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

NCT05613933 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250000

Last updated 2023-02-02

No results posted yet for this study

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.

Conditions

  • Endocarditis, Bacterial
  • Endocarditis
  • Endocarditis Acute and Subacute

Interventions

OTHER

Improved practices

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…

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-06-01
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613933 on ClinicalTrials.gov