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临床试验/NCT03968341
NCT03968341进行中(未招募)不适用

Intraocular Concentrations Study (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis

Fondation Hôpital Saint-Joseph2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
5
试验地点
2
主要终点
Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours)

研究概览

简要总结

Endophthalmitis is an intraocular inflammation due to a serious infection of bacterial, fungal or parasitic origin, involving visual prognosis if it is not treated in time and correctly. Despite the eye isolation from the rest of the body, germs can enter the eye either exogenously, during open globe surgery, following perforating eye trauma, or following anti-VEGF antibodies intravitreal injection, or other drugs such as corticosteroids for example, or by endogenous route, haematogenic as part of sepsis, usually during immunodepression. Post-operative endophthalmitis is the most feared complication following any endo-ocular surgery. It can be acute, occurring within 6 weeks post-operatively or delayed as after poor healing, or on a glaucoma filtration bubble. Endophthalmitis after cataract surgery is a complication with a low incidence of (0.030 to 0.047%) but which, due to interventions number carried out (830,000 in 2016, in France), appears significant. There are factors that favour endophtalmitis occurrence such as a vitreous exit from eyeball during surgical procedure, poor scar coaptation, premature removal of sutures, etc... They condition emergency care. Early diagnosis and appropriate treatment are essential for safeguarding the eye and its function. Therefore, therapeutic management requires endo-ocular sampling in front of any suspicion of endophtalmitis, to be done before any treatment, to carry out microbiological analysis (direct examination on slide, culture, universal and/or targeted PCR, antibiotic susceptibility test). Vitreous puncture is more contributive than anterior chamber puncture, underlining need for these two samples to identify the responsible germ. Once samples have been taken, a broad-spectrum antibiotic therapy introduction must be performed intra-vitreously combined with systemic and local administration. Intravitreal injections allow treatment to be provided at effective concentrations directly at the infection site. On the other hand, toxic risks must be taken into account, especially since the protocol may require multiple intravitreal injections.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Male or female > 18 years old
  • Francophone
  • Patients referred to emergencies by an ophthalmologist or doctor, or patients already hospitalized, with a unfavourable course 48 hours after introduction of broad spectrum probabilistic antibiotic therapy for the following situations:
  • Cataract surgery
  • Vitreoretinal surgery
  • Intravitreal injection [anti-VEGF for the treatment of AMD, dexamethasone (Ozurdex®) for the treatment of cystoid macular edema]
  • Physical signs presence of intraocular inflammation (Tyndall, hypopyon, cyclic membrane, hyalite)
  • Presence of functional signs (Decreased Visual Acuity)
  • Patients for whom a management re-evaluation is essential with obligation of new intraocular samples.
  • Patient affiliated to social security or, failing that, to another health insurance system

排除标准

  • Patient under guardianship or curators
  • Patient deprived of liberty
  • Participation refusal in the study

结局指标

主要结局

Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours)

时间窗: 48 hours

Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours) by liquid chromatography coupled with a high-resolution mass spectrometer (HPLC-HRMS).

次要结局

  • Number of aqueous or vitreous humor samples collected by puncture from treated patients that can be used analytically(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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