NCT03968341

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endophthalmitis

Interventions

Type	Name	Description
OTHER	Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients	A 5mL dry tube will be taken by puncture of the humeral vein like a conventional blood test. This tube is not usually collected unless specifically requested by the ophthalmologist. This sample will be sent quickly (within two hours) to the CHNO Medical Biology Laboratory for centrifugation, serum separation and storage at -80°C. Samples stored at -80°C will be sent weekly to the Microbiology and Anti-infectives Laboratory at Hospital Paris Saint-Joseph, with the dosage request form duly completed with the usual information.

Timeline

• Start date: 2020-12-09
• Primary completion: 2022-06-08
• Completion: 2023-12-08
• First posted: 2019-05-30
• Last updated: 2023-03-07

Locations

1 site across 1 country: France