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

Sponsor
University of Santiago de Compostela (Other)
Overall Status
Terminated
CT.gov ID
NCT02783404
Collaborator
Hospital Clinico Universitario de Santiago (Other)
40
Enrollment
2
Locations
3
Arms
62.6
Actual Duration (Months)
20
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

PURPOSE: Despite the controversy about the risk of developing bacterial endocarditis of oral origin, numerous Expert Committees in different countries continue to publish prophylactic regimens. To date, the literature is unclear about the role of antimicrobial prophylaxis in the prevention of bacteremia following dental procedures. The aim of this study is to evaluate the efficacy of prophylactic dosage with oral amoxicillin-clavulanate (AMX-CLV) in the prevention of bacteremia following dental extractions.

SELECTION OF THE STUDY GROUP AND STUDY DESIGN: The study group will comprise patients who, for behavioral reasons (autism, learning disabilities, phobias, etc.), will undergo dental extractions under general anesthesia in the Santiago de Compostela University Hospital (Santiago de Compostela, Spain). The following exclusion criteria will be applied: 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 AMX or CLV; any type of congenital or acquired immunodeficiency; or any known risk factor for bacterial endocarditis. By applying these criteria, 150 patients will be selected and will be randomly distributed into 3 study groups: control group (receiving no prophylaxis), AMX-CLV group (receiving 2 g/125 mg oral AMX-CLV), and AMX group (receiving 2 g oral AMX).

COLLECTION OF SAMPLES FOR BLOOD CULTURE: To determine the prevalence of bacteremia, a peripheral venous blood sample (10 ml) will be drawn from each patient at the baseline (before any dental manipulation but after nasotracheal intubation) and 30 s, 15 min, and 1 h after the final dental extraction. Samples will be inoculated in BACTEC plus (Becton Dickinson and Company, Sparks, MD) aerobic and anaerobic blood culture bottles, and will be processed in the Bactec 9240 (Becton Dickinson).

MICROBIOLOGICAL ANALYSIS OF BLOOD CULTURES: A Gram stain will be performed on each positive blood culture. The positive blood cultures in the aerobic media will be subcultured on blood agar and chocolate agar in an atmosphere of 5 to 10% carbon monoxide and on MacConkey agar under aerobic conditions. The same protocol will be used for the positive blood cultures in the anaerobic media, with subculture on Schaedler agar and incubation in an anaerobic atmosphere. The bacteria isolated will be identified by using the battery of biochemical tests provided with the Vitek system for Gram-positive bacteria, Neisseria spp., Haemophilus spp., and obligate anaerobic bacteria. The viridans group streptococci will be classified into five groups, the Streptococcus mitis, S. anginosus, S. salivarius, S. mutans, and S. bovis groups, by applying the Ruoff criteria. Facklam's criteria will be used to identify unusual Streptococcus spp. and other gram-positive cocci in chains.

The subculture and further identification of the isolated bacteria will be performed by conventional microbiological techniques. The collection, handling, and transport of the blood samples for blood culture will be performed according to the recommendations of the Spanish Society of Infectious Diseases and Clinical Microbiology.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following
Actual Study Start Date :
Feb 27, 2017
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
May 17, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Receiving no prophylaxis
Active Comparator: Amoxicillin

Receiving 2 gr oral Amoxicillin before any dental manipulation and following endotracheal intubation Intervention: Drug: Amoxicillin

Drug: Amoxicillin
Receiving 2 gr oral Amoxicillin before dental any manipulation and following endotracheal intubation
Other Names:
  • Amoxicillin (generic drug)

    		•
    Experimental: Amoxicillin-Potassium Clavulanate

    Receiving 2gr/125 mg oral Amoxicillin-Potassium Clavulanate before any dental manipulation and following endotracheal intubation Intervention: Drug: Amoxicillin-Potassium Clavulanate

    Drug: Amoxicillin-Potassium Clavulanate
    Receiving 2 gr/125 mg oral Amoxicillin-Potassium Clavulanate before any dental manipulation and following endotracheal intubation Intervention: Drug: Amoxicillin-Potassium Clavulanate
    Other Names:
  • Amoxicillin-Potassium Clavulanate (generic drug)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bacteremia in participants receiving a prophylactic dosage with oral amoxicillin-clavulanate [Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dent]

      Positive cultures

    Secondary Outcome Measures

    1. Bacteremia in participants receiving a prophylactic dosage with oral amoxicillin [Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction]

      Positive cultures

    2. Bacteremia in participants receiving no prophylaxis [Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction]

      Positive cultures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clinico Universitario de Santiago Santiago de Compostela A Coruña Spain 15782
    2 Santiago de Compostela University Hospital Santiago de Compostela Coruña Spain 15782

    Sponsors and Collaborators

    • University of Santiago de Compostela
    • Hospital Clinico Universitario de Santiago

    Investigators

    • Principal Investigator: Pedro Diz, MD, DDS, PhD, Santiago de Compostela University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Pedro DIz DIos, MD, DDS, PhD, Professor, University of Santiago de Compostela
    ClinicalTrials.gov Identifier:
    NCT02783404
    Other Study ID Numbers:
    • Univ of Santiago de Compostela
    First Posted:
    May 26, 2016
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Pedro DIz DIos, MD, DDS, PhD, Professor, University of Santiago de Compostela
    bacteraemia
    endocarditis
    antibiotic prophylaxis
    dentistry
    Additional relevant MeSH terms:
    Bacteremia
    Endocarditis
    Amoxicillin
    Clavulanic Acid
    Clavulanic Acids

    Study Results

    No Results Posted as of May 24, 2022