An observational study in Infectious Keratitis, Microbial Keratitis and Corneal Infection, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by CHU de Reims · Observational
Microbial keratitis is a severe and often blindness-inducing pathology which represents today the first reason for long-term hospitalization (more than 5 days) in ophthalmology. Its diagnosis is clinical and leads to an immediate hospitalization in the presence of serious criteria (Mackie classification). The entire process of microbiological diagnosis requires several days before etiological confirmation and therefore delays the initiation of targeted therapy.
Recently, new PCR systems allowing the detection of 18 to 27 pathogens in 75 minutes have been developed. Their use could thus be transposed to ophthalmology by adapting the microbiological diagnostic technique to samples currently taken by swabbing the cornea.
The investigators will compare their diagnosis performance versus conventional methods on patients who suffered for a microbial keratitis with severity criteria.
46 patients enrolled for severe infectious keratitis will be recruited in the department of Ophthalmology, Robert Debré Hospital, Reims, France. The study will be composed by 2 groups. The first, also called "before group" will contain 23 patients who were anteriorly hospitalized for a severe infectious keratitis in our hospital unit. They received standard microbiological diagnosis methods: Direct microscopic examination with Gram stain, bacterial and fungal cultures, viral and amoebic polymerase chain reaction [PCR]).
The second, also called "after group" will enroll patients who suffer for a severe infectious keratitis (prospective group). Each patient will benefit a complete ophthalmologic examination, corneal scrapping and swabbing for standard microbiological diagnosis methods along with another corneal swabbing sample for the use of two different FilmArray® PCR systems identified as "ME" for Meningitis-Encephalitis and "BCID" for Blood Culture Identification.
The investigators hypothesize that the use of rapid multiplex PCR tests for the microbiological diagnosis of severe corneal infections could in the future prove to be more efficient than the current diagnostic strategy, on the one hand, by shortening the time to identify the pathogen and therefore to implement a targeted treatment, and on the other hand, by systematically searching for a large number of pathogens well beyond those targeted today. In addition, the benefits of this technique applied to ophthalmology could improve the long-term visual prognosis, reduce the length of hospitalization and therefore the diagnostic and management costs of these patients.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's planned enrollment of 46 is below the median of 105 across 31 observational studies indexed under Keratitis.
Browse Keratitis studies →CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients treated for a severe corneal abscess according to the Mackie classification (requiring hospitalization) at the Reims University Hospital between 05/01/2022 and 04/30/2023 ("before" phase) and between 01/ 05/2023 and 04/30/2024 ("after" phase).
Inclusion criteria:
Non-inclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: PCR multiplex by FilmArray
PCR multiplex by FilmArray system on corneal swabbing sample
Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen.
Time frame: At 2 weeks
Duration of hospitalization
Time frame: At 1 month
Best corrected visual acuity
Time frame: At 12 months
Modification of the initial antimicrobial treatment after detection of the etiological agent
Time frame: At 1 month
Descriptive analysis of pathogens responsible for severe infectious keratitis in Champagne-Ardenne
Time frame: At 1 month
• Costs of diagnostic methods (conventional and FilmArray) and management (cost of the average length of stay in ophthalmology at the Reims University Hospital for severe infectious keratitis)
Time frame: At 1 month
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