Complex Ocular Infection, Optimization of Microbiological Diagnosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient
Corneal abscess requiring hospitalization
Any suspicion of endogenous or exogenous endophthalmitis.
Patient not opposed to participating in the research
Disqualifiers
Patient under guardianship or curatorship
Pregnant women
Trial population
Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NGS for endohtalmitis / Multiplex PCR for keratitis
Diagnostic testFor endophtalmitis : optimizing culture and NGS will be realized For keratitis: Multiplex PCR will be added on ocular samples
Treatment groups
153 Participants
are divided into 1 treatment groupGroup A: Complex ocular infections (COI)1 intervention
Trial outcomes
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
Time frame
2 weeks after taking samplesSecondary outcomes
1
Microbiological diagnosis of the infection
Analysis of a prospective cohort of COI
Time frame
At the end of the follow up: 18 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov