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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infectious Keratitis; Microbial Keratitis; Corneal Infection
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 46

Contacts and Locations

• Study Contact: Name: Alexandre DENOYER; Phone Number: 0033 03 26 78 78 88; Email: adenoyer@chu-reims.fr
• Study Contact Backup: Name: Thomas Ferreira de Moura; Phone Number: 0033 03 26 78 78 88; Email: tferreira-de-moura@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Recruiting
    • Damien JOLLY
    • Contact: Alexandre DENOYER; Phone Number: 0033 03 26 78 78 88; Email: adenoyer@chu-reims.fr
    • Contact: Thomas Ferreira de Moura; Phone Number: 0033 03 26 78 78 88; Email: tferreira-de-moura@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated for a severe corneal abscess according to the Mackie classification (requiring hospitalization) at the Reims University Hospital between 05/01/2022 and 04/30/2023 ("before" phase) and between 01/ 05/2023 and 04/30/2024 ("after" phase).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen.	At 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): July 7, 2025
• Study Completion (Estimated): February 7, 2026

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: FilmArray; Microbial keratitis; Infectious keratitis; Severe infectious keratitis; Corneal infection; Multiplex PCR system
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Corneal Diseases; Infections; Communicable Diseases; Keratitis
• Other Study ID Numbers: PA23064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No