Targeted PCR and Acute Endophthalmitis (Targeted PCR)

Contribution of Fast Molecular Bacterial Identification by Real-time PCR in Managing of Postoperative Acute Endophthalmitis

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.

Study Overview

• Status: Unknown
• Conditions: Acute Endophthalmitis Post-operative
• Intervention / Treatment: Biological: PCR : 16S ribosomal DNA and real-time targeted PCR; Biological: Sampling of aqueous humour

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Tronche, France, 38700
    • Recruiting
    • UniversityHospitalGrenoble
    • Contact: Christophe Chiquet, Doctor; Phone Number: 04 76 76 55 48; Email: CChiquet@chu-grenoble.fr
    • Contact: Max Maurin, Professor; Phone Number: 04 76 76 54 79; Email: MMaurin@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Endophthalmitis sufferers; Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis.	Biological: PCR : 16S ribosomal DNA and real-time targeted PCR; Biological: Sampling of aqueous humour
Other: Healthy control patient; Patients hospitalized in the context of a scheduled surgery with sampling of aqueous humour.	Biological: PCR : 16S ribosomal DNA and real-time targeted PCR; Biological: Sampling of aqueous humour

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Christophe Chiquet, Doctor, Grenoble Hospital University

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Estimate): August 1, 2016
• Last Update Submitted That Met QC Criteria: July 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: PCR; Acute Endophthalmitis.; Ocular sampling
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Eye Diseases; Disease Attributes; Eye Infections; Acute Disease; Endophthalmitis
• Other Study ID Numbers: 38RC07.006