Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis: A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 21
- 主要终点
- Frequency at day 28 of CSD's adenitis favorable outcome
研究概览
简要总结
To compare effect of intra-nodal injection of gentamicin versus placebo on the outcome at 28 days of suppurated cat scratch disease's (CSD) lymphadenitis treated by oral azithromycin.
详细描述
Double blind controlled study versus placebo. Patients with suppurated CSD's lymphadenitis will receive immediately after the pus aspiration (performed for a diagnostic purpose) an intra-nodal injection of gentamicin or of placebo (NaCl 0,9%) and be treated with oral azithromycin for 5 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Informed consent
- •Suppurated CSD's adenitis:
- •Suppurated form of adenitis confirmed by echography
- •Serology positive for Immunoglobulin G and/or Immunoglobulin M against B. henselae
排除标准
- •Suppurated adenitis non related to CSD
- •Non-suppurated CSD's adenitis
- •Suppurated CSD's adenitis already fistulized
- •Suspected visceral B. henselae infection (neurologic or ophthalmic symptoms, hepato-splenic or valvular involvement confirmed by echography)
- •Immunodepression (except diabetes)
- •Pregnancy
- •Contraindication to pus aspiration from lymphadenitis (history of bleeding or patient taking curative anticoagulation therapy or platelet count < 50.000/mm3)
- •Contraindication to azithromycin (history of QT interval prolongation, history of liver toxicity of hypersensitivity to macrolides or treatment with ergotamine, dihydroergotamine, bepridil, cisapride, pimozide, mizolastine or colchicine) or to aminoglycosides (myasthenia, history of hypersensitivity to aminoglycosides).
研究组 & 干预措施
Gentamicin
intra-nodal injection of gentamicin
干预措施: gentamicin (Drug)
Placebo
intra-nodal injection of placebo
干预措施: placebo (Drug)
结局指标
主要结局
Frequency at day 28 of CSD's adenitis favorable outcome
时间窗: Day 28
Adenitis favorable outcome characterized as : Reduction of the volume of the adenitis, Without requirement of supplementary needle aspirations after day 7's visit, And without requirement of a surgical excision or incision of the adenitis.
次要结局
- Reduction of the adenitis(from Day 0 to Day 28)
- Surgical action(Day 28)
- Safety of treatment(Day 7 and day 28)
- Fistulization of the adenitis(Day 7 and day 28)
- Protein C reactive(Day 0 and day 7)
- Evaluation of the pain related to the adenitis(between Day 0, Day 7 and Day 28)
- Antibiotic resistance(Day 28)