2023-506232-32-00招募中2 期
Evaluation of EXL01 a new Live Biotherapeutic Product to prevent recurrence of Clostridioides difficile infection in high-risk patients. LIVEDIFF
Hospices Civils De Lyon, Hospices Civils De Lyon9 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年11月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 9
- 主要终点
- Phase I: Occurrence of serious adverse events (CTCAE grade≥3) during treatment and follow-up and discontinuation due to adverse events attributed to treatment. Phase II: Proportion of patients at S8 after the start of treatment who had a recurrence of toxigenic C. difficile defined as ≥3 loose stools per day for more than 48 hours + detection of C. difficile toxin in stool (enzyme-linked immunosorbent assay or toxigenic culture +/- PCR) resulting in the initiation of specific treatment for CDI.
研究概览
简要总结
Phase I: Evaluation of the safety and tolerability of oral EXL01 Phase II: Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection at S8 in patients at high risk of recurrence
研究设计
- 分配方式
- Randomized
- 主要目的
- Exl01/placebo
- 盲法
- Double (Monitor, Subject, Investigator)
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
- •Patient over 18 years of age
- •3rd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in the stools by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI or 2nd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in the stool by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI with at least one of the following risk factors: - Age ≥70 years - Chronic renal failure (haemodialysis or GFR<60ml/min) - History of severe or severe-complicated CDI (excluding current episode) according to ESCMID 2021 criteria - ≥3 episodes of CDI in the last 12 months (including the current episode) - Care-associated CDI defined as CDI occurring during hospitalisation (<3 months)
- •On current or planned vancomycin treatment per os
- •Patient capable of giving free, informed and written consent
- •Enrolled in the national compulsory social security scheme
排除标准
- •Currently participating or has participated in a study with an investigational compound or device in the 3 months prior to the first dose of the study intervention.
- •HIV AIDS stage
- •Stem cell allograft ≤ 12 months
- •Chronic inflammatory bowel disease
- •Aplasia (<500 PNN/mm3) at inclusion
- •Personal history of gastrointestinal resection other than appendectomy (gastrectomy, oesophagectomy, colonic or small intestine resection, short bowel syndrome)
- •Personal history of microbial overgrowth of the small intestine
- •Hospitalisation in a continuing care unit or intensive care unit
- •Treatment with >20mg prednisone equivalent in the 14 days prior to inclusion (excluding inhaled or topical treatment).
- •Proven celiac disease
- •Current stoma (ileostomy or colostomy) or within the last 6 months or any other intra-abdominal surgery within the 3 months prior to treatment
- •Swallowing disorders making it impossible to take oral treatment
- •major surgery or trauma ≤ 4 weeks before the start of treatment
- •Surgery scheduled during the study requiring perioperative antibiotics.
- •The planned administration during the study of treatment which is expected to cause diarrhoea (chemotherapy, colonic preparation prior to colonoscopy).
- •Antibiotic treatment in progress or planned during the study for an infection other than CDI
- •History of chronic diarrhoea (> 3 liquid stools per day for > 4 weeks) not related to a gastrointestinal infection.
- •Clinically significant medical or surgical condition not mentioned in the above criteria which, in the opinion of the investigator, could interfere with the administration of the study drug, the interpretation of the study safety or efficacy data, or compromise the safety or well-being of the subject.
- •Women without contraception, pregnant or breast-feeding women
- •History of hypersensitivity to EXL01 and/or to any excipient with a known effect (D-mannitol, sucrose, maltodextrin, L-cysteine, L-cysteine hydrochloride, magnesium stearate and hydroxypropylmethylcellulose), and/or soya or products containing soya.
- •History of hypersensitivity to vancomycin mentioned in the local prescribing information.
- •Personal history of faecal microbiota transplantation < 12 months.
- •Participation in another interventional studY. (Patients who have entered the follow-up phase of an interventional study may participate provided that more than 3 months have elapsed since the last intervention.)
- •Person deprived of liberty by a judicial or administrative decision
- •Adults subject to a legal protection measure or unable to express their consent
- •Refractory C. difficile infection defined as lack of response to adequate treatment with oral vancomycin or fidaxomicin with ≥3 liquid stools per day after ≥5 days of treatment
- •Severe C. difficile infection severe (defined by the presence of a white blood cell count >15×10⁹ cells/L or a body temperature >38.5°C or >50% increase in the patient's baseline creatinine related to CDI at the time of V1) and/or complicated (defined by any of the factors attributed to current Clostridioides difficile infection (CDI): hypotension, septic shock, elevated serum lactate, ileus, toxic megacolon, intestinal perforation or any fulminant course of the disease) Translated with DeepL.com (free version)
- •Expected life expectancy of less than 6 months
- •Presents a known psychiatric disorder that would interfere with adequate cooperation with the study requirements.
- •Regular use of illicit or recreational drugs
- •Cirrhosis with Child C score
- •Malignant haemopathy under treatment (excluding CLL)
结局指标
主要结局
Phase I: Occurrence of serious adverse events (CTCAE grade≥3) during treatment and follow-up and discontinuation due to adverse events attributed to treatment. Phase II: Proportion of patients at S8 after the start of treatment who had a recurrence of toxigenic C. difficile defined as ≥3 loose stools per day for more than 48 hours + detection of C. difficile toxin in stool (enzyme-linked immunosorbent assay or toxigenic culture +/- PCR) resulting in the initiation of specific treatment for CDI.
Phase I: Occurrence of serious adverse events (CTCAE grade≥3) during treatment and follow-up and discontinuation due to adverse events attributed to treatment. Phase II: Proportion of patients at S8 after the start of treatment who had a recurrence of toxigenic C. difficile defined as ≥3 loose stools per day for more than 48 hours + detection of C. difficile toxin in stool (enzyme-linked immunosorbent assay or toxigenic culture +/- PCR) resulting in the initiation of specific treatment for CDI.
次要结局
- Phase I: Proportion of patients at S8 after the start of treatment who had a recurrence of toxigenic C. difficile defined as ≥3 liquid stools per day for more than 48 hours + detection of C. difficile toxin in stool (enzyme-linked immunosorbent assay or toxigenic culture +/- PCR) resulting in the initiation of specific treatment for CDI.
- Phase II: Occurrence of adverse events (CTCAE grade≥3) during treatment and follow-up and discontinuation of treatment due to adverse events
- Digestive symptoms are measured at each visit by : o The number of bowel movements per day over the last 24 hours, using the stool calendar o Stool consistency assessed using the Bristol scale over the last 24 hours using the stool calendar o Abdominal discomfort assessed by a validated irritable bowel syndrome scale (IBS-SSS) at S8 and M4
- Patient quality of life at S8 and M4 measured by a quality of life questionnaire validated in digestive diseases (IBS-QOL)
- percentage of patients with a recurrence of C. difficile infection at M4
- Level of F. prausnitzii (qPCR) in stools at S8 versus S0
- Level of F. prausnitzii (qPCR) in faeces at M4 versus S0
- Composition of intestinal microbiota (determined by 16S rRNA sequencing or shotgun) at each visit
- percentage of patients at each visit with a positive fecal toxigenic C. difficile test (PCR) and considered to be in clinical remission
- percentage of patients with a recurrence of C. difficile infection requiring hospitalisation at S8
- percentage of patients with a recurrence of C. difficile infection requiring hospitalisation at M4
- percentage of patients with a recurrence of C. difficile infection requiring surgery at S8
- percentage of patients with a recurrence of C. difficile infection requiring surgery at M4
研究者
Dr Nicolas BENECH
Scientific
Hospices Civils De Lyon
研究点 (9)
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