ICODIA: Complex Ocular Infection, Optimization of Microbiological Diagnosis

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05432336
Collaborator
(none)
149
1
18
8.3

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: NGS for endohtalmitis / Multiplex PCR for keratitis

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 Design

Study Type:
Observational
Anticipated Enrollment :
149 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Complex Ocular Infection, Optimization of Microbiological Diagnosis
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Complex ocular infections (COI)

All patients with an COI (endophtalmitis or hospitalized keratitis)

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
Other Names:
  • Bundle of intervervention to optimizing diagnosis of ocular complex infections
  • Outcome Measures

    Primary Outcome Measures

    1. Positivity rates of COI samples according to the new protocol [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) 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

    Secondary Outcome Measures

    1. Microbiological diagnosis of the infection [At the end of the follow up: 18 months]

      Analysis of a prospective cohort of COI

    2. Time to microbiological diagnosis according to the different technic [At the end of the follow up: 18 months]

      Analysis of a prospective cohort of COI

    3. Accuracy of the different technics according to the gold standard (microbiological culture) [At the end of the follow up: 18 months]

      Analysis of a prospective cohort of COI

    4. Visual acuity [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.

    5. Cure rate [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.

    6. Modification or not of the anti-infectious treatment [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    • Patient affiliated with a social security scheme (excluding AME)

    Exclusion Criteria:
    • Patient under guardianship or curatorship

    • Pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Equipe mobile d'infectiologie, Cochin hospital Paris IDF France 75014

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Etienne CANOUI, MD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05432336
    Other Study ID Numbers:
    • APHP220259
    • 2021-A02587-34
    First Posted:
    Jun 27, 2022
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 27, 2022