Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis for Invasive Dental Procedures in Patients With Prosthetic Heart Valves (PROPHETS)

January 17, 2023 updated by: University Hospital, Bordeaux

Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis Before Invasive Dental Procedures in Patients With Prosthetic Heart Valves: a Prospective, Registry-based, Cluster-randomized Trial in Primary Care

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

250000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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…
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of infective endocarditis
Time Frame: Within 3 months after an invasive dental procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic prophylaxis rate
Time Frame: 21 days before the dental procedure
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
21 days before the dental procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2021/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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