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Complex Ocular Infection, Optimization of Microbiological Diagnosis

Complex Ocular Infection, Optimization of Microbiological Diagnosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05432336
Acronym
ICODIA
Enrollment
153
Registered
2022-06-27
Start date
2023-11-21
Completion date
2026-01-31
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endophthalmitis, Keratitis

Keywords

Endogenous Endophtalmitis, exogenous endophtalmitis, keratitis, PCR, NGS

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTNGS for endohtalmitis / Multiplex PCR for keratitis

For endophtalmitis : optimizing culture and NGS will be realized For keratitis: Multiplex PCR will be added on ocular samples

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Positivity rates of COI samples according to the new protocol2 weeks after taking samplesBefore/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

MeasureTime frameDescription
Time to microbiological diagnosis according to the different technicAt the end of the follow up: 18 monthsAnalysis of a prospective cohort of COI
Accuracy of the different technics according to the gold standard (microbiological culture)At the end of the follow up: 18 monthsAnalysis of a prospective cohort of COI
Microbiological diagnosis of the infectionAt the end of the follow up: 18 monthsAnalysis of a prospective cohort of COI
Cure rateAt the end of the follow up: 18 monthsEvaluation 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.
Modification or not of the anti-infectious treatmentAt the end of the follow up: 18 monthsAnalysis 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
Visual acuityAt the end of the follow up: 18 monthsEvaluation 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.

Countries

France

Contacts

Primary ContactEtienne CANOUI, MD
etienne.canoui@aphp.fr0033158414267
Backup ContactMarie BENHAMMANI-GODARD
marie.godard@aphp.fr0033158411190

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026