Endocarditis, BacterialPROPHETSNCT05613933
Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis for Invasive Dental Procedures in Patients With Prosthetic Heart Valves and/or History of Infective Endocarditis
A study testing Improved practices in people with Endocarditis, Bacterial and Endocarditis, run by University Hospital, Bordeaux.
Trial summary
Infective endocarditis (IE) continues to cause serious morbidity and mortality. To reduce its incidence, antibiotic prophylaxis has been recommended before invasive dental procedures in patients with at risk predispositions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis, Bacterial, Endocarditis, Endocarditis Acute and Subacute
- What is being tested?
- Improved practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All French Health Territories (Territoires de santé, TDS) will be included and each TDS will contribute as a cluster for randomization.
- All dentists working in each TDS will be included.
- Among individuals receiving an invasive dental procedure, all patients aged 18 years or more identified with prosthetic heart valves or recorded with prior infective endocarditis will be included.
Who cannot join
- No exclusion criteria for health territories, dentists and patient.
- However, dental procedures that had been performed less than 6 months after the date of first implantation of prosthetic heart valve won't be included.
About this study
Official title: Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis Before Invasive Dental Procedures in Patients With Prosthetic Heart Valves and/or History of Infective Endocarditis: a Prospective, Registry-based, Cluster-randomized Trial in Primary Care
Infective endocarditis (IE) continues to cause serious morbidity and mortality. To reduce its incidence, antibiotic prophylaxis has been recommended before invasive dental procedures in patients with at risk predispositions. Several studies have examined the effect of antibiotic prophylaxis on the incidence of IE and have brought conflicting results. The investigators aim to evaluate the effectiveness of antibiotic prophylaxis before invasive dental procedures to prevent oral streptococcal infective endocarditis in patients with prosthetic heart valves and/or history of IE, using a registry-based, cluster-randomized, controlled trial. In secondary objectives, the investigators aim to analyze changes in dentists' practices.
Read the detailed description
Conducting a conventional individual-based RCT to demonstrate the efficacy of antibiotic prophylaxis of IE is unfeasible and unethical but it also seems unacceptable to perpetuate potentially ineffective and ecologically deleterious antibiotic use. Since the conditions for an individual RCT are not met, the procedure performed does not directly involve the drug but rather the practices of the dentists. This trial will be based on the hypothesis that dentists of health territories (territoires de santé; TDS) allocated to the intervention arm will increase their prescription of antibiotic prophylaxis in patients with prosthetic heart valve and/or history of IE. Thus, assuming antibiotic prophylaxis is effective, the intervention arm should be associated with a decrease in the incidence of oral streptococci IE as compared to the control arm.
In the intervention arm, dentists will receive information on the study before the start of the study.Those who consent will receive information with an "antibiotic prophylaxis package" aimed to improve adherence to current guidelines. These interventions will be periodically repeated in order to ensure the persistence of their effect over time.
Among included patients, dental procedures will be classified as invasive if they imply manipulation of the gingival or periapical region of the teeth or a perforation of the oral mucosa. In these patients, exposure to antibiotic prophylaxis will be identified through the dispensation of an antibiotic treatment active against oral streptococci in the 21 days before the dental procedure. At each new invasive procedure, individuals will be followed for 3 months, until the study outcome, hospital admission for valve replacement, or death from any cause
- Being tested
- Improved practices
- Keywords
- Registry based randomized controlled trial, antibiotic prophylaxy, dentist, invasive dental procedure, infective endocarditis
- Medical subject headings
- Endocarditis, Bacterial, Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved practicesOther
A package of tools including: antibiotic prophylaxis guidelines reminders, periodic reminders, the Infectious Endocarditis Prevention Card for patients at risk, practical information targeting both dentists and patients, etc…
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | In the intervention arm, dentists will receive information on the study 8 weeks before the start of the study and will be invited to consent to participate or to opt out Receives: Other: Improved practices |
| Control arm | No intervention | In the clusters randomized to the control arm, no intervention will be performed and no information will be sent to dentists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of infective endocarditis
Diagnosis of infective endocarditis due to oral streptococci that occurs within 3 months after an invasive dental procedure
Measured: Within 3 months after an invasive dental procedure
Secondary outcomes (1)
Antibiotic prophylaxis rate
Antibiotic prophylaxis rate in dentists according to their randomization arm (Health territories) in all patients regardless of the implantation of prosthetic heart valve and/or history of IE and their dental procedures (invasive or not). The antibiotic prophylaxis will be classified as appropriate (following the recommendation/intervention) or inappropriate
Measured: 21 days before the dental procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- More trials run by University Hospital, BordeauxThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2-arm, registry-based, cluster RCT, to be conducted in all French Health Territories (Territoires de santé, TDS) of metropolitan France, which will serve as randomization clusters
- Masking
- None (open label)
- Enrolment
- 250,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613933
- Sponsor's protocol ID
- CHUBX 2021/24
- Acronym
- PROPHETS
- Status last verified
- Jan 2023
- First submitted
- 15 Feb 2022
- Last updated
- 2 Feb 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 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis Before Invasive Dental Procedures in Patients With Prosthetic Heart Valves and/or History of Infective Endocarditis: a Prospective, Registry-based, Cluster-randomized Trial in Primary Care
- ClinicalTrials.gov ID
- NCT05613933
- Acronym / sponsor ID
- PROPHETS / CHUBX 2021/24
- Keywords
- Registry based randomized controlled trial, antibiotic prophylaxy, dentist, invasive dental procedure, infective endocarditis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250,000 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Nov 2022 (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.
