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临床试验/NCT05202964
NCT05202964招募中不适用

Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Percentage of doses taken at 6 weeks

研究概览

简要总结

Bone and joint infections (BJI) are most often bacterial infections that can occur after surgery or de novo. They are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and significant costs. Treatment of BJI is based on antibiotic therapy, often combined with surgery. Antibiotic therapy, at high doses, lasts a minimum of 6 weeks. It can be responsible for severe adverse effects. These characteristics (prolonged duration, multiple daily doses, and adverse effects) are known to negatively affect treatment adherence in general.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • ≥ 18 years
  • Diagnosis of osteoarticular infection
  • Treatment with at least one oral antibiotic for a minimum expected duration ≥ 6 weeks with an expected end of treatment date
  • Patient who was informed and did not object to participate in the study

排除标准

  • Treatment for BJI with oral antibiotic without end of treatment date
  • treatment for BJI with parenteral antibiotic only
  • patient who doesn't have a telephone number or who doesn't want to give it
  • Adults subject to a legal protection measure
  • Pregnant or breastfeeding women

结局指标

主要结局

Percentage of doses taken at 6 weeks

时间窗: At 6 weeks after surgery

Ratio of the number of doses taken over the theoretical number of doses to be taken over the period

Percentage of doses taken at 3 months

时间窗: at 3 months after surgery

Ratio of the number of doses taken over the theoretical number of doses to be taken over the period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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