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

Status: Not_yet_recruiting
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Time Frame
Start Date: 2023-02-01
Completion Date: 2027-12-31
Participants
Target number of participants: 250000
Treatments
Experimental: Intervention arm
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
No_intervention: Control arm
In the clusters randomized to the control arm, no intervention will be performed and no information will be sent to dentists.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov