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Clinical Trials/NCT05432336
NCT05432336
Recruiting
Not Applicable

Complex Ocular Infection, Optimization of Microbiological Diagnosis

Assistance Publique - Hôpitaux de Paris1 site in 1 country153 target enrollmentNovember 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endophthalmitis
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
153
Locations
1
Primary Endpoint
Positivity rates of COI samples according to the new protocol
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 21, 2023
End Date
January 1, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Modification or not of the anti-infectious treatment(At the end of the follow up: 18 months)
  • 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 Sites (1)

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