Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    "Endocarditis" | "Amoxicillin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02783404
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Hospital Clinico Universitario de Santiago
Information provided by (Responsible Party):
Pedro DIz DIos, University of Santiago de Compostela

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
Bacteraemia Endocarditis Drug: Amoxicillin Drug: Amoxicillin-Potassium Clavulanate 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 : February 27, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019


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

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





Primary Outcome Measures :
  1. Number of participants receiving a prophylactic dosage with oral amoxicillin-with bacteremia following dental extractions [ Time Frame: 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. Number of participants receiving a prophylactic dosage with oral amoxicillin(following the American Heart Association´s guidelines) with bacteremia after dental extractions [ Time Frame: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction ]
    Positive cultures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783404


Contacts
Layout table for location contacts
Contact: Jacobo Limeres, DDS, PhD +34881812344 ext 12344 jacobo.limeres@usc.es

Locations
Layout table for location information
Spain
Hospital Clinico Universitario de Santiago Recruiting
Santiago de Compostela, A Coruña, Spain, 15782
Contact: Pedro Diz, MD,DD,PhD    +34881812344 ext 12344    pedro.diz@usc.es   
Santiago de Compostela University Hospital Recruiting
Santiago de Compostela, Coruña, Spain, 15782
Contact: Pedro Diz, MD, DDS, PHD         
Sponsors and Collaborators
University of Santiago de Compostela
Hospital Clinico Universitario de Santiago
Investigators
Layout table for investigator information
Principal Investigator: Pedro Diz, MD, DDS, PhD Santiago de Compostela University

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Pedro DIz DIos, MD, DDS, PhD, Professor, University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT02783404     History of Changes
Other Study ID Numbers: Univ of Santiago de Compostela
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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, University of Santiago de Compostela:
bacteraemia
endocarditis
antibiotic prophylaxis
dentistry
Additional relevant MeSH terms:
Layout table for MeSH terms
Endocarditis
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Clavulanic Acid
Clavulanic Acids
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action