Infective EndocarditisNCT00947817
Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism
A study testing ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test in people with Infective Endocarditis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Prospective study including all the consecutive patients admitted at the Department of Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched control subject will be included. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Apr 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All the patients presenting certain diagnosis of infectious endocardite according to the criteria of modified Duke
Who cannot join
- Age < 18 years
- Pregnancy and feeding
- Health not allowing to give the assent
- Innate abnormalities of the haemostasis
- More than a week before the inclu antibiothérapie adapted begun
Trial locations and contacts
1 site in 1 country.
France1 site
Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,
Marseille, Paca, 13
About this study
Official title: Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism.
Prospective study including all the consecutive patients admitted at the Department of Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched control subject will be included. Primary end point are EE occurring during the antimicrobial treatment and secondary end points will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.
- Conditions
- Infective Endocarditis
- Being tested
- ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic testOther
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | Not described Receives: Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test |
| control | Other | Not described Receives: Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embolic events occurring during the antimicrobial treatment a
Measured: 30 months
Secondary outcomes (1)
Will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.
Measured: 30months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startSep 2008
- Primary completionApr 2010
- Study completionApr 2010
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.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- franck thuny, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947817
- Sponsor's protocol ID
- 2008 07
- Other IDs
- 2008-A00114-51
- Status last verified
- May 2010
- First submitted
- 15 Jan 2009
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism.
- ClinicalTrials.gov ID
- NCT00947817
- Acronym / sponsor ID
- 2008 07
- Conditions
- Infective Endocarditis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Jul 2009 (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.
Prospective study including all the consecutive patients admitted at the Department of Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched control subject will be included. Primary end point are EE occurring during the antimicrobial treatment and secondary end points will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test |
| control | Other | Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All the patients presenting certain diagnosis of infectious endocardite according to the criteria of modified Duke
Key exclusion criteria (5 listed)
- Age < 18 years
- Pregnancy and feeding
- Health not allowing to give the assent
- Innate abnormalities of the haemostasis
- More than a week before the inclu antibiothérapie adapted begun
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 |
|---|---|---|
| ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test | Other | control, patient |
Primary outcome
Embolic events occurring during the antimicrobial treatment a
Time frame: 30 months
1 secondary outcome
Will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.
Time frame: 30months
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 24 Aug 2015.
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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.
franck thuny 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 ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test in people with 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 1 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 24 Aug 2015. 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?
Embolic events occurring during the antimicrobial treatment a (time frame: 30 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 24 Aug 2015.