Targeted PCR and Acute Endophthalmitis

Not Applicable

• Conditions: Acute Endophthalmitis Post-operative
• Interventions: Biological: Sampling of aqueous humour

• Registration Number: NCT02850653
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2007-11
• Status Verified: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Posted: 2016-08-01
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy control patient	Sampling of aqueous humour	Patients hospitalized in the context of a scheduled surgery with sampling of aqueous humour.
Endophthalmitis sufferers	Sampling of aqueous humour	Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis.

Primary Outcome Measures

Name	Time	Method
Visual acuteness	2 minutes	Clinical follow-up of patients
Intraocular pressure	5 minutes	Clinical follow-up of patients
Biomicroscopic exam with the slit lamp	3 minutes	State of anterior and posterior segment (back of the eye)

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 La Tronche, France