ABCORFILM: Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection

Sponsor

CHU de Reims (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05888987

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infectious Keratitis Microbial Keratitis Corneal Infection	Biological: PCR multiplex by FilmArray

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

46 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Before
After	Biological: PCR multiplex by FilmArray PCR multiplex by FilmArray system on corneal swabbing sample

Arm

Intervention/Treatment

Before

After

Biological: PCR multiplex by FilmArray

PCR multiplex by FilmArray system on corneal swabbing sample

Outcome Measures

Primary Outcome Measures

Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen. [At 2 weeks]

Secondary Outcome Measures

Duration of hospitalization [At 1 month]
Best corrected visual acuity [At 12 months]
Modification of the initial antimicrobial treatment after detection of the etiological agent [At 1 month]
Descriptive analysis of pathogens responsible for severe infectious keratitis in Champagne-Ardenne [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) [At 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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