Comparison of short course antimicrobial therapy vs. conventional antimicrobial therapy in patients with complicated intra-abdominal infections- A randomized control trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 2. Recurrent intra-abdominal infection requiring either surgical or percutaneous re-intervention
研究概览
简要总结
Title: Comparison of short course antimicrobial therapy vs. conventional antimicrobial therapy in patients with complicated intra-abdominal infections – A randomized control trial
Rationale: Although published guidelines are recommending benefits of shorter duration antimicrobial therapy in patients with CIAI following source control, due to limited studies , the appropriate duration of therapy remains unclear (1). Short course antimicrobial therapy has an advantage over conventional antimicrobial therapy in terms of reduced hospital stay, less incidence of antimicrobial resistance, increased compliance to the therapy and decreases the expenditure on antibiotics.
Hypothesis: Whether the efficacy of short course antibiotics is comparable with conventional anti-microbial therapy in complicated intra-abdominal infections.
Expected outcome and application:The short course antimicrobial therapy if found to be as efficacious and safe as conventional long-term antimicrobial therapy, will help in cost savings in terms of expenditure for prolonged antimicrobial therapy and shortened length of hospitalization without an increase in the postoperative morbidity. This will also likely improve the patients’ compliance to therapy and reduce the risk of emerging microbial resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of complicated intra-abdominal infections (CIAI) who undergo surgical intervention to achieve adequate source control + one or more of the following:
- •Temperature ≤36C or ≥ 38 C
- •WBC count≤4000 or ≥ 11,000/mm3
- •Gastrointestinal dysfunction due to peritonitis, precluding intake of more than half their normal diet (as an indicator of an ileus).
排除标准
- •Non-perforate, non-gangrenous appendicitis or cholecystitis
- •Infected necrotizing pancreatitis.
- •Primary spontaneous bacterial peritonitis
- •Infection associated with indwelling peritoneal dialysis catheter 5.High likelihood of death within 72h[ Patients in the post operative period who require two ionotropes to maintain hemodynamic stability and are above the age of 65] 6.Pregnancy 7.Concurrent infection requiring more than five days of antimicrobial therapy or various antimicrobial regimen.
- •8.Patients undergoing planned re-laparotomy.
结局指标
主要结局
2. Recurrent intra-abdominal infection requiring either surgical or percutaneous re-intervention
时间窗: 30 days
1. Surgical-site infection,
时间窗: 30 days
between the groups of patients with complicated intra-abdominal infection (CIAI), receiving conventional antimicrobial therapy and short course antimicrobial therapy
时间窗: 30 days
3. 30 day mortality
时间窗: 30 days
次要结局
- To compare the time to the occurrence of the composite primary outcome between the two groups(30 days)
- To compare the duration of antimicrobial therapy for index infection between the two groups(30 days)
- To compare the Antimicrobial-free days at 30 days between the two groups.(30 days)
- To compare the rates of individual primary end point components between the two groups(30 days)