Complex Ocular Infection, Optimization of Microbiological Diagnosis

NCT05432336 | Recruiting

• 2 other identifiers: APHP2202592021-A02587-34
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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

Conditions

Endophthalmitis; Keratitis

Keywords

Endogenous Endophtalmitis; exogenous endophtalmitis; keratitis; PCR; NGS

Outcome Measures

Primary Outcomes (1)

• Positivity rates of COI samples according to the new protocol

  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

  2 weeks after taking samples

Secondary Outcomes (6)

• Microbiological diagnosis of the infection

  At the end of the follow up: 18 months

• Time to microbiological diagnosis according to the different technic

  At the end of the follow up: 18 months

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

  At the end of the follow up: 18 months

• Visual acuity

  At the end of the follow up: 18 months

• Cure rate

  At the end of the follow up: 18 months

Study Arms (1)

Complex ocular infections (COI)

All patients with an COI (endophtalmitis or hospitalized keratitis)

Diagnostic Test: NGS for endohtalmitis / Multiplex PCR for keratitis

Interventions

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

Also known as: Bundle of intervervention to optimizing diagnosis of ocular complex infections

Complex ocular infections (COI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis

You may qualify if:

• 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

You may not qualify if:

• Patient under guardianship or curatorship
• Pregnant women

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Equipe mobile d'infectiologie, Cochin hospital

Paris, IDF, 75014, France

RECRUITING

MeSH Terms

Conditions

Endophthalmitis; Keratitis

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases; Corneal Diseases

Study Officials

• Etienne CANOUI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne CANOUI, MD

CONTACT

0033158414267; etienne.canoui@aphp.fr

Marie BENHAMMANI-GODARD

CONTACT

0033158411190; marie.godard@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 27, 2022
• Study Start: November 21, 2023
• Primary Completion: July 17, 2025
• Study Completion: January 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

FR (1)