Microbiological Diagnosis of Infectious Uveitis to Pathogenic Fastidious Germs

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.

Study Overview

• Status: Completed
• Conditions: Uveitis
• Intervention / Treatment: Other: Blood sampling

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.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 ) .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Uveitis; Patient with a prescription of a microbiologic diagnostic of uveitis	Other: Blood sampling; Detection of bacteria will be performed on a blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with an etiological diagnosis of Uveitis	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of fastidious pathogenic germs detected	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2013
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: 2012-41; 2012-A01563-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED