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

PSI CRO Pharma India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

阶段: 3 期
状态: 尚未招募
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•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.

排除标准

•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. <b

研究者

发起方

PSI CRO Pharma India Pvt Ltd

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