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

NCT05888987 | Recruiting

• 1 other identifier: PA23064
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Keratitis; Microbial Keratitis; Corneal Infection

Keywords

Severe infectious keratitis; Infectious keratitis; Microbial keratitis; Corneal infection; FilmArray; Multiplex PCR system

Outcome Measures

Primary Outcomes (1)

• Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen.

  At 2 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Before

After

Biological: PCR multiplex by FilmArray

Interventions

PCR multiplex by FilmArray BIOLOGICAL

PCR multiplex by FilmArray system on corneal swabbing sample

After

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

Central Study Contacts

Alexandre DENOYER

CONTACT

03 26 78 78 88; adenoyer@chu-reims.fr

Thomas Ferreira de Moura

CONTACT

03 26 78 78 88; tferreira-de-moura@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: July 7, 2023
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): August 7, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)