EndocarditisSATIENCT06107309
Suppressive Antibiotic Therapy for Endocarditis
An observational study of Endocarditis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Endocarditis are deadly infections, which nowadays occurs mainly among older patients with multiple comorbidities. The incidence is notably high among patients with valvular prosthetic or implantable devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to Mar 2024
- 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: Major subject (≥18 years old) having benefited from suppressive antibiotic therapy after collegial decision in CPR Endocarditis during the period from January 1, 2016 to January 31, 2023
Who may be able to join
- Major subject (≥18 years old)
- Subject having benefited from suppressive antibiotic therapy after collegial decision in CPR Endocarditis during the period from January 1, 2016 to January 31, 2023
- Subject not opposing the reuse of their data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study
- Death or loss of sight of the patient before initiation of suppressive antibiotic therapy.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
Yvon RUCH, MD, 33 3 69 55 12 19, yvon.ruch@chru-strasbourg.fr
Thomas LEMMET, MD, 33 3 69 55 12 19, thomas.lemmet@chru-strasbourg.fr
About this study
Official title: Suppressive Antibiotic Therapy for Prosthetic Valve or Implantable Device Related Infectious Endocarditis
Endocarditis are deadly infections, which nowadays occurs mainly among older patients with multiple comorbidities. The incidence is notably high among patients with valvular prosthetic or implantable devices. Management of such situation usually requires intravenous antibiotic therapy along with removal of the infected prosthetic or device. However, such invasive procedures and revision surgeries may be judged unreasonable among these patients, who are then exposed to a high risk of infectious relapse when curative antibiotics are discontinued.
In these situation, a long-course antibiotic therapy may be used in order to maintain lasting infection control, to limit the risks of relapse of infection due to the infected device retention, and ultimately to prolong survival. This strategy is already suggested in case of infected prosthesis joint retention (IDSA 2013), and has been proposed for implantable device retention by the American Heart Rhythm Society in 2017, but data regarding its modalities and outcomes are scare.
The objectives of this study are to describe the survival of patient under long-term antibiotic therapy for endocarditis, at 6-months and 1 year after initiation. Secondary outcomes includes modalities of the suppressive treatment prescribed, its security (secondary effects, tolerance) and to precise causes of death.
- Conditions
- Endocarditis
- Keywords
- Endocarditis, Antibiotic therapy, Suppressive antibiotics, Long term treatment
- Medical subject headings
- Endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the patient who benefited from suppressive antibiotic therapy
Measured: Survival at 6 months, 1 year, 3 years after infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107309
- Sponsor's protocol ID
- 8900
- Acronym
- SATIE
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 2 Nov 2023
- 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppressive Antibiotic Therapy for Prosthetic Valve or Implantable Device Related Infectious Endocarditis
- ClinicalTrials.gov ID
- NCT06107309
- Acronym / sponsor ID
- SATIE / 8900
- Conditions
- Endocarditis
- Keywords
- Endocarditis, Antibiotic therapy, Suppressive antibiotics, Long term treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 30 Oct 2023 (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.
Endocarditis are deadly infections, which nowadays occurs mainly among older patients with multiple comorbidities. The incidence is notably high among patients with valvular prosthetic or implantable devices. Management of such situation usually requires intravenous antibiotic therapy along with removal of the infected prosthetic or device. However, such invasive procedures and revision surgeries may be judged unreasonable among these patients, who are then exposed to a high risk of infectious relapse when curative antibiotics are discontinued.
In these situation, a long-course antibiotic therapy may be used in order to maintain lasting infection control, to limit the risks of relapse of infection due to the infected device retention, and ultimately to prolong survival. This strategy is already suggested in case of infected prosthesis joint retention (IDSA 2013), and has been proposed for implantable device retention by the American Heart Rhythm Society in 2017, but data regarding its modalities and outcomes are scare.
The objectives of this study are to describe the survival of patient under long-term antibiotic therapy for endocarditis, at 6-months and 1 year after initiation. Secondary outcomes includes modalities of the suppressive treatment prescribed, its security (secondary effects, tolerance) and to precise causes of death.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old) having benefited from suppressive antibiotic therapy after collegial decision in CPR Endocarditis during the period from January 1, 2016 to January 31, 2023
Key inclusion criteria (3 listed)
- Major subject (≥18 years old)
- Subject having benefited from suppressive antibiotic therapy after collegial decision in CPR Endocarditis during the period from January 1, 2016 to January 31, 2023
- Subject not opposing the reuse of their data for the purposes of this research.
Key exclusion criteria (2 listed)
- Subject having expressed opposition to participating in the study
- Death or loss of sight of the patient before initiation of suppressive antibiotic therapy.
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
Survival of the patient who benefited from suppressive antibiotic therapy
Time frame: Survival at 6 months, 1 year, 3 years after infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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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.
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, run by University Hospital, Strasbourg, France 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 3 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: status not confirmed, as of the sponsor's last update on 2 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yvon RUCH, MD (33 3 69 55 12 19, yvon.ruch@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the patient who benefited from suppressive antibiotic therapy (time frame: Survival at 6 months, 1 year, 3 years after infection). 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 2 Nov 2023.