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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02819206
Other study ID # 2012-41
Secondary ID 2012-A01563-40
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2013
Est. completion date October 26, 2022

Study information

Verified date April 2023
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date October 26, 2022
Est. primary completion date March 6, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sampling
Detection of bacteria will be performed on a blood sample

Locations

Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with an etiological diagnosis of Uveitis 1 day
Secondary Number of fastidious pathogenic germs detected 1 day
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