Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PCR multiplex by FilmArray.
- Who it may be relevant to
- Registry conditions: Infectious Keratitis, Microbial Keratitis, Corneal Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of a New Rapid Multiplex PCR System for the Microbiological Diagnosis of Severe Infectious Keratitis: Impact on Therapeutic Management (ABCORFILM Study)
Overview
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.
Detailed description
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.
Interventions
- Biological PCR multiplex by FilmArray
PCR multiplex by FilmArray system on corneal swabbing sample
Primary outcome measures
- Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen. [Time frame: At 2 weeks]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- Over 18 years old
- With social security affiliation
- Willing to participate this study
- Hospitalized in our department for severe infectious keratitis
Non-inclusion criteria:
- Any prior (48 hours) or concomitant treatment with local or systemic antibiotherapy at time of corneal scrapping and swabbing
- Patient not covered by the French Health Insurance
- Unable to give informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
France · 1 center
- Damien JOLLY — Reims
Identifiers
NCT: NCT05888987 · PA23064