EUCTR2022-000648-32-GR进行中（未招募）1 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 (MARIO) - MARIO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- 性别
- All
入选标准
- •KEY INCLUSION CRITERIA
- •Subjects must fulfill all of the following KEY criteria at Screening to be eligible for participating in the study:
- •1. Subject is a male or female adult = 18 years of age on the day the study informed consent is signed.
- •2. 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 within ± 4
- •days (96 hours) of initiation of IV echinocandin accompanied by any related clinical sign and/or symptom (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation, etc.).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 192
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •KEY EXCLUSION CRITERIA
- •A subject will be excluded from participation in the study if he or she meets any of the following KEY exclusion 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 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.
- •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.
- •a. 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 has a known history of allergy, hypersensitivity or serious reaction to ibrexafungerp, any of the azole or echinocandin class of antifungal and/or fluconazole or to any of the components of the formulations.
研究者
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