Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05888987 |
Other study ID # |
PA23064 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 7, 2023 |
Est. completion date |
February 7, 2026 |
Study information
Verified date |
January 2024 |
Source |
CHU de Reims |
Contact |
Alexandre DENOYER |
Phone |
03 26 78 78 88 |
Email |
adenoyer[@]chu-reims.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
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.