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

NCT05613933 | Not Yet Recruiting

• 1 other identifier: CHUBX 2021/24
• Study Type: interventional
• Target: 250,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Registry based randomized controlled trial; antibiotic prophylaxy; dentist; invasive dental procedure; infective endocarditis

Outcome Measures

Primary Outcomes (1)

• Diagnosis of infective endocarditis

  Diagnosis of infective endocarditis due to oral streptococci that occurs within 3 months after an invasive dental procedure

  Within 3 months after an invasive dental procedure

Secondary Outcomes (1)

• Antibiotic prophylaxis rate

  21 days before the dental procedure

Study Arms (2)

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

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.

Interventions

Improved practices OTHER

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…

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Endocarditis, Bacterial; Endocarditis

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Cardiovascular Infections; Cardiovascular Diseases; Heart Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: November 14, 2022
• Study Start: February 1, 2023
• Primary Completion: June 1, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 2, 2023

Record last verified: 2023-01