Clinical trial

Use of a New Rapid Multiplex PCR System for the Microbiological Diagnosis of Severe Infectious Keratitis: Impact on Therapeutic Management (ABCORFILM Study)

Name
PA23064
Description
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.
Trial arms
Trial start
2023-07-07
Estimated PCD
2025-07-07
Trial end
2026-02-07
Status
Recruiting
Treatment
PCR multiplex by FilmArray
PCR multiplex by FilmArray system on corneal swabbing sample
Arms:
After
Size
46
Primary endpoint
Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen.
At 2 weeks
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}
Updated at
2024-01-19

1 organization

1 product

3 indications

Indication
Keratitis
Indication
eye infection