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NCT Number: NCT05888987

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

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.

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Key information

Conditions

Infectious Keratitis Corneal Infection Microbial Keratitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCR multiplex by FilmArray

Biological

PCR multiplex by FilmArray system on corneal swabbing sample

Primary outcomes

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

    Time frame: At 2 weeks

Secondary outcomes

  1. Duration of hospitalization

    Time frame: At 1 month

  2. Best corrected visual acuity

    Time frame: At 12 months

  3. Modification of the initial antimicrobial treatment after detection of the etiological agent

    Time frame: At 1 month

  4. Descriptive analysis of pathogens responsible for severe infectious keratitis in Champagne-Ardenne

    Time frame: At 1 month

  5. • 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)

    Time frame: At 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre DENOYER

CONTACT

[email protected]

03 26 78 78 88 ext. 0033

Thomas Ferreira de Moura

CONTACT

[email protected]

03 26 78 78 88 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: ABCORFILM

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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