Infective endocarditis (IE) continues to cause serious morbidity and mortality. To reduce its incidence, antibiotic prophylaxis has been recommended before invasive dental procedures in patients with at risk predispositions. Several studies have examined the effect of antibiotic prophylaxis on the incidence of IE and have brought conflicting results. The investigators aim to evaluate the effectiveness of antibiotic prophylaxis before invasive dental procedures to prevent oral streptococcal infective endocarditis in patients with prosthetic heart valves and/or history of IE, using a registry-based, cluster-randomized, controlled trial. In secondary objectives, the investigators aim to analyze changes in dentists' practices.
Detailed description
Conducting a conventional individual-based RCT to demonstrate the efficacy of antibiotic prophylaxis of IE is unfeasible and unethical but it also seems unacceptable to perpetuate potentially ineffective and ecologically deleterious antibiotic use. Since the conditions for an individual RCT are not met, the procedure performed does not directly involve the drug but rather the practices of the dentists. This trial will be based on the hypothesis that dentists of health territories (territoires de santé; TDS) allocated to the intervention arm will increase their prescription of antibiotic prophylaxis in patients with prosthetic heart valve and/or history of IE. Thus, assuming antibiotic prophylaxis is effective, the intervention arm should be associated with a decrease in the incidence of oral streptococci IE as compared to the control arm.
In the intervention arm, dentists will receive information on the study before the start of the study.Those who consent will receive information with an "antibiotic prophylaxis package" aimed to improve adherence to current guidelines. These interventions will be periodically repeated in order to ensure the persistence of their effect over time.
Among included patients, dental procedures will be classified as invasive if they imply manipulation of the gingival or periapical region of the teeth or a perforation of the oral mucosa. In these patients, exposure to antibiotic prophylaxis will be identified through the dispensation of an antibiotic treatment active against oral streptococci in the 21 days before the dental procedure. At each new invasive procedure, individuals will be followed for 3 months, until the study outcome, hospital admission for valve replacement, or death from any cause
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 2-arm, registry-based, cluster RCT, to be conducted in all French Health Territories (Territoires de santé, TDS) of metropolitan France, which will serve as randomization clusters
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Improved practicesIn the intervention arm, dentists will receive information on the study 8 weeks before the start of the study and will be invited to consent to participate or to opt out |
| Control arm | No intervention | –In the clusters randomized to the control arm, no intervention will be performed and no information will be sent to dentists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All French Health Territories (Territoires de santé, TDS) will be included and each TDS will contribute as a cluster for randomization.
- All dentists working in each TDS will be included.
- Among individuals receiving an invasive dental procedure, all patients aged 18 years or more identified with prosthetic heart valves or recorded with prior infective endocarditis will be included.
Key exclusion criteria (2 listed)
- No exclusion criteria for health territories, dentists and patient.
- However, dental procedures that had been performed less than 6 months after the date of first implantation of prosthetic heart valve won't be included.
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 |
|---|---|---|
| Improved practicesA package of tools including: antibiotic prophylaxis guidelines reminders, periodic reminders, the Infectious Endocarditis Prevention Card for patients at risk, practical information targeting both dentists and patients, etc… | Other | Intervention arm |
Primary outcome
Diagnosis of infective endocarditis
Time frame: Within 3 months after an invasive dental procedure
Diagnosis of infective endocarditis due to oral streptococci that occurs within 3 months after an invasive dental procedure
1 secondary outcome
Antibiotic prophylaxis rate
Time frame: 21 days before the dental procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
Related trials for Endocarditis, Bacterial
Not yet recruiting
Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
Transcatheter Aortic Valve Implantation, Dental
RecruitingPhase 3
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
Infective Endocarditis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Improved practices in people with Endocarditis, Bacterial and Endocarditis, run by University Hospital, Bordeaux.
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: opening soon, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnosis of infective endocarditis (time frame: Within 3 months after an invasive dental procedure). 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 Feb 2023.