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Not Yet Recruiting NCT05613933

Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis for Invasive Dental Procedures in Patients With Prosthetic Heart Valves and/or History of Infective Endocarditis

Conditions: Endocarditis, Bacterial, Endocarditis, Endocarditis Acute and Subacute

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 250000
Sponsor: University Hospital, Bordeaux

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 Criteria

Inclusion Criteria: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.Exclusion Criteria: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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05613933). StuddyBuddy aggregates publicly available trial information.