A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures

NCT02115776 | Completed

• 1 other identifier: PGIDIT05PXIB92501PR
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 2

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.

Conditions

Bacteremia

Keywords

bacteremia; prophylaxis; antibiotics; dentistry

Outcome Measures

Primary Outcomes (1)

• Number of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia following dental extractions

  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

  Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction

Secondary Outcomes (1)

• Number of participants receiving a prophylactic dosage with amoxicillin i.v. (following the American Heart Association´s guidelines) with bacteremia after dental extractions

  Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction

Other Outcomes (1)

• Number of control participants with bacteremia following dental extractions under general anesthesia

  Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction

Study Arms (5)

Control

NO INTERVENTION

Receiving no prophylaxis

Amoxicillin

ACTIVE COMPARATOR

Receiving 2 g Amoxicillin intravenously before any dental manipulation and following endotracheal intubation

Drug: Amoxicillin

Amoxicillin-Potassium Clavulanate

EXPERIMENTAL

Receiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. before any dental manipulation and following endotracheal intubation

Drug: Amoxicillin-Potassium Clavulanate

Chlorhexidine (CHX)

ACTIVE COMPARATOR

Receiving a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation

Drug: Chlorhexidine

Amoxicillin-Potassium Clavulanate-CHX

EXPERIMENTAL

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; Drug: Chlorhexidine

Interventions

Amoxicillin-Potassium Clavulanate DRUG

Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction

Also known as: AMOXICILINA + ACIDO CLAVULANICO SANDOZ EFG (code 600144)

Amoxicillin-Potassium Clavulanate; Amoxicillin-Potassium Clavulanate-CHX

Amoxicillin DRUG

Administer Amoxicillin following endotracheal intubation prior to single tooth-extraction

Also known as: AMOXICILINA SANDOZ EFG (code 694688)

Amoxicillin

Chlorhexidine DRUG

Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction

Also known as: Oraldine Perio (code 375725)

Amoxicillin-Potassium Clavulanate-CHX; Chlorhexidine (CHX)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Hospital Clinico Universitario de Santiago: collaborator

Study Sites (2)

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, 15782, Spain

Location

Santiago de Compostela University Hospital

Santiago de Compostela, Coruña, 15782, Spain

Location

Related Publications (8)

• Tomas I, Alvarez M, Limeres J, Potel C, Medina J, Diz P. Prevalence, duration and