Infective EndocarditisNCT03979261
Predisposition to Infectious Endocarditis
An observational study of Infective Endocarditis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
To evaluate the gender-related elements, a first step will be to analyze the impact of sex ratio on different parameters such as age in endocarditis and the type of underlying valvulopathy and other associated comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- evolution of sex ratio according to age
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 1 Jul 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patient with valvulopathy or infective endocarditis requiring cardiac surgery as part of routine care.
Who may be able to join
- Patient with infectious endocarditis
- Patient with valvulopathy or infective endocarditis requiring cardiac surgery as part of routine care.
- Major patient
- Patient informed of the study and having expressed no opposition to participate in the study.
- Patient affiliated to a social security scheme.
Who cannot join
- Minor patient
- Pregnant or nursing patient.
- Patient deprived of liberty or under judicial decision.
- Major patient under tutorship or curatorship.
- Patient not agreeing to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratoires d'immunologie et d'infectiologie
Marseille, Cedex 5, 13354
Didier RAOULT, didier.raoult@ap-hm.fr
About this study
Official title: Gender Study on Predisposition to Infectious Endocarditis
To evaluate the gender-related elements, a first step will be to analyze the impact of sex ratio on different parameters such as age in endocarditis and the type of underlying valvulopathy and other associated comorbidities.
Read the detailed description
Numerous epidemiological studies have made it possible to highlight the impact of the genus on the occurrence and natural evolution of numerous valvulopathies. Severe valve leakage occurs more frequently in men. This association is also observed in patients with aortic bicuspid infarction where infective endocarditis (IE) is 3 times more common in men with a sex ratio of 9 to 2 to 1. Male sex is also a risk factor of AEs in the admission score used in initial patient management used to stratify the risk of AE and start probabilistic antibiotic therapy. Several hypotheses were evoked and none made it possible to understand the impact of sex on the risk of IE. The transcriptome study of IE patients revealed 2 potential biomarkers. S100A11 (S100 calcium binding protein A11) is a diagnostic marker and AQP9 (Aquaporin 9 gene) a poor prognostic factor in patients with AE. Coxiella burnetii AE is more common and more severe in humans. A study in the C57 / BL6 mouse demonstrated the role of 17 beta-estradiol in decreasing bacterial load and granuloma formation in female mice. The hypothesis formulated is that sex hormones play a role in the natural history of IS. This hypothesis was confirmed at the transcriptome level in mice and allowed to identify transcriptomic signatures according to sex; male mice with a more marked inflammatory response to C. burnetii. In order to evaluate the gender-related elements, an initial work will be to analyze the impact of sex ratio on different parameters such as age in endocarditis and the type of underlying valvulopathy and other associated comorbidities.
The second part of the project will study (i) the transcriptional profile of the native valves removed in patients with endocarditis-free valvulopathy in male and female subjects (ii) the transcriptional profile of native valves removed during endocarditis in matching sex underlying valvulopathy and microorganism. This will evaluate a possible difference in susceptibility to endocardial fixation. (iii) the transcriptional profile of PBMCs (circulating mononuclear cells) in this same patient, which will make it possible to study the transcriptional profile of the circulating genes and to evaluate the possible difference in predisposition to endocardial fixation.
Finally, the third part will focus on the histological analysis of the valves collected to study the differences between man and woman (local inflammatory reaction, cell type found).
- Conditions
- Infective Endocarditis
- Being tested
- evolution of sex ratio according to age
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evolution of sex ratio according to ageDiagnostic test
Histological study of the collected valves to study the differences according to the sex of the inflammatory reaction and the cellular type found.
| Study group | Role | What they receive |
|---|---|---|
| sex ratio evaluation | Valvular surgery is performed in 30-40% of cases. The Cardiology and Cardiac Surgery De la Timone services 1000 patients as part of their valvulopathy and 450 benefit from cardiac surgery. On the other hand, transcriptomic analysis by microarray will only be done on 40 patients because the analysis costs 150 € / patients. Receives: Diagnostic Test: evolution of sex ratio according to age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of sex ratio as a function of age and underlying pathologies (comorbidities and valvulopathies)
Measured: 36 months
Secondary outcomes (1)
transcriptional profile by microarray
rate of indigenous valves removed in patients with valvulopathy without endocarditis by gender
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, AP HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979261
- Sponsor's protocol ID
- 2018-58
- Other IDs
- 2018-A02503-52
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Study on Predisposition to Infectious Endocarditis
- ClinicalTrials.gov ID
- NCT03979261
- Acronym / sponsor ID
- 2018-58
- Conditions
- Infective Endocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 7 Jun 2019 (actual)
- 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.
