Complex Ocular Infection, Optimization of Microbiological Diagnosis (ICODIA)
The purpose of this study is to evaluate the impact of different technique to optimize the microbiological diagnosis of the COI.
- Metagenomic for the endophtalmitis
- Multiplex polymerase chain reaction for corneal abscesses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Microbiological diagnosis of complex ocular infection (COI) (i.e: endophtalmitis and corneal abscess) is a current challenge. Indeed, endophtalmitis are often germ-free because a lack of microbiological diagnosis due to small volume to analyze and a complex site to attain. The microbiological etiologies of corneal abscesses are more frequently identified.
Since few years, new molecular tools are developed in infectious diseases to optimizing the microbiological diagnosis. The investigators implemented these techniques in our hospital to optimize the microbiological diagnosis of complex ocular infection (COI). Thus, endophtalmitis benefit, when the volume of the ocular sample is sufficient, of molecular techniques (16s PCR and metagenomic shotgun). Corneal abscesses could shortly benefit of multiplex PCR in order to reduce the time to diagnosis.
The impact and accuracy of these techniques is unknown.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Etienne CANOUI, MD
- Phone Number: 0033158414267
- Email: etienne.canoui@aphp.fr
Study Contact Backup
- Name: Marie Benhammani-Godard
- Phone Number: 0033158411190
- Email: marie.godard@aphp.fr
Study Locations
-
-
IDF
-
Paris, IDF, France, 75014
- Recruiting
- Equipe mobile d'infectiologie, Cochin hospital
-
Contact:
- Etienne CANOUI, MD
- Phone Number: 0033158414267
- Email: etienne.canoui@aphp.fr
-
Contact:
- Marie Benhammani-Godard
- Phone Number: 0033158411190
- Email: marie.godard@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patient
Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis:
- Corneal abscess requiring hospitalization
- Any suspicion of endogenous or exogenous endophthalmitis.
- Patient not opposed to participating in the research
Exclusion Criteria:
- Patient under guardianship or curatorship
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Complex ocular infections (COI)
All patients with an COI (endophtalmitis or hospitalized keratitis)
|
For endophtalmitis : optimizing culture and NGS will be realized For keratitis: Multiplex PCR will be added on ocular samples
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positivity rates of COI samples according to the new protocol
Time Frame: 2 weeks after taking samples
|
Before/after type comparison. Comparison of the positivity rates of COI samples according to the new protocol: (i) for endophthalmitis performing a vitreous puncture (PV) or an anterior chamber puncture (PCA), or corneal scraping, optimized with modification of microbiological techniques (culture on enriched medium alone associated with shotgun metagenomics), (ii) for severe corneal abscesses, addition to standard microbiological techniques of molecular biology tests (multiplex PCR and / or metagenomics). An COI will be considered with a positive microbiological diagnosis after multidisciplinary concertation considering the different results |
2 weeks after taking samples
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiological diagnosis of the infection
Time Frame: At the end of the follow up: 18 months
|
Analysis of a prospective cohort of COI
|
At the end of the follow up: 18 months
|
|
Time to microbiological diagnosis according to the different technic
Time Frame: At the end of the follow up: 18 months
|
Analysis of a prospective cohort of COI
|
At the end of the follow up: 18 months
|
|
Accuracy of the different technics according to the gold standard (microbiological culture)
Time Frame: At the end of the follow up: 18 months
|
Analysis of a prospective cohort of COI
|
At the end of the follow up: 18 months
|
|
Visual acuity
Time Frame: At the end of the follow up: 18 months
|
Evaluation of visual acuity at the end of treatment and the cure rate.
The investigators hypothesized that the improvement of the microbiological diagnosis allows an improvement of the therapeutic management and thus of the visual outcome.
|
At the end of the follow up: 18 months
|
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Cure rate
Time Frame: At the end of the follow up: 18 months
|
Evaluation of visual acuity at the end of treatment and the cure rate.
The investigators hypothesized that the improvement of the microbiological diagnosis allows an improvement of the therapeutic management and thus of the visual outcome.
|
At the end of the follow up: 18 months
|
|
Modification or not of the anti-infectious treatment
Time Frame: At the end of the follow up: 18 months
|
Analysis of the impact of microbiological diagnosis on the choice of anti-infectious molecules.. The investigators hypothesized that the improvement of the microbiological diagnosis and the implementation of the COI management bundle will induce a modification of the prescription of anti-infectious molecules. The investigators will realize a qualitative and quantitative analysis of prescribed anti-infective molecules |
At the end of the follow up: 18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Etienne CANOUI, MD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP220259
- 2021-A02587-34 (Other Identifier: France : ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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