NCT00860587Unknown不适用
Risk Factors for Colonization and Infection With Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections (IAI). An Open Observational Study
University Hospital, Linkoeping0 个研究点目标入组 200 人开始时间: 2006年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Primary End points for detection of AB-R Colonising index: (a) Proportion of patients colonised with AB-R strains per bacteria species.(b)Proportion of colonising cultures containing AB-R strains per bacteria species.
研究概览
简要总结
The objectives of the study were:
- To study risk factors for colonization and infection with antibiotic resistant bacteria among patients with severe IAI before and after antibiotic treatment and surgical intervention.
- To study species changes in the rectal flora among patients with severe IAI before and after antibiotic treatment and surgical intervention.
- To review guidelines for antibiotic use in participating units.
- To evaluate surgical antibiotic prophylaxis and treatment in relation to risk for colonization and infection with antibiotic resistant bacteria among patients with severe IAI
- To use the results from the study in the process of a more appropriate use of antibiotics in participating units and care of patients with severe IAI.
- To study the dynamics of extended-spectrum beta-lactamase producing and wild-type Enterobacteriaceae in patients with suspected severe intra abdominal infections before, during and after antibiotic treatment.
详细描述
In order to evaluate if standard empirical treatment was adequate in relation to resistance pattern among most prevalent species at admission we need another 70 patients to be included with at least data and cultures from admission.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients with evidence of intra-abdominal infections that require surgical intervention will be eligible.
- •In addition will patients with intra-abdominal abscess confirmed with CT/ultrasound be eligible, but not treated with surgical intervention if estimated to require at least 5 days antibiotic treatment, with a severity needing initial intravenous administration of antibiotics.
排除标准
- •Age under 18 years
结局指标
主要结局
Primary End points for detection of AB-R Colonising index: (a) Proportion of patients colonised with AB-R strains per bacteria species.(b)Proportion of colonising cultures containing AB-R strains per bacteria species.
时间窗: 48 hours - 2 weeks after end of antibiotic treatment
次要结局
- Proportion of patients with SSI other postoperative infections caused by AB-R strains, per infection type and per bacteria species.(48 hours - 2 weeks after end of antibiotic treatment)
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