Microbiological Diagnosis of Infectious Uveitis to Pathogenic Fastidious Germs
Primary Purpose
Uveitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Uveitis
Eligibility Criteria
Inclusion Criteria:
* Patient is more than 18 years old.
- Patient with a prescription of a microbiologic diagnostic of uveitis
- Patient who do not declined to have his medical records reviewed for research
- Patient with health insurance
Exclusion Criteria:
* Minor Patient ( age <18 years) (L. 1121-7 ) .
- Pregnant woman , parturient or nursing (L. 1121-5 ) .
- Patient major under guardianship (L. 1121-8 ) .
- Patient vital in emergency.
- Patient refusing to sign the informed consent form .
- Patient deprived of liberty under court order (L. 1121-6 ) .
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Uveitis
Arm Description
Patient with a prescription of a microbiologic diagnostic of uveitis
Outcomes
Primary Outcome Measures
Percentage of patients with an etiological diagnosis of Uveitis
Secondary Outcome Measures
Number of fastidious pathogenic germs detected
Full Information
NCT ID
NCT02819206
First Posted
June 28, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02819206
Brief Title
Microbiological Diagnosis of Infectious Uveitis to Pathogenic Fastidious Germs
Official Title
Microbiological Diagnosis of Infectious Uveitis to Pathogenic Fastidious Germs
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2013 (Actual)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our research project is to use a new microbiological diagnostic strategy of uveitis, allowing detection of the fastidious pathogens of infectious Uveitis who are not diagnosed by laboratory methods used in diagnostic routine. This new diagnostic strategy is to automatically detect the presence of a pathogen fastidious in cell culture using the same patient's serum to reveal a positive culture, based on the assumption that this serum contains antibodies specific pathogen tedious.
Finally, the main purpose of this study is to improve the etiological diagnosis of Uveitis by establishing a new diagnostic strategy.
Detailed Description
The Mediterranean Infection microbiology laboratory is the national Reference Laboratory for the diagnosis of infectious Uveitis. The essential problem of the Uveitis is the etiological diagnosis since currently in 60% of cases no etiological diagnosis is brought out despite the deployment of routine diagnostic tests. The prognosis of the Uveitis is generally good but 15% approximately of Uveitis are evolving on a chronic mode which decreased faster than the Visual acuity of the eye reached that can lead to blindness in bilateral cases of Uveitis. Different works of the literature identified a few pathogenic microorganisms, viruses and bacteria as being responsible for uveitis, including within the particular framework of the endophtalmies. Recent work allowed to highlight the place of fastidious bacteria (Bartonella spp., Tropheryma whipplei, Rickettsia spp., Coxiella burnetii, Borrelia spp.) in these Uveitis. Despite all his investigations, is estimated that 20-30% of Uveitis likely to be of infectious origin are not documented by the methods used in routine. Our research project is to use a new microbiological diagnostic strategy of uveitis, allowing detection of the fastidious pathogens of infectious Uveitis who are not diagnosed by laboratory methods used in diagnostic routine. This new diagnostic strategy is to automatically detect the presence of a pathogen fastidious in cell culture using the same patient's serum to reveal a positive culture, based on the assumption that this serum contains antibodies specific pathogen tedious.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uveitis
Arm Type
Other
Arm Description
Patient with a prescription of a microbiologic diagnostic of uveitis
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Detection of bacteria will be performed on a blood sample
Primary Outcome Measure Information:
Title
Percentage of patients with an etiological diagnosis of Uveitis
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of fastidious pathogenic germs detected
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
* Patient is more than 18 years old.
Patient with a prescription of a microbiologic diagnostic of uveitis
Patient who do not declined to have his medical records reviewed for research
Patient with health insurance
Exclusion Criteria:
* Minor Patient ( age <18 years) (L. 1121-7 ) .
Pregnant woman , parturient or nursing (L. 1121-5 ) .
Patient major under guardianship (L. 1121-8 ) .
Patient vital in emergency.
Patient refusing to sign the informed consent form .
Patient deprived of liberty under court order (L. 1121-6 ) .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GEINDRE
Organizational Affiliation
Assistance publique hôpitaux de marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Microbiological Diagnosis of Infectious Uveitis to Pathogenic Fastidious Germs
We'll reach out to this number within 24 hrs