involved in the study.

Exclusion Criteria