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

NCT ID: NCT05888987

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2027-08-07

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.

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.

Conditions

Infectious Keratitis; Microbial Keratitis; Corneal Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Before

No interventions assigned to this group

After

PCR multiplex by FilmArray

Intervention Type: BIOLOGICAL

PCR multiplex by FilmArray system on corneal swabbing sample

Interventions

PCR multiplex by FilmArray

PCR multiplex by FilmArray system on corneal swabbing sample

Intervention Type: BIOLOGICAL

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Damien JOLLY

Reims, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Alexandre DENOYER

Role: CONTACT

adenoyer@chu-reims.fr

03 26 78 78 88 ext. 0033

Thomas Ferreira de Moura

Role: CONTACT

tferreira-de-moura@chu-reims.fr

03 26 78 78 88 ext. 0033

Facility Contacts

Alexandre DENOYER

Role: primary

adenoyer@chu-reims.fr

03 26 78 78 88 ext. 0033

Thomas Ferreira de Moura

Role: backup

tferreira-de-moura@chu-reims.fr

03 26 78 78 88 ext. 0033

Other Identifiers

PA23064

Identifier Type: -

Identifier Source: org_study_id