Infectious KeratitisABCORFILMNCT05888987
Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection
An observational study of Infectious Keratitis and Microbial Keratitis, run by CHU de Reims at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Keratitis, Microbial Keratitis, Corneal Infection
- What is being tested?
- PCR multiplex by FilmArray
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2023to 7 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Alexandre DENOYER, 03 26 78 78 88 ext. 0033, adenoyer@chu-reims.fr
Thomas Ferreira de Moura, 03 26 78 78 88 ext. 0033, tferreira-de-moura@chu-reims.fr
About this study
Official title: 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.
Read the 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
- Being tested
- PCR multiplex by FilmArray
- Keywords
- Severe infectious keratitis, Infectious keratitis, Microbial keratitis, Corneal infection, FilmArray, Multiplex PCR system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR multiplex by FilmArrayBiological
PCR multiplex by FilmArray system on corneal swabbing sample
| Study group | Role | What they receive |
|---|---|---|
| Before | Not described | |
| After | Not described Receives: Biological: PCR multiplex by FilmArray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen.
Measured: At 2 weeks
Secondary outcomes (5)
Duration of hospitalization
Measured: At 1 month
Best corrected visual acuity
Measured: At 12 months
Modification of the initial antimicrobial treatment after detection of the etiological agent
Measured: At 1 month
Descriptive analysis of pathogens responsible for severe infectious keratitis in Champagne-Ardenne
Measured: 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)
Measured: At 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start7 Jul 2023
- Primary completion7 Jan 2027 (estimated)
- Study completion7 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious KeratitisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888987
- Sponsor's protocol ID
- PA23064
- Acronym
- ABCORFILM
- Status last verified
- Sep 2024
- First submitted
- 25 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a New Rapid Multiplex PCR System for the Microbiological Diagnosis of Severe Infectious Keratitis: Impact on Therapeutic Management (ABCORFILM Study)
- ClinicalTrials.gov ID
- NCT05888987
- Acronym / sponsor ID
- ABCORFILM / PA23064
- Conditions
- Infectious Keratitis, Microbial Keratitis, Corneal Infection
- Keywords
- Severe infectious keratitis, Infectious keratitis, Microbial keratitis, Corneal infection, FilmArray, Multiplex PCR system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 7 Aug 2027 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before | – | – |
| After | – | Biological: PCR multiplex by FilmArray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR multiplex by FilmArrayPCR multiplex by FilmArray system on corneal swabbing sample | Biological | After |
Primary outcome
Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen.
Time frame: At 2 weeks
5 secondary outcomes
Duration of hospitalization
Time frame: At 1 month
Best corrected visual acuity
Time frame: At 12 months
Modification of the initial antimicrobial treatment after detection of the etiological agent
Time frame: At 1 month
Descriptive analysis of pathogens responsible for severe infectious keratitis in Champagne-Ardenne
Time frame: 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)
Time frame: At 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Infectious Keratitis
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Recruiting
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Bacterial Keratitis, Recalcitrant Infectious Keratitis
Active, not recruitingPhase 3
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Bacterial Keratitis
Not yet recruitingPhase 3
RB-PDT for Fusarium Keratitis: The LUMIERE Study
Fusarium Keratitis
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Keratitis and Microbial Keratitis, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre DENOYER (03 26 78 78 88 ext. 0033, adenoyer@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen. (time frame: At 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.