To evaluate the gender-related elements, a first step will be to analyze the impact of sex ratio on different parameters such as age in endocarditis and the type of underlying valvulopathy and other associated comorbidities.
Detailed description
Numerous epidemiological studies have made it possible to highlight the impact of the genus on the occurrence and natural evolution of numerous valvulopathies. Severe valve leakage occurs more frequently in men. This association is also observed in patients with aortic bicuspid infarction where infective endocarditis (IE) is 3 times more common in men with a sex ratio of 9 to 2 to 1. Male sex is also a risk factor of AEs in the admission score used in initial patient management used to stratify the risk of AE and start probabilistic antibiotic therapy. Several hypotheses were evoked and none made it possible to understand the impact of sex on the risk of IE. The transcriptome study of IE patients revealed 2 potential biomarkers. S100A11 (S100 calcium binding protein A11) is a diagnostic marker and AQP9 (Aquaporin 9 gene) a poor prognostic factor in patients with AE. Coxiella burnetii AE is more common and more severe in humans. A study in the C57 / BL6 mouse demonstrated the role of 17 beta-estradiol in decreasing bacterial load and granuloma formation in female mice. The hypothesis formulated is that sex hormones play a role in the natural history of IS. This hypothesis was confirmed at the transcriptome level in mice and allowed to identify transcriptomic signatures according to sex; male mice with a more marked inflammatory response to C. burnetii. In order to evaluate the gender-related elements, an initial work will be to analyze the impact of sex ratio on different parameters such as age in endocarditis and the type of underlying valvulopathy and other associated comorbidities.
The second part of the project will study (i) the transcriptional profile of the native valves removed in patients with endocarditis-free valvulopathy in male and female subjects (ii) the transcriptional profile of native valves removed during endocarditis in matching sex underlying valvulopathy and microorganism. This will evaluate a possible difference in susceptibility to endocardial fixation. (iii) the transcriptional profile of PBMCs (circulating mononuclear cells) in this same patient, which will make it possible to study the transcriptional profile of the circulating genes and to evaluate the possible difference in predisposition to endocardial fixation.
Finally, the third part will focus on the histological analysis of the valves collected to study the differences between man and woman (local inflammatory reaction, cell type found).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sex ratio evaluation | – | Diagnostic Test: evolution of sex ratio according to ageValvular surgery is performed in 30-40% of cases. The Cardiology and Cardiac Surgery De la Timone services 1000 patients as part of their valvulopathy and 450 benefit from cardiac surgery. On the other hand, transcriptomic analysis by microarray will only be done on 40 patients because the analysis costs 150 € / patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with valvulopathy or infective endocarditis requiring cardiac surgery as part of routine care.
Key inclusion criteria (5 listed)
- Patient with infectious endocarditis
- Patient with valvulopathy or infective endocarditis requiring cardiac surgery as part of routine care.
- Major patient
- Patient informed of the study and having expressed no opposition to participate in the study.
- Patient affiliated to a social security scheme.
Key exclusion criteria (5 listed)
- Minor patient
- Pregnant or nursing patient.
- Patient deprived of liberty or under judicial decision.
- Major patient under tutorship or curatorship.
- Patient not agreeing to participate
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 |
|---|---|---|
| evolution of sex ratio according to ageHistological study of the collected valves to study the differences according to the sex of the inflammatory reaction and the cellular type found. | Diagnostic test | sex ratio evaluation |
Primary outcome
Evolution of sex ratio as a function of age and underlying pathologies (comorbidities and valvulopathies)
Time frame: 36 months
1 secondary outcome
transcriptional profile by microarray
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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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.
Jean-Olivier ARNAUD study director
AP HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis, 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier RAOULT, IP (04 13 73 20 5, didier.raoult@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of sex ratio as a function of age and underlying pathologies (comorbidities and valvulopathies) (time frame: 36 months). 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 14 Jun 2019.