Infective Endocarditis (IE)NCT02856607
Impact of Clinical Care Pathway on Prognosis and Therapeutic Medical Care of Infective Endocarditis
An observational study of Infective Endocarditis (IE), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner surface of the heart), which may include one or more heart valves. Epidemiologic pattern has changed during the last 20 years whereas the incidence was unchanged. 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?
- determine the prognosis of threated patients according to the clinical care pathway.
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Dec 2018
- 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 adults with infective endocarditis episode
Who may be able to join
- adult with infective endocarditis episode according to Duke Criteria
Who cannot join
- Patients with a new episode of infective endocarditis that led to its prior inclusion in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpoitaux de Marseille Hôpital de la Timone
Marseille, 13354
Gilbert HABIB, 04 91 38 75 87, gilbert.habib@ap-hm.fr
About this study
Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner surface of the heart), which may include one or more heart valves. Epidemiologic pattern has changed during the last 20 years whereas the incidence was unchanged. However, the mortality increase despite recent diagnosis and therapeutic advances.
Only few investigations consider the prognostic and the therapeutic medical care according to the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery, (ii) patients secondary addressed to a referent center with cardiac surgery, (iii) patients for which the totality medical care are performed in non-referent health center. In addition, epidemiologic studies concern only a part of IE, not including most of the time the patients hospitalized in non-referent center.
Read more
The aim of the study was to determine the prognosis of threated patients according to the clinical care pathway. Secondary objectives was (i) to evaluate the application of European recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and surgical practice, (ii) to compare the epidemiologic profile according to the type of center.
For this, 300 patients addressed in the 22 French participating centers for a possible or certain IE according to Duke Criteria were prospectively included during 3 years.
Patient data (clinical, demographical, biological, microbiological, echocardiographic and evolutive data) were collected at the admission, during hospitalization, at discharge and one-year follow up.
- Conditions
- Infective Endocarditis (IE)
- Being tested
- determine the prognosis of threated patients according to the clinical care pathway.
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determine the prognosis of threated patients according to the clinical care pathway.Other
| Study group | Role | What they receive |
|---|---|---|
| Group I | patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery Receives: Other: determine the prognosis of threated patients according to the clinical care pathway. | |
| Group II | patients secondary addressed to a referent center with cardiac surgery Receives: Other: determine the prognosis of threated patients according to the clinical care pathway. | |
| Group III | patients for which the totality medical care are performed in non-referent health center Receives: Other: determine the prognosis of threated patients according to the clinical care pathway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the all-cause one-year mortality according to the group
Measured: one year
Secondary outcomes (3)
the application of European recommendations
realization of trans-oesophageal echocardiogram (TOE)
Measured: one year
antibiotic treatment
type and time of antibiotic treatment for common germ,
Measured: one year
surgery
performing valve surgery and / or total extraction of an implanted pacemaker or defibrillator.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completionFeb 2018 (estimated)
- Study completionDec 2018 (estimated)
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
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 Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856607
- Sponsor's protocol ID
- RC12_3675
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Care Pathway on Prognosis and Therapeutic Medical Care of Infective Endocarditis
- ClinicalTrials.gov ID
- NCT02856607
- Acronym / sponsor ID
- RC12_3675
- Conditions
- Infective Endocarditis (IE)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Aug 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 (IE) is defined as a bacterial infection of the endocardium (inner surface of the heart), which may include one or more heart valves. Epidemiologic pattern has changed during the last 20 years whereas the incidence was unchanged. However, the mortality increase despite recent diagnosis and therapeutic advances.
Only few investigations consider the prognostic and the therapeutic medical care according to the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery, (ii) patients secondary addressed to a referent center with cardiac surgery, (iii) patients for which the totality medical care are performed in non-referent health center. In addition, epidemiologic studies concern only a part of IE, not including most of the time the patients hospitalized in non-referent center.
The aim of the study was to determine the prognosis of threated patients according to the clinical care pathway. Secondary objectives was (i) to evaluate the application of European recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and surgical practice, (ii) to compare the epidemiologic profile according to the type of center.
For this, 300 patients addressed in the 22 French participating centers for a possible or certain IE according to Duke Criteria were prospectively included during 3 years.
Patient data (clinical, demographical, biological, microbiological, echocardiographic and evolutive data) were collected at the admission, during hospitalization, at discharge and one-year follow up.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: determine the prognosis of threated patients according to the clinical care pathway.patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery |
| Group II | – | Other: determine the prognosis of threated patients according to the clinical care pathway.patients secondary addressed to a referent center with cardiac surgery |
| Group III | – | Other: determine the prognosis of threated patients according to the clinical care pathway.patients for which the totality medical care are performed in non-referent health center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all adults with infective endocarditis episode
Key inclusion criteria (1 listed)
- adult with infective endocarditis episode according to Duke Criteria
Key exclusion criteria (1 listed)
- Patients with a new episode of infective endocarditis that led to its prior inclusion in the study
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 |
|---|---|---|
| determine the prognosis of threated patients according to the clinical care pathway. | Other | Group I, Group II, Group III |
Primary outcome
the all-cause one-year mortality according to the group
Time frame: one year
3 secondary outcomes
the application of European recommendations
Time frame: one year
antibiotic treatment
Time frame: one year
surgery
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
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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 Hôpitaux de Marseille
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 (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 1 inclusion and 1 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 5 Aug 2016. 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 Gilbert HABIB (04 91 38 75 87, gilbert.habib@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the all-cause one-year mortality according to the group (time frame: 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 Aug 2016.