Complex Ocular Infection, Optimization of Microbiological Diagnosis

Keratitis Clinical Trial

— ICODIA  

Official title:

Complex Ocular Infection, Optimization of Microbiological Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05432336
• Other study ID #: APHP220259
• Secondary ID: 2021-A02587-34
• Status: Recruiting
• Start date: November 21, 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Etienne CANOUI, MD
• Phone: 0033158414267
• Email: etienne.canoui[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 149
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endophthalmitis
• Eye Infections
• Keratitis

Intervention

Diagnostic Test:
• NGS for endohtalmitis / Multiplex PCR for keratitis
For endophtalmitis : optimizing culture and NGS will be realized For keratitis: Multiplex PCR will be added on ocular samples

Locations

Country	Name	City	State
France	Equipe mobile d'infectiologie, Cochin hospital	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positivity rates of COI samples according to the new protocol	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) 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	Microbiological diagnosis of the infection	Analysis of a prospective cohort of COI	At the end of the follow up: 18 months
Secondary	Time to microbiological diagnosis according to the different technic	Analysis of a prospective cohort of COI	At the end of the follow up: 18 months
Secondary	Accuracy of the different technics according to the gold standard (microbiological culture)	Analysis of a prospective cohort of COI	At the end of the follow up: 18 months
Secondary	Visual acuity	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
Secondary	Cure rate	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
Secondary	Modification or not of the anti-infectious treatment	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