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

March 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intraocular antibiotic concentrations determination

In the event that the patient develops unfavourably, the ophthalmologist include the patient in the trial.

The patient is reviewed at 48 hours after the introduction of probabilistic antibiotic therapy for clinical reassessment and the return of microbiological test results. Following this inclusion, the new samples will be taken when the patient passes through the operating room for the treatment of his pathology as part of the care. Ophthalmologists may have to adapt the patient's management (i.e. adjustment of antibiotic therapy) as part of their usual care routine. An anterior chamber puncture and a vitrectomy are performed. Eye fluids collected as part of the treatment are sent for analysis.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours)
Time Frame: 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).
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of aqueous or vitreous humor samples collected by puncture from treated patients that can be used analytically
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Collaborators

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Investigators

  • Study Director: François COUDORE, Professor, Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2020

Primary Completion (Actual)

June 8, 2022

Study Completion (Anticipated)

December 8, 2023

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CINEBIOPHTA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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