NCT02819206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2022

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

5.7 years

First QC Date

June 28, 2016

Last Update Submit

April 20, 2023

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with an etiological diagnosis of Uveitis

    1 day

Secondary Outcomes (1)

  • Number of fastidious pathogenic germs detected

    1 day

Study Arms (1)

Uveitis

OTHER

Patient with a prescription of a microbiologic diagnostic of uveitis

Other: Blood sampling

Interventions

Blood samplingOTHER

Detection of bacteria will be performed on a blood sample

Uveitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \* 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

You may not qualify if:

  • \* 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 ) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Uveitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Catherine GEINDRE

    Assistance publique hôpitaux de marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

June 30, 2016

Study Start

June 7, 2013

Primary Completion

March 6, 2019

Study Completion

October 26, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

FR(1)