A Pilot Study of the Effect of Prophylactic Antibiotics on Hospitalized Patients With Advanced Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Infections
研究概览
简要总结
In this pilot study, the investigators aim to assess feasibility of subject identification and data collection, including specimen processing, as well as the rate of enrollment for a future, larger study of the effect of empiric antibiotics for all patients with advanced cirrhosis admitted to the hospital without an existing indication for new antibiotic use. Specifically, the investigators will assess the incidence of infection after the time of enrollment and associated outcomes. Subjects will be randomly assigned to receive antibiotics vs placebo.
详细描述
Cirrhosis is associated with a state of immune-compromise and progressive decompensation, acute on chronic liver failure (ACLF), and death are often caused by bacterial infections. Different sub-groups of patients with cirrhosis at increased risk, i.e. active upper gastrointestinal hemorrhage, low protein ascites, history of spontaneous bacterial peritonitis (SBP), are known to benefit from prophylactic antibiotics. The investigators hypothesize that hospitalized patients with advanced cirrhosis are also at increased risk and thus may benefit from preventive treatment. Subjects will be randomly assigned to receive an antibiotic vs placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded placebo-controlled trial
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
- •MELD-Na >= 18
- •Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies
排除标准
- •Inability to obtain consent (from subject or next of kin/legal authorized representative (LAR)
- •Allergy to cephalosporins
- •Pregnancy (due to limited prospective data regarding safety of ceftriaxone)
- •Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection
- •Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant)
- •H/o recurrent C difficile infection within the past year (>2) or requiring fecal microbiota transplant (FMT)
- •Enrollment in the study protocol during a previous admission
研究组 & 干预措施
Treatment
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
干预措施: Ceftriaxone (Drug)
Placebo
Normal saline (50cc) once daily for up to one week or until end of hospitalization
干预措施: Normal saline (Drug)
结局指标
主要结局
Infections
时间窗: For 7 days or until end of hospital stay
Incident bacterial infection after enrollment
次要结局
- Length of Stay(Up to 30 days)
- Mortality(Up to 30 days)
- 30-day Mortality(Up to 30-days)
研究者
Zachary Fricker
Instructor, Division of Gastroenterology
Beth Israel Deaconess Medical Center