CTRI/2023/07/055764尚未招募3 期
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
PSI CRO Pharma India Pvt Ltd7 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2023年8月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 7
- 主要终点
- •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 (or Best Available Therapy [or BAT]).
研究概览
简要总结
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp in patients ≥ 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Patients will be treated with ibrexafungerp for up to 180 days. Treatment beyond 180 days and combination therapy with other antifungal agents may be allowed under special circumstances to be agreed upon by the Investigator and the Sponsor.
Subjects must have a proven or probable fungal disease and meet all study criteria to be considered for enrollment. Eligible subjects must also have documented evidence of failure of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment. Subjects will also be considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, the subject cannot receive approved oral antifungal options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstance
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
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.
- •12.Subject is unlikely to comply with protocol requirements.
- •13.Subject is expected to die from a non-infectious cause within 30 days from the day the study ICF is signed.
- •14.Subject is pregnant or breastfeeding or plans to become pregnant.
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.
- •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.
- •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.
- •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.
- •Subject is unlikely to comply with protocol requirements.
- •Subject is expected to die from a non-infectious cause within 30 days from the day the study ICF is signed.
结局指标
主要结局
•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 (or Best Available Therapy [or BAT]).
时间窗: The primary endpoint of the study is ACM at Day 30 in the ITT population.
次要结局
- Assessment of Recurrence of Baseline Fungal Infection.(Assessment of survival)
研究者
研究点 (7)
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