跳至主要内容
临床试验/NCT07056881
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

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

发起方
Centre Hospitalier de Saint-Denis
申办方类型
Other
责任方
Sponsor

研究点 (1)

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