NCT03710694已完成不适用
A European Multicenter, Randomized, Parallel-group Study to Evaluate the Safety and Efficacy/Performance of DAV132 in Hospitalized Patients at High Risk for Clostridium Difficile Infection and Who Receive Fluoroquinolones for the Treatment of Acute Infections
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Da Volterra
- 入组人数
- 260
- 试验地点
- 58
- 主要终点
- Safety endpoint: Proportion of patients having at least one adverse event (AE) related to DAV132 and/or to fluoroquinolones (FQs) and which relationship to product (DAV132 or FQ) is confirmed by the Independent Adjudication Committee (IAC).
研究概览
简要总结
The purpose of this study is to determine the safe use and evaluate the efficacy/performance of DAV132 in hospitalized patients at high risk for Clostridium difficile infection (CDI) and who receive fluoroquinolones (FQs) for the treatment of acute infections or for prophylaxis of febrile neutropenia.
详细描述
Da Volterra develops DAV132, a novel therapeutic option preserving the intestinal microbiota, to prevent potentially life-threatening conditions such as CDI or emergence of antibiotic-resistant bacteria. Prevention of CDI remains critical unmet need, especially for patients at high risk of developing such infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Eligible patients for this study will be excluded if any of the following conditions are present:
- •Antibacterial treatment within seven days before randomization
- •Fluoroquinolone indication other than LRTI, cUTI, or febrile neutropenia prophylaxis
- •Patients with suspected or diagnosed CDI at screening, and/or receiving a treatment effective against CDI
- •Patients with diarrhea corresponding to Bristol stool chart types 5-7, combined with a stool frequency of at least three stools in 24 or fewer consecutive hours, regardless of its etiology
- •Patients using probiotics for prevention of CDI and refusing to stop them at inclusion and during the study
- •Patients currently taking activated charcoal
- •Patients who have received a fecal microbial transplantation within the last 90 days prior to study screening
- •A critically ill patient for whom transfer to an intensive care unit is scheduled, or patient who may likely have critical clinical deterioration within 48 hours;
- •Patients with serious, uncontrolled disease, including but not limited to neutropenia expected to last >7 days (Investigator discretion) or with an estimated life expectancy shorter than 6 months
- •Patients diagnosed with any cancer requiring taxane-based chemotherapy
- •Patients with digestive stoma, known conditions at risk for intestinal obstruction, or known achlorhydria
- •Contra-indication to oral therapy (eg, severe nausea/vomiting or ileus) or patient having tube feeding
- •Patients unable or expected to be unable within 48 hours to receive a medication by oral route administration
- •Known hypersensitivity to the activated charcoal, or to any of the constituents or excipients of DAV132
- •Patients taking any drug/medication acting on (eg, metronidazole; sulfasalazine) or absorbed in the colon.
- •Female patients planning a pregnancy, pregnant or breastfeeding
- •Patients already included into this study
- •Patients in an exclusion period of a previous study
- •Patients with any social or logistical condition which in the opinion of the Investigator, may interfere with the conduct of the study, such as incapacity to understand well, not willing to collaborate, or cannot easily be contacted after discharge
- •Patients not covered by a health insurance system where applicable and in compliance with the recommendations of the national laws in force relating to biomedical research.
- •Patients under administrative or legal supervision.
研究组 & 干预措施
No DAV132 group
No Intervention
Patients randomized to the No DAV132 arm will receive only fluoroquinolones, according to local standard of care.
DAV132 group
Experimental
Patients randomized to the DAV132 arm will be administered DAV132 concomitantly with fluoroquinolones.
干预措施: DAV132 (Device)
结局指标
主要结局
Safety endpoint: Proportion of patients having at least one adverse event (AE) related to DAV132 and/or to fluoroquinolones (FQs) and which relationship to product (DAV132 or FQ) is confirmed by the Independent Adjudication Committee (IAC).
时间窗: 51 days after randomization
The IAC will review AEs according to the IAC charter, including Clostridium difficile infection (CDI) and antibiotic-associated diarrhea (AAD), in a blinded manner across both treatment groups, and confirm whether each AE is related or not to DAV132 and/or to the FQ received by the patient.
次要结局
- Efficacy/performance endpoint, clinical: Proportion of patients with AAD(51 days after randomization)
- Efficacy/performance endpoint, biological: Levels of β-diversity of the intestinal microbiota(Day 6, 10 days after the end of FQs, and 30 days after the end of FQs)
- Efficacy/performance endpoint, biological: Proportion of patients with acquisition of intestinal colonization by C. difficile (among patients negative at baseline)(up to 10 days after the end of FQs)
- Efficacy/performance endpoint, biological: Proportion of patients with resistant bacteria and/or yeasts in feces(Baseline and up to 10 days after the end of FQs)
- Efficacy/performance endpoint, clinical:Proportion of patients with CDI(51 days after randomization)
- Efficacy/performance endpoint, biological: Level of free fecal concentrations of FQs(Day 1, Day 4, Day 6, 10 days after the end of FQs)
- Efficacy/performance endpoint, biological: Level of α-diversity of the intestinal microbiota(Day 1, Day 6, 10 days after the end of FQs, and 30 days after the end of FQs)
- Efficacy/performance endpoint, biological: Proportion of patients with at least one occurrence of resistant bacteria and yeasts in feces (among patients negative at baseline)(up to 10 days after the end of FQs)
- Safety endpoint: Number of AEs and proportion of patients with at least one AE(51 days after randomization)
- Efficacy/performance endpoint, clinical: Plasma levels of FQs(Day 4)
- Efficacy/performance endpoint, biological: Change from D1 of α-diversity of the intestinal microbiota(Day 6, 10 days after the end of FQs, and 30 days after the end of FQs)
研究者
研究点 (58)
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