NCT07056881招募中不适用
Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa
Centre Hospitalier de Saint-Denis1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年4月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clinical cure rate at the end of antibiotic treatment, defined as resolution of signs and symptoms of infection without need for additional antibiotic therapy or surgical intervention.
研究概览
简要总结
This study looks at how well one antibiotic (monotherapy) works compared to two antibiotics (combination therapy) in treating bone infections caused by Pseudomonas aeruginosa. It includes 300 adult patients who had this type of infection confirmed by lab tests and medical imaging. The goal is to find out if using just one antibiotic is as effective as using two, while also looking at side effects, the need for more surgery, antibiotic resistance, and overall antibiotic use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients (≥18 years old)
- •Diagnosis of osteitis or osteomyelitis due to Pseudomonas aeruginosa
- •Isolation of Pseudomonas aeruginosa from at least one deep, sterile sample (e.g., bone biopsy, joint aspiration)
- •Imaging findings consistent with osteomyelitis (MRI, CT scan, or X-ray)
排除标准
- •No isolation of Pseudomonas aeruginosa
- •No imaging evidence suggestive of osteomyelitis
- •Patients under 18 years of age
结局指标
主要结局
Clinical cure rate at the end of antibiotic treatment, defined as resolution of signs and symptoms of infection without need for additional antibiotic therapy or surgical intervention.
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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