UveitisNCT02819206
Microbiological Diagnosis of Infectious Uveitis to Pathogenic Fastidious Germs
A study testing Blood sampling in people with Uveitis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2013to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ) .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Uveitis
- Being tested
- Blood sampling
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Detection of bacteria will be performed on a blood sample
| Study group | Role | What they receive |
|---|---|---|
| Uveitis | Other | Patient with a prescription of a microbiologic diagnostic of uveitis Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with an etiological diagnosis of Uveitis
Measured: 1 day
Secondary outcomes (1)
Number of fastidious pathogenic germs detected
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start7 Jun 2013
- Primary completion6 Mar 2019
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance publique hôpitaux de marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819206
- Sponsor's protocol ID
- 2012-41
- Other IDs
- 2012-A01563-40
- Status last verified
- Apr 2023
- First submitted
- 28 Jun 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Diagnosis of Infectious Uveitis to Pathogenic Fastidious Germs
- ClinicalTrials.gov ID
- NCT02819206
- Acronym / sponsor ID
- 2012-41
- Conditions
- Uveitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 7 Jun 2013 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uveitis | Other | Other: Blood samplingPatient with a prescription of a microbiologic diagnostic of uveitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingDetection of bacteria will be performed on a blood sample | Other | Uveitis |
Primary outcome
Percentage of patients with an etiological diagnosis of Uveitis
Time frame: 1 day
1 secondary outcome
Number of fastidious pathogenic germs detected
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine GEINDRE study director
Assistance publique hôpitaux de marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Uveitis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with an etiological diagnosis of Uveitis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.