Endocarditis, BacterialNCT03306225
Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients
An observational study of Endocarditis, Bacterial, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The infectious endocarditis is a grave infection the incidence of which is at present esteemed at 30-100 episodes by million inhabitants a year. This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an abnormally high death rate at the patients presenting an infectious endocarditis to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis, Bacterial
- How many people
- 414 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2016to 31 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: all patient diagnostised for endocarditis between 2010 and 2015
Who may be able to join
- age > 18 years
- endocartitis with steptococci with Duke's criteria
Who cannot join
- age < 18 years
- suspiscious endocarditis without Duke's criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The infectious endocarditis is a grave infection the incidence of which is at present esteemed at 30-100 episodes by million inhabitants a year.
This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an abnormally high death rate at the patients presenting an infectious endocarditis to streptococci with an inhibitive minimal concentration raised to the amoxicilline. The aim of the study is to describe the epidemiology and the clinical presentations of the patients presenting an endocarditis to streptococci
- Conditions
- Endocarditis, Bacterial
- Medical subject headings
- Endocarditis, Bacterial
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of factors associated to the mortality in the patients presenting an endocarditis to streptococci.
Measured: an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start8 Jul 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocarditis, BacterialStudies 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
- Retrospective
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PILMIS P Benoit, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306225
- Sponsor's protocol ID
- ENDOSTREPTO
- Status last verified
- Jan 2020
- First submitted
- 5 Oct 2017
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients
- ClinicalTrials.gov ID
- NCT03306225
- Acronym / sponsor ID
- ENDOSTREPTO
- Conditions
- Endocarditis, Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Oct 2017 (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.
The infectious endocarditis is a grave infection the incidence of which is at present esteemed at 30-100 episodes by million inhabitants a year.
This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an abnormally high death rate at the patients presenting an infectious endocarditis to streptococci with an inhibitive minimal concentration raised to the amoxicilline. The aim of the study is to describe the epidemiology and the clinical presentations of the patients presenting an endocarditis to streptococci
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patient diagnostised for endocarditis between 2010 and 2015
Key inclusion criteria (2 listed)
- age > 18 years
- endocartitis with steptococci with Duke's criteria
Key exclusion criteria (2 listed)
- age < 18 years
- suspiscious endocarditis without Duke's criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of factors associated to the mortality in the patients presenting an endocarditis to streptococci.
Time frame: an average of one year
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 5 Feb 2020.
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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.
PILMIS P Benoit, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Endocarditis, Bacterial, run by Fondation Hôpital Saint-Joseph 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 2 inclusion and 2 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 5 Feb 2020. 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?
Evaluation of factors associated to the mortality in the patients presenting an endocarditis to streptococci. (time frame: an average of one year). 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 5 Feb 2020.