Prospective, Randomized, Open-Labeled, Active-Controlled Comparison of Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Treatment efficacy
研究概览
简要总结
This clinical trial compares the use of moxifloxacin versus ceftriaxone in the treatment of primary pyogenic liver abscess. The trial will include nonpregnant adults presenting with primary liver abscess based on clinical diagnosis and computed tomography. The trial aims to determine whether the use of moxifloxacin can effectively treat primary pyogenic liver abscess and shorten hospitalization. This regimen has the additional benefit of avoiding nephrotoxic agents, such as aminoglycosides, used frequently in treatment of pyogenic liver abscess. Development of antibiotic resistance to colonized bacteria in the gastrointestinal tract will also be evaluated using stool cultures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater or equal to 20 years.
- •Clinical diagnosis of liver abscess, supported by an abdominal CT scan, documenting the presence of liver abscess, in the absence of biliary tract stones (except for gallstones without biliary tract dilatation), biliary tract dilatation and biliary tract tumors. Clinical diagnosis of liver abscess includes symptoms of fever, chills, right upper quadrant abdominal pain or knocking tenderness.
- •Read, understood and signed informed consent form.
排除标准
- •Presence of septic metastatic infections to the CNS or eye at presentation.
- •Cultures positive for an organism resistant to study drugs.
- •APACHE II score greater or equal to
- •Co-existent disease considered likely to affect the outcome of the study (e.g., biliary tract stones and malignancy).
- •Patients with ruptured liver abscess
- •Severe hepatic insufficiency (Child-Pugh C) or elevated serum transaminases (GPT) to greater than 5 times the upper limit of normal.
- •Patients who are pregnant or lactating.
- •Known hypersensitivity to b-lactams or fluoroquinolones.
- •Known prolongation of the QT interval.
- •Patients with uncorrected hypokalemia.
- •Patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents
- •Severe, life-threatening disease with a life expectancy of less than 2 months.
- •Pre-treatment with a systemic antibacterial agent for > 24 hours prior to enrollment within 5 days prior to enrollment.
- •Participated in any clinical investigational drug study within 4 weeks of screening.
- •Previously entered in this study.
研究组 & 干预措施
A: Moxifloxacin
Moxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days.
干预措施: Moxifloxacin (Avelox) (Drug)
B: Ceftriaxone
Ceftriaxone 2gm IV every 12 hours for 14 days, then cephalexin 1gm PO every 6 hours for 7 days.
干预措施: ceftriaxone (Drug)
结局指标
主要结局
Treatment efficacy
时间窗: 21 days
次要结局
- All cause mortality(21 days)
- Clinical response(Day 3, 7 and 14)
- Clinical and radiological response(21 days)
- Mortality attributable to liver abscess during treatment(21 days)
- Rates of complication (metastatic infections to the central nervous system and/or eyes)(21 days)
- Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use.(3 months)
研究者
Susan Shin-Jung Lee
Attending physician
Kaohsiung Veterans General Hospital.