Targeted PCR and Acute Endophthalmitis

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Acute Endophthalmitis Post-operative

Treatments: Biological: Sampling of aqueous humour; Biological: PCR : 16S ribosomal DNA and real-time targeted PCR

Study type: Interventional

Funder types: Other

Identifiers

NCT02850653

38RC07.006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Endophthalmitis sufferers

Other group

Description:

Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis.

Treatment:

Biological: Sampling of aqueous humour

Biological: PCR : 16S ribosomal DNA and real-time targeted PCR

Healthy control patient

Other group

Description:

Patients hospitalized in the context of a scheduled surgery with sampling of aqueous humour.

Treatment:

Biological: Sampling of aqueous humour

Biological: PCR : 16S ribosomal DNA and real-time targeted PCR