跳至主要内容
临床试验/2024-520226-10-00
2024-520226-10-00招募中3 期

Evaluation of the efficacy of treatment with mucosal bacterial vaccines(autovaccines) versus suppressive antibiotic treatment in subjects with hip or knee prosthesis infections.

Instituto De Investigacion Marques De Valdecilla1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月23日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Clinical course: Presence of exudate, redness of the wound, pain, or other clinical signs of infection.

研究概览

简要总结

To study in patients with joint prosthesis infection with non-curative intent the clinical relevance of autovaccines administered through the sublingual mucosa in decreasing clinical symptoms and/or progression of infection.

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • Patients over 18 years of age
  • Carriers of hip or knee prosthesis, diagnosed with an active infection
  • Without the possibility of curative treatment
  • Patients who sign the informed consent form
  • Monomicrobial infections

排除标准

  • Patients with the possibility of curative treatment
  • Patients under 18 years of age
  • Polymicrobial infections
  • Fungal or mycobacterial infections
  • Patients with oral corticosteroids with doses higher than 5 mg/day in the three months prior to inclusion

结局指标

主要结局

Clinical course: Presence of exudate, redness of the wound, pain, or other clinical signs of infection.

Clinical course: Presence of exudate, redness of the wound, pain, or other clinical signs of infection.

次要结局

  • Safety assessment: local and systemic adverse events

研究者

发起方
Instituto De Investigacion Marques De Valdecilla
申办方类型
Laboratory/Research/Testing facility
责任方
Principal Investigator
主要研究者

mar garcia

Scientific

Instituto De Investigacion Marques De Valdecilla

研究点 (1)

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