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NCT Number: NCT05432336

Complex Ocular Infection, Optimization of Microbiological Diagnosis

The purpose of this study is to evaluate the impact of different technique to optimize the microbiological diagnosis of the COI.

* Metagenomic for the endophtalmitis * Multiplex polymerase chain reaction for corneal abscesses

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Key information

Conditions

Endophthalmitis Corneal Diseases Eye Diseases Eye Infections Infections Keratitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Microbiological diagnosis of complex ocular infection (COI) (i.e: endophtalmitis and corneal abscess) is a current challenge. Indeed, endophtalmitis are often germ-free because a lack of microbiological diagnosis due to small volume to analyze and a complex site to attain. The microbiological etiologies of corneal abscesses are more frequently identified.

Since few years, new molecular tools are developed in infectious diseases to optimizing the microbiological diagnosis. The investigators implemented these techniques in our hospital to optimize the microbiological diagnosis of complex ocular infection (COI). Thus, endophtalmitis benefit, when the volume of the ocular sample is sufficient, of molecular techniques (16s PCR and metagenomic shotgun). Corneal abscesses could shortly benefit of multiplex PCR in order to reduce the time to diagnosis.

The impact and accuracy of these techniques is unknown.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient
  • Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis:
  • Corneal abscess requiring hospitalization
  • Any suspicion of endogenous or exogenous endophthalmitis.
  • Patient not opposed to participating in the research

Exclusion criteria

  • Patient under guardianship or curatorship
  • Pregnant women

Treatment and study plan

NGS for endohtalmitis / Multiplex PCR for keratitis

Diagnostic Test

For endophtalmitis : optimizing culture and NGS will be realized

For keratitis: Multiplex PCR will be added on ocular samples

Other names: Bundle of intervervention to optimizing diagnosis of ocular complex infections

Primary outcomes

  1. Positivity rates of COI samples according to the new protocol

    Time frame: 2 weeks after taking samples

    Before/after type comparison. Comparison of the positivity rates of COI samples according to the new protocol: (i) for endophthalmitis performing a vitreous puncture (PV) or an anterior chamber puncture (PCA), or corneal scraping, optimized with modification of microbiological techniques (culture on enriched medium alone associated with shotgun metagenomics), (ii) for severe corneal abscesses, addition to standard microbiological techniques of molecular biology tests (multiplex PCR and / or metagenomics).

    An COI will be considered with a positive microbiological diagnosis after multidisciplinary concertation considering the different results

Secondary outcomes

  1. Microbiological diagnosis of the infection

    Time frame: At the end of the follow up: 18 months

    Analysis of a prospective cohort of COI

  2. Time to microbiological diagnosis according to the different technic

    Time frame: At the end of the follow up: 18 months

    Analysis of a prospective cohort of COI

  3. Accuracy of the different technics according to the gold standard (microbiological culture)

    Time frame: At the end of the follow up: 18 months

    Analysis of a prospective cohort of COI

  4. Visual acuity

    Time frame: At the end of the follow up: 18 months

    Evaluation of visual acuity at the end of treatment and the cure rate. The investigators hypothesized that the improvement of the microbiological diagnosis allows an improvement of the therapeutic management and thus of the visual outcome.

  5. Cure rate

    Time frame: At the end of the follow up: 18 months

    Evaluation of visual acuity at the end of treatment and the cure rate. The investigators hypothesized that the improvement of the microbiological diagnosis allows an improvement of the therapeutic management and thus of the visual outcome.

  6. Modification or not of the anti-infectious treatment

    Time frame: At the end of the follow up: 18 months

    Analysis of the impact of microbiological diagnosis on the choice of anti-infectious molecules..

    The investigators hypothesized that the improvement of the microbiological diagnosis and the implementation of the COI management bundle will induce a modification of the prescription of anti-infectious molecules. The investigators will realize a qualitative and quantitative analysis of prescribed anti-infective molecules

Study contacts

Contact information is provided by the study sponsor or research team.

Etienne CANOUI, MD

CONTACT

[email protected]

0033158414267

Marie BENHAMMANI-GODARD

CONTACT

[email protected]

0033158411190

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: ICODIA

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 27, 2022
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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