Complex Ocular Infection, Optimization of Microbiological Diagnosis
- Conditions
- EndophthalmitisKeratitis
- Interventions
- Diagnostic Test: NGS for endohtalmitis / Multiplex PCR for keratitis
- Registration Number
- NCT05432336
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 149
-
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
- Patient under guardianship or curatorship
- Pregnant women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Complex ocular infections (COI) NGS for endohtalmitis / Multiplex PCR for keratitis All patients with an COI (endophtalmitis or hospitalized keratitis)
- Primary Outcome Measures
Name Time Method Positivity rates of COI samples according to the new protocol 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) 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 Outcome Measures
Name Time Method Modification or not of the anti-infectious treatment 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 moleculesMicrobiological diagnosis of the infection At the end of the follow up: 18 months Analysis of a prospective cohort of COI
Time to microbiological diagnosis according to the different technic At the end of the follow up: 18 months Analysis 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 months Analysis of a prospective cohort of COI
Visual acuity 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.
Cure rate 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.
Trial Locations
- Locations (1)
Equipe mobile d'infectiologie, Cochin hospital
🇫🇷Paris, IDF, France