Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Resolution of Diarrhea
研究概览
简要总结
Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. Illness from C. difficile most commonly affects patients in hospitals and long-term care facilities and typically occurs after a patient has received antibiotics.
In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would likely occur in conjunction with neutralization of C. difficile toxins A&B by CASAD. Computer modeling of CASAD performed by Phillips et al. at Texas A&M University supports this hypothesis.
The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care therapy will reduce the duration and severity of diarrhea and other symptoms in patients with C. difficile infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •C. difficile-associated diarrhea at the time of enrollment
- •18 years old and up
- •Ability to take oral medications
- •Negative urine pregnancy test for women of childbearing age
- •Must have the ability to understand and the willingness to provide a written informed consent to participate in the study
排除标准
- •History of known allergy to silicates
- •Patients with signs of toxic megacolon, peritonitis, pseudomembranous colitis or bowel perforation
- •Patients with hypotension (systolic blood pressure < 90 mm Hg) or septic shock requiring pressors
- •Patients with other known causes of diarrhea or colitis
- •Pregnancy or lactation
- •History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up
- •Participation in any other study where the subject is actively taking investigational medication within the last 30 days
- •More than 5 doses of metronidazole or oral vancomycin prior to starting on study drug for the current C. difficile diagnosis. Administration of metronidazole or oral vancomycin for treatment of prior C. difficile diagnosis is not exclusionary as some patients may be experiencing a relapse of C. difficile.
- •Any other antibiotic, toxin-binding agent or fecal transplant used for the treatment of C. difficile prior to or added to the subject's standard-of-care treatment regimen. Use of intravenous vancomycin is not exclusionary.
研究组 & 干预措施
Open Label CASAD
Treatment with CASAD for 14 days
干预措施: Calcium Aluminosilicate Anti-Diarrheal (CASAD) (Drug)
结局指标
主要结局
Resolution of Diarrhea
时间窗: 42 days
To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).
次要结局
- Side-effects and Complications(42 days)
- Stools Per Day(14 days)
- Resolution of Abdominal Pain(14 days)
- Absence of Relapse(42 days)