Clinical trial NCT03968341: Study of Intraocular Concentrations (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis
Official title: Intraocular Concentrations Study (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endophthalmitis
Keywords: intraocular concentrations of antibiotics
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
First posted: 2019-05-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours)
timeFrame: 48 hours
Secondary outcomes:
measure: Number of aqueous or vitreous humor samples collected by puncture from treated patients that can be used analytically
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: François COUDORE, Professor
role: STUDY_DIRECTOR
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