Clinical trial NCT05432336: Complex Ocular Infection, Optimization of Microbiological Diagnosis
Official title: Complex Ocular Infection, Optimization of Microbiological Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endophthalmitis
Keratitis
Keywords: Endogenous Endophtalmitis
exogenous endophtalmitis
keratitis
PCR
NGS
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positivity rates of COI samples according to the new protocol
timeFrame: 2 weeks after taking samples
Secondary outcomes:
measure: Microbiological diagnosis of the infection
timeFrame: At the end of the follow up: 18 months
measure: Time to microbiological diagnosis according to the different technic
timeFrame: At the end of the follow up: 18 months
measure: Accuracy of the different technics according to the gold standard (microbiological culture)
timeFrame: At the end of the follow up: 18 months
measure: Visual acuity
timeFrame: At the end of the follow up: 18 months
measure: Cure rate
timeFrame: At the end of the follow up: 18 months
measure: Modification or not of the anti-infectious treatment
timeFrame: At the end of the follow up: 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Equipe mobile d'infectiologie, Cochin hospital
state: IDF
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Etienne CANOUI, MD
role: PRINCIPAL_INVESTIGATOR
References: