An observational study in Endophthalmitis and Keratitis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
The purpose of this study is to evaluate the impact of different technique to optimize the microbiological diagnosis of the COI.
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.
65 studies on the registry are indexed under Endophthalmitis; 9 are open to participants now.
This study's planned enrollment of 153 is above the median of 100 across 20 observational studies indexed under Endophthalmitis.
Browse Endophthalmitis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis
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Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis:
Exclusion Criteria:
All patients with an COI (endophtalmitis or hospitalized keratitis)
Diagnostic Test: NGS 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
Also known as: Bundle of intervervention to optimizing diagnosis of ocular complex infections
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
Time frame: 2 weeks after taking samples
Microbiological diagnosis of the infection
Analysis of a prospective cohort of COI
Time frame: At the end of the follow up: 18 months
Time to microbiological diagnosis according to the different technic
Analysis of a prospective cohort of COI
Time frame: At the end of the follow up: 18 months
Accuracy of the different technics according to the gold standard (microbiological culture)
Analysis of a prospective cohort of COI
Time frame: At the end of the follow up: 18 months
Visual acuity
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.
Time frame: At the end of the follow up: 18 months
Cure rate
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.
Time frame: At the end of the follow up: 18 months
Modification or not of the anti-infectious treatment
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
Time frame: At the end of the follow up: 18 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2023 to primary completion in Jul 2025, 19 months.
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