EndophthalmitisICODIANCT05432336
Complex Ocular Infection, Optimization of Microbiological Diagnosis
An observational study of Endophthalmitis and Keratitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis, Keratitis
- What is being tested?
- NGS for endohtalmitis / Multiplex PCR for keratitis
- How many people
- 153 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2023to Jan 2026
- 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: Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis
Who may be able to join
- 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
Who cannot join
- Patient under guardianship or curatorship
- Pregnant women
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
Equipe mobile d'infectiologie, Cochin hospital
Paris, IDF, 75014
Etienne CANOUI, MD, 0033158414267, etienne.canoui@aphp.fr
Marie BENHAMMANI-GODARD, 0033158411190, marie.godard@aphp.fr
About this study
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
Read the 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.
- Conditions
- Endophthalmitis, Keratitis
- Being tested
- NGS for endohtalmitis / Multiplex PCR for keratitis
- Keywords
- Endogenous Endophtalmitis, exogenous endophtalmitis, keratitis, PCR, NGS
- Medical subject headings
- Endophthalmitis, Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS for endohtalmitis / Multiplex PCR for keratitisDiagnostic test
Also called Bundle of intervervention to optimizing diagnosis of ocular complex infections
For endophtalmitis : optimizing culture and NGS will be realized
For keratitis: Multiplex PCR will be added on ocular samples
| Study group | Role | What they receive |
|---|---|---|
| Complex ocular infections (COI) | All patients with an COI (endophtalmitis or hospitalized keratitis) Receives: Diagnostic Test: NGS for endohtalmitis / Multiplex PCR for keratitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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), 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
Measured: 2 weeks after taking samples
Secondary outcomes (6)
Microbiological diagnosis of the infection
Analysis of a prospective cohort of COI
Measured: At the end of the follow up: 18 months
Time to microbiological diagnosis according to the different technic
Analysis of a prospective cohort of COI
Measured: At the end of the follow up: 18 months
Accuracy of the different technics according to the gold standard (microbiological culture)
Analysis of a prospective cohort of COI
Measured: At the end of the follow up: 18 months
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.
Measured: At the end of the follow up: 18 months
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.
Measured: At the end of the follow up: 18 months
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
Measured: At the end of the follow up: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start21 Nov 2023
- Primary completion17 Jul 2025
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Etienne CANOUI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432336
- Sponsor's protocol ID
- APHP220259
- Other IDs
- 2021-A02587-34
- Acronym
- ICODIA
- Status last verified
- Sep 2025
- First submitted
- 12 May 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Ocular Infection, Optimization of Microbiological Diagnosis
- ClinicalTrials.gov ID
- NCT05432336
- Acronym / sponsor ID
- ICODIA / APHP220259
- Conditions
- Endophthalmitis, Keratitis
- Keywords
- Endogenous Endophtalmitis, exogenous endophtalmitis, keratitis, PCR, NGS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 27 Jun 2022 (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.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complex ocular infections (COI) | – | Diagnostic Test: NGS for endohtalmitis / Multiplex PCR for keratitisAll patients with an COI (endophtalmitis or hospitalized keratitis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis
Key inclusion criteria (5 listed)
- Adult patient
- Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis:
- Patient not opposed to participating in the research
Key exclusion criteria (2 listed)
- Patient under guardianship or curatorship
- Pregnant women
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 |
|---|---|---|
| NGS for endohtalmitis / Multiplex PCR for keratitisAlso: Bundle of intervervention to optimizing diagnosis of ocular complex infectionsFor endophtalmitis : optimizing culture and NGS will be realized For keratitis: Multiplex PCR will be added on ocular samples | Diagnostic test | Complex ocular infections (COI) |
Primary outcome
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
6 secondary outcomes
Microbiological diagnosis of the infection
Time frame: 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
Accuracy of the different technics according to the gold standard (microbiological culture)
Time frame: At the end of the follow up: 18 months
Visual acuity
Time frame: At the end of the follow up: 18 months
Cure rate
Time frame: 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
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Etienne CANOUI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Endophthalmitis and Keratitis, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 2 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 15 Sep 2025. 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 Etienne CANOUI, MD (0033158414267, etienne.canoui@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positivity rates of COI samples according to the new protocol (time frame: 2 weeks after taking samples). 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 15 Sep 2025.