An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following Dental Procedures

• Status: Recruiting
• Trial end date: 2021-12-27
• Target enrollment: 0
• Participant gender: All

Summary

Although controversy exists regarding the efficacy of antibiotic prophylaxis for patients at risk of infective endocarditis, expert committees continue to publish recommendations for antibiotic prophylactic regimens. Recently, the investigators have evaluated the efficacy of the intravenous administration of 1000/200 mg of amoxicillin/clavulanate for the prevention of bacteraemia following dental extractions. The results of this study suggest that is highly effective, and that it might be considered a first-line choice for patients at high-risk for infective endocarditis who undergo dental procedures and for whom antimicrobial prophylaxis is recommended. This new project aims to evaluate the effectiveness of oral amoxicillin/clavulanate in preventing post-dental extraction bloodstream infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Santiago de Compostela
• Collaborator: Hospital Clinico Universitario de Santiago
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acid; Clavulanic Acids; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Subjects must have at least 10 teeth

• Subjects must have the need for a dental extraction under general anesthesia (for behavioral reasons)

• Subjects will be recruited regardless of the extent and severity of their dental and/or periodontal disease

Exclusion Criteria:

• Age under 18 years

• Body weight under 40 kg

• Receipt of antibiotics in the previous 3 months

• Routine use of oral antiseptics

• A history of allergy or intolerance to amoxicillin

• A history of allergy or intolerance to chlorhexidine

• A history of allergy or intolerance to amoxicillin-clavulanate

• Any type of congenital or acquired immunodeficiency

• Any known risk factor for bacterial endocarditis

• Any known risk factor for prolonged bleeding