Infective Endocarditis (IE)ENDOCNCT02816307
Etiology of Endocarditis in Negative Blood Cultures
A study testing blood samples in people with Infective Endocarditis (IE), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Infective endocarditis remains a serious disease that requires fast and specialized support in 2012. However, 24% of endocarditis unanswered etiology. The systematic use of new policy diagnosis, including (i) a systematic use of specific PCR techniques and (ii) the search for markers of inflammatory and tumoral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis (IE)
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,033 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 with endocarditis diagnostic kit prescribed
- Patient is more than 18 years old
- Patient who freely signed written informed consent.
- Patient affiliated to a health assurance
Who cannot join
- Minor patient (<18 years)
- Patient pregnant or breastfeeding
- Patient incapable or unable to consent
- Private patient of liberty or under court order
- Patient refusing to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Infective endocarditis remains a serious disease that requires fast and specialized support in 2012. However, 24% of endocarditis unanswered etiology. The systematic use of new policy diagnosis, including (i) a systematic use of specific PCR techniques and (ii) the search for markers of inflammatory and tumoral diseases, should increase the number of positive etiological diagnosis of culture-negative samples.
Secondly, because of the seriousness of the disease, the investigators were led to develop a new score: score for admission. This score, realized in less than 4 hours from the admission of the suspected patient with endocarditis, should allow for immediate probabilistic antibiotic treatment after completion of the diagnostic kit. The modified Duke score give its results in 4 to 7 days. With the score of admission thus diagnostic processes are accelerated and, where appropriate, empirical antibiotic therapy started.
Read more
Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological identification of endocarditis.
Secondary: Validate the "admission" score compared to the modified Duke score.
- Conditions
- Infective Endocarditis (IE)
- Being tested
- blood samples
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Infective endocarditis | Experimental | Not described Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with an etiological diagnosis of endocarditis
Measured: 6 years
Secondary outcomes (2)
The "admission" score
Measured: 1 day
the Duke score
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 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 Infective Endocarditis (IE)Studies 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
- 3,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- URIELLE DESALBRES, Study director, Assistance Publique Hopitaux De MarseilleJEAN PAUL CASALTA, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816307
- Sponsor's protocol ID
- 2012-39
- Other IDs
- 2012-A01549-34
- Acronym
- ENDOC
- Status last verified
- Apr 2023
- First submitted
- 21 Jun 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- Etiology of Endocarditis in Negative Blood Cultures
- ClinicalTrials.gov ID
- NCT02816307
- Acronym / sponsor ID
- ENDOC / 2012-39
- Conditions
- Infective Endocarditis (IE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,033 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
- 28 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.
Infective endocarditis remains a serious disease that requires fast and specialized support in 2012. However, 24% of endocarditis unanswered etiology. The systematic use of new policy diagnosis, including (i) a systematic use of specific PCR techniques and (ii) the search for markers of inflammatory and tumoral diseases, should increase the number of positive etiological diagnosis of culture-negative samples.
Secondly, because of the seriousness of the disease, the investigators were led to develop a new score: score for admission. This score, realized in less than 4 hours from the admission of the suspected patient with endocarditis, should allow for immediate probabilistic antibiotic treatment after completion of the diagnostic kit. The modified Duke score give its results in 4 to 7 days. With the score of admission thus diagnostic processes are accelerated and, where appropriate, empirical antibiotic therapy started.
Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological identification of endocarditis.
Secondary: Validate the "admission" score compared to the modified Duke score.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infective endocarditis | Experimental | Other: blood samples |
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 with endocarditis diagnostic kit prescribed
- Patient is more than 18 years old
- Patient who freely signed written informed consent.
- Patient affiliated to a health assurance
Key exclusion criteria (5 listed)
- Minor patient (<18 years)
- Patient pregnant or breastfeeding
- Patient incapable or unable to consent
- Private patient of liberty or under court order
- Patient refusing to participate in the research
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 samples | Other | Infective endocarditis |
Primary outcome
The percentage of patients with an etiological diagnosis of endocarditis
Time frame: 6 years
2 secondary outcomes
The "admission" score
Time frame: 1 day
the Duke score
Time frame: 1day
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: No
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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.
URIELLE DESALBRES study director
Assistance Publique Hopitaux De Marseille
JEAN PAUL CASALTA principal investigator
Assistance Publique Hopitaux 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 samples in people with Infective Endocarditis (IE), 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 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: 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?
The percentage of patients with an etiological diagnosis of endocarditis (time frame: 6 years). 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.