New method for diagnosing severe corneal infections
Use of a New Rapid Multiplex PCR System for the Microbiological Diagnosis of Severe Infectious Keratitis: Impact on Therapeutic Management (ABCORFILM Study)
This study is testing a new fast testing method for severe eye infections to see if it can quickly identify the cause better than standard tests, helping patients get the right treatment sooner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Trial ID | NCT05888987 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new PCR-based diagnostic method for severe infectious keratitis, a condition that can lead to blindness and requires immediate hospitalization. It involves two groups of patients: one group receiving standard diagnostic methods and another group undergoing rapid multiplex PCR testing using FilmArray systems. The goal is to compare the effectiveness of this new approach against conventional methods in identifying pathogens quickly, thereby facilitating timely treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are hospitalized for severe infectious keratitis.
Not a fit: Patients who have received any local or systemic antibiotic treatment within 48 hours prior to corneal sampling may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly reduce the time to diagnosis and improve treatment outcomes for patients with severe corneal infections.
How similar studies have performed: Other studies using rapid multiplex PCR for infectious diseases have shown promising results, suggesting potential success for this novel application in ophthalmology.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Reims
- Damien JOLLY — Reims, France (Recruiting)
Study contacts
- Study coordinator: Alexandre DENOYER
- Email: adenoyer@chu-reims.fr
- Phone: 03 26 78 78 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.