An interventional study of Improved practices in Endocarditis, Bacterial, Endocarditis and Endocarditis Acute and Subacute, sponsored by University Hospital, Bordeaux. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Prevention
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.
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
22 studies on the registry are indexed under Endocarditis, Bacterial; 9 are open to participants now.
This study's planned enrollment of 250,000 is above the median of 38 across 11 interventional studies indexed under Endocarditis, Bacterial.
Browse Endocarditis, Bacterial studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Exclusion Criteria:
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
Other: Improved practices
In the clusters randomized to the control arm, no intervention will be performed and no information will be sent to dentists.
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...
Diagnosis of infective endocarditis
Diagnosis of infective endocarditis due to oral streptococci that occurs within 3 months after an invasive dental procedure
Time frame: Within 3 months after an invasive dental procedure
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
Time frame: 21 days before the dental procedure
No study locations are listed for this record.
Start is estimated for Feb 2023; primary completion for Jun 2023, 4 months later.
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This study is not yet recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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