Clinical trial NCT02850653: Targeted PCR and Acute Endophthalmitis
Official title: Contribution of Fast Molecular Bacterial Identification by Real-time PCR in Managing of Postoperative Acute Endophthalmitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Endophthalmitis Post-operative
Keywords: Acute Endophthalmitis.
PCR
Ocular sampling
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endophthalmitis is a serious eye infection of exogenous origin (post-operational, post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic emergency.

Each patient suffering from endophthalmitis must have immediately an ocular sampling, an intra ocular injection of antibiotics and a systemic antibiotic cover.

The etiological treatment will be adapted according to the infectious agent.

Detailed description: The main goal of this prospective multi-centre trial is to improve the sensitivity and rapidity of the infectious agent's identification involved in endophthalmitis cases, particularly virulent species (like Staphylococcus aureus, Streptococcus pneumoniae...) from ocular samples with the help of real-time PCR.

This will help the ophthalmologist to be more efficient in accordance with the kind of the bacteria.

Data will also enable to compare both PCR techniques used in this study. The secondary goal of the prospective study is to characterize the resistance of bacterial's species found during acute endophthalmitis with the antibiogram and by the study of resistance genes, to enable to correlate the resistance in vitro with the therapeutic response in vivo and get precious epidemiological data to adapt prophylactic antibiotic.

Eligibility criteria: Inclusion Criteria:

* Subjects affiliated to the social security system
* Signed informed consent documentation
* Patients over 18 years
* Male or female person
* Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis, or within the context of a scheduled surgery with sampling of aqueous humour.
* Has given his or her consent, having been provided with detailed informations regarding to intraocular sampling.

Exclusion Criteria:

* antibiotherapy via intravenous (\< 8 days) for patients NON suffering from endophthalmitis (control group)
* Patient's participation to the study refused
* Patients under 18 years
* Patients adults under guardianship or curatorship, or unable to express his/her consent.
* Pregnant women
* Breastfeeding women
* Person deprived of liberty

Primary outcomes:
measure: Visual acuteness
timeFrame: 2 minutes
measure: Intraocular pressure
timeFrame: 5 minutes
measure: Biomicroscopic exam with the slit lamp
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: UniversityHospitalGrenoble
Study officials:
affiliation: Grenoble Hospital University
name: Christophe Chiquet, Doctor
role: PRINCIPAL_INVESTIGATOR
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