Health TrialsbyHealthPanel

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

ConditionsInfectious KeratitisMicrobial KeratitisCorneal Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCHU de Reims

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years old

With social security affiliation

Willing to participate this study

Hospitalized in our department for severe infectious keratitis

Disqualifiers

None

Trial 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).

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • PCR multiplex by FilmArray

    Biological/Vaccine

    PCR multiplex by FilmArray system on corneal swabbing sample

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Before0 interventions
Group B: After1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHU de Reims

Lead sponsor

Source ClinicalTrials.gov
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