2024-518607-21-00招募中2 期
ANtibiotic TReatment OPtimisation – randomised controlled trial of Clostridioides difficile infection therapy (ANTROP-I)
Fakultni Nemocnice Bulovka8 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2025年2月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 244
- 试验地点
- 8
- 主要终点
- The non-inferiority/superiority will be assessed using the incidence of CDI recurrence during 60 days after the end of study treatment as the primary endpoint.
研究概览
简要总结
The primary objective is to verify the non-inferiority/superiority of 5-day treatment over the standard 10-day treatment of CDI with oral vancomycin.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult age (≥ 18 years) at the time of enrolment
- •Presence of diarrhoea, i.e. ≥ 3 stools per day and a stool consistency that is not normal for the patient (mushy or watery stool)
- •Conclusive laboratory confirmation of C. difficile infection from a stool sample (i.e. presence of C. difficile antigen [glutamate dehydrogenase, GDH] and toxin [type A/B])
- •Hospitalisation at the time of enrolment
- •Informed consent with participation in the clinical trial
- •Fertile men and women of childbearing potential: Consent with own sexual abstinence during the active treatment phase (10 days).
- •Only for the sub-study: Written informed consent with participation in the sub-study and willingness to provide and collect stool samples repeatedly in the following 6 months.
排除标准
- •Life expectancy of the patient is less than 3 months
- •Ongoing CDI episode is a recurrence (i.e. onset in ≤60 days from the last CDI episode)
- •Known allergy/hypersensitivity to vancomycin or excipients of the investigational medical products
- •Haemodynamic instability, critical condition or need for intensive care
- •Toxic megacolon or need for surgical intervention
- •The patient has started therapy for the current CDI episode with metronidazole, tigecycline, or fidaxomicin, or has already used more than 2 doses of vancomycin.
- •Participation in another interventional clinical trial in the last 30 days or in a period equal to 5 half-lives of the respective investigational drug in that clinical trial, whichever is longer
- •Pregnancy or breastfeeding
结局指标
主要结局
The non-inferiority/superiority will be assessed using the incidence of CDI recurrence during 60 days after the end of study treatment as the primary endpoint.
The non-inferiority/superiority will be assessed using the incidence of CDI recurrence during 60 days after the end of study treatment as the primary endpoint.
次要结局
- Recovery is defined as a sustained clinical improvement in the patient’s overall health status for ≥48 hours, including reduced stool frequency and/or normalisation of consistency, alongside stabilisation or improvement in disease severity parameters (e.g., clinical, laboratory, radiological) and no new severe symptoms. Partial improvements, such as a significant reduction in stool frequency, also reflect treatment efficacy and are perceived as treatment response.
- 16S rRNA genotypes
- The incidence of adverse events, their severity, duration, and relation to vancomycin.
- EXPLORATORY: Additional stool samples from patients will be collected and stored for future research: a. α-diversity dynamics during the sub-study period b. α-diversity value at the end of treatment c. Identification of main trajectories of microbiota recovery during the sub-study period (species-level) d. Presence of multidrug-resistant bacteria by genetic examination.
研究者
Hynek Bartoš
Scientific
Fakultni Nemocnice Bulovka
研究点 (8)
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