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A New Antibiotic Prophylaxis 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02115776
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
Hospital Clinico Universitario de Santiago
Information provided by (Responsible Party):
Pedro DIz DIos, University of Santiago de Compostela

Brief Summary:

The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a chlorhexidine mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental extractions.

The study hypothesis is that an antimicrobial regimen with amoxicillin-clavulanate will show higher effectiveness in reducing the prevalence and duration of bacteremia following dental extractions, than that achieved with the classical amoxicillin regimen.


Condition or disease Intervention/treatment Phase
Bacteremia Drug: Amoxicillin-Potassium Clavulanate Drug: Amoxicillin Drug: Chlorhexidine Not Applicable

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 amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a CHX mouthwash (AMX-CLV-CHX) 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, CHX or AMX-CLV; any type of congenital or acquired immunodeficiency; or any known risk factor for bacterial endocarditis. By applying these criteria, 200 patients will be selected and will be randomly distributed into 5 study groups: control group (receiving no prophylaxis), AMX group (receiving 2 g AMX i.v.), AMX-CLV group (receiving 1000/200mg AMX-CLV i.v.), CHX group (receiving a single 0.2% CHX mouthwash for 30 seconds), and AMX-CLV-CHX group (receiving 1000/200mg AMX-CLV i.v. and a single 0.2% CHX mouthwash for 30 seconds).

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Receiving no prophylaxis
Active Comparator: Amoxicillin
Receiving 2 g Amoxicillin intravenously before any dental manipulation and following endotracheal intubation
Drug: Amoxicillin
Administer Amoxicillin following endotracheal intubation prior to single tooth-extraction
Other Name: AMOXICILINA SANDOZ EFG (code 694688)

Experimental: Amoxicillin-Potassium Clavulanate
Receiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. before any dental manipulation and following endotracheal intubation
Drug: Amoxicillin-Potassium Clavulanate
Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction
Other Name: AMOXICILINA + ACIDO CLAVULANICO SANDOZ EFG (code 600144)

Active Comparator: Chlorhexidine (CHX)
Receiving a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation
Drug: Chlorhexidine
Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction
Other Name: Oraldine Perio (code 375725)

Experimental: Amoxicillin-Potassium Clavulanate-CHX
Receiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. and a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation
Drug: Amoxicillin-Potassium Clavulanate
Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction
Other Name: AMOXICILINA + ACIDO CLAVULANICO SANDOZ EFG (code 600144)

Drug: Chlorhexidine
Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction
Other Name: Oraldine Perio (code 375725)




Primary Outcome Measures :
  1. Number of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. 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 dental extraction ]
    Percentage of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction


Secondary Outcome Measures :
  1. Number of participants receiving a prophylactic dosage with amoxicillin i.v. (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 ]
    Percentage of participants receiving a prophylactic dosage with amoxicillin i.v. with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction


Other Outcome Measures:
  1. Number of control participants with bacteremia following dental extractions under general anesthesia [ Time Frame: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction ]
    Percentage of control participants with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction



Information from the National Library of Medicine

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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): NCT02115776


Locations
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Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15782
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
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Study Chair: Pedro Diz, MD,DDS,PhD Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de Santiago
Study Director: Jacobo Limeres, DDS,PhD Universidad de Santiago (Grupo OMEQUI-2117)
Principal Investigator: Javier Alvarez, MD,DDS Universidad de Santiago (Grupo OMEQUI-2117)
Principal Investigator: Javier F Feijoo, MD,DDS,PhD Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de Santiago
Principal Investigator: Marcio Diniz, DDS,PhD Universidad de Santiago (Grupo OMEQUI-2117)
Principal Investigator: Mercedes Outumuro, DDS,PhD Universidad de Santiago (Grupo OMEQUI-2117)
Principal Investigator: Juan Medina, MD,Anest,PhD Hospital Clínico Universitario de Santiago
Principal Investigator: Miguel Castro, MD,DDS, PhD Universidad de Santiago (Grupo OMEQUI-2117)
Principal Investigator: Maximiliano Alvarez, MD,Micro,PhD Hospital Clínico Universitario de Vigo
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pedro DIz DIos, Associate Professor, University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT02115776    
Other Study ID Numbers: PGIDIT05PXIB92501PR
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Pedro DIz DIos, University of Santiago de Compostela:
bacteremia
prophylaxis
antibiotics
dentistry
Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Chlorhexidine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action