NCT00511212撤回不适用
Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- clinical efficacy
研究概览
简要总结
The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.
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
- •Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow.
- •Patients with >=38 degrees C, >=15,000/mm3 or <=3,000/mm3 of WBC and >=10mg/dL of CRP
- •Patients who have no abscess on the abdominal image
- •Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement
- •Patients who are 20 years old or older
- •Patients who have signed the agreement for participation in this study
排除标准
- •Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products
- •Patients who have a history of shock due to any of the ingredients of Immunoglobulin products
- •Patients who were administered immunoglobulin within 1 month before entry
- •Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement
- •Patients with IgA deficiency
- •Patients with hereditary fructose intolerance
- •Patients with history of allergy or adverse effect for antibacterial agents
- •Patients who have underlying or concomitant disease that may seriously affect the assessment of this study
- •Patients who are or could be pregnant
- •Patients who have noninfectious fever, fungal infection or viral illness
- •Other patients who are judged to be inadequate to participate in this study by their physician
结局指标
主要结局
clinical efficacy
时间窗: at day 7
次要结局
- clinical efficacy, recurrence rate, mortality, time between drug administration and defervescence, defervescence rate,time between drug administration and disappearance of clinical symptoms, improvement rate on clinical symptoms(at day 3 and at the end of test drug administration,)
研究者
研究点 (2)
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