LMN-201 用于预防艰难梭菌感染复发
LMN-201 预防艰难梭菌感染复发的 2 期随机、双盲、安慰剂对照研究
This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
-
-
California
-
Escondido、California、美国、90027
- Kaiser Permanente
-
-
Connecticut
-
Hamden、Connecticut、美国、06518
- Gastroenterology Center of Connecticut
-
-
Florida
-
Tampa、Florida、美国、33606
- University of South Florida
-
-
Illinois
-
Burr Ridge、Illinois、美国、60527
- Metro Infectious Disease Consultants, LLC
-
-
Kentucky
-
Lexington、Kentucky、美国、40503
- Baptist Health Research
-
-
Michigan
-
Detroit、Michigan、美国、48202
- Henry Ford Health System
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55455
- University of Minnesota
-
Rochester、Minnesota、美国、55905
- Mayo Clinic - Rochester
-
-
New York
-
New York、New York、美国、10021
- Weill Cornell Medicine
-
-
North Carolina
-
Mount Airy、North Carolina、美国、27030
- IMA Clinical Research
-
-
Texas
-
Houston、Texas、美国、77030
- MD Anderson Cancer Center
-
-
Virginia
-
Annandale、Virginia、美国、22003
- Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC
-
Charlottesville、Virginia、美国、22903
- University of Virginia School of Medicine
-
Springfield、Virginia、美国、22015
- Kaiser Permanente-Mid Atlantic
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792
- UW Health University Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female, aged 18 or older.
- Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5, 6, or 7); a positive stool C. difficile toxin B immunoassay (stool collected no more than 7 days before first dose of LMN-201/placebo), and no other likely explanation for diarrhea. NOTE: Diarrhea is not required to be present on the day of enrollment.
- Provision of signed and dated informed consent form.
- Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7 or fewer days at time of initial study drug administration. SOC antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6)
- May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
- Ability to take oral medication and willingness to adhere to the study medication regimen.
- Stated willingness and ability to comply with all study procedures and availability for the duration of the study and investigator believes individual will complete the study.
- Access to a mobile smartphone.
- For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration.
- For males of reproductive potential: agreement to use condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration.
Exclusion Criteria:
-
Fulminant C. difficile colitis.
-
Admitted or expect to be admitted to an intensive care unit.
-
Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.).
-
Neutropenia (absolute neutrophil count of < 1000 per microliter for any reason).
-
Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the following:
- Bezlotoxumab (Zinplava, Merck & Co.), or another antibody against C. difficile toxin(s)
- C. difficile vaccine
- SER-109 (Seres Therapeutics)
- CP101 (Finch Therapeutics)
- VE303 (Vedanta Therapeutics)
- Fecal microbiota transplant
- Current therapy with oral exchange resins
- Protracted exposure to mu-agonist opioids and/or anticholinergic medication prescribed for diarrheal symptoms (unable to stop mu-agonist opioid treatment unless on a stable dose as of onset of diarrhea and no increase in dose planned for the duration of the study.)
-
Treatment with SOC antibiotic therapy is planned for longer than a 28-day period.
-
Pregnancy, anticipated pregnancy, or breastfeeding.
-
Inability or unwillingness to swallow numerous, relatively large capsules containing study drug or placebo because of a swallowing disorder or dysphagia.
-
Inability to pass swallowed capsules into the distal small intestine because of gastroparesis, repetitive vomiting, or anatomic narrowing in the esophagus, stomach, or small intestine.
-
Psychiatric illness that would affect compliance with medications, study capsules, or follow-up.
-
Status as an inmate, residential mental health program, or residential substance abuse program.
-
Terminal illness with limited life expectancy of less than 24 weeks.
-
Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled.
-
Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the individual, would make it unlikely for the individual to complete the study, or would confound the results of the study.
- Note: Use of probiotics and other food supplements (e.g., yogurt, kefir, kimchi, etc.) are not exclusionary.
- Note: Assuming participants meet all of the inclusion criteria and none of the exclusion criteria, participants with underlying malignancy with a good life expectancy in the study are not excluded.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
Doses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules. |
|
实验性的：哨兵队列
|
LMN-201 consists of orally delivered whole, dried, non-viable biomass of spirulina (Arthrospira platensis) grown from 4 separate strains, each of which has been engineered to express one of the following therapeutic proteins:
|
|
有源比较器：LMN-201
|
LMN-201 consists of orally delivered whole, dried, non-viable biomass of spirulina (Arthrospira platensis) grown from 4 separate strains, each of which has been engineered to express one of the following therapeutic proteins:
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants who achieve global cure
大体时间：Up to 16 weeks after initiation of therapy
|
Proportion of total participants with both successful initial CDI treatment and no CDI recurrence during the Prevention and Observation Phases (by treatment assignment). |
Up to 16 weeks after initiation of therapy
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.