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

Infectious Keratitis Clinical Trial

— ABCORFILM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888987
• Other study ID #: PA23064
• Status: Recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: February 7, 2026
• Est. primary completion date: July 7, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Keratitis
• Keratitis

Intervention

Biological:
• PCR multiplex by FilmArray
PCR multiplex by FilmArray system on corneal swabbing sample

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen.		At 2 weeks
Secondary	Duration of hospitalization		At 1 month
Secondary	Best corrected visual acuity		At 12 months
Secondary	Modification of the initial antimicrobial treatment after detection of the etiological agent		At 1 month
Secondary	Descriptive analysis of pathogens responsible for severe infectious keratitis in Champagne-Ardenne		At 1 month
Secondary	• 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