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Targeted PCR and Acute Endophthalmitis (Targeted PCR)

Primary Purpose

Acute Endophthalmitis Post-operative

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PCR : 16S ribosomal DNA and real-time targeted PCR
Sampling of aqueous humour
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Endophthalmitis Post-operative focused on measuring Acute Endophthalmitis., PCR, Ocular sampling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • UniversityHospitalGrenobleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Endophthalmitis sufferers

Healthy control patient

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual acuteness
Clinical follow-up of patients
Intraocular pressure
Clinical follow-up of patients
Biomicroscopic exam with the slit lamp
State of anterior and posterior segment (back of the eye)

Secondary Outcome Measures

Full Information

First Posted
July 11, 2016
Last Updated
July 29, 2016
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02850653
Brief Title
Targeted PCR and Acute Endophthalmitis
Acronym
Targeted PCR
Official Title
Contribution of Fast Molecular Bacterial Identification by Real-time PCR in Managing of Postoperative Acute Endophthalmitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Endophthalmitis Post-operative
Keywords
Acute Endophthalmitis., PCR, Ocular sampling

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endophthalmitis sufferers
Arm Type
Other
Arm Description
Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis.
Arm Title
Healthy control patient
Arm Type
Other
Arm Description
Patients hospitalized in the context of a scheduled surgery with sampling of aqueous humour.
Intervention Type
Biological
Intervention Name(s)
PCR : 16S ribosomal DNA and real-time targeted PCR
Intervention Type
Biological
Intervention Name(s)
Sampling of aqueous humour
Primary Outcome Measure Information:
Title
Visual acuteness
Description
Clinical follow-up of patients
Time Frame
2 minutes
Title
Intraocular pressure
Description
Clinical follow-up of patients
Time Frame
5 minutes
Title
Biomicroscopic exam with the slit lamp
Description
State of anterior and posterior segment (back of the eye)
Time Frame
3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Chiquet, Doctor
Phone
04 76 76 55 48
Email
CChiquet@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Max Maurin, Professor
Phone
04 76 76 54 79
Email
MMaurin@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Chiquet, Doctor
Organizational Affiliation
Grenoble Hospital University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversityHospitalGrenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Chiquet, Doctor
Phone
04 76 76 55 48
Email
CChiquet@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Max Maurin, Professor
Phone
04 76 76 54 79
Email
MMaurin@chu-grenoble.fr

12. IPD Sharing Statement

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Targeted PCR and Acute Endophthalmitis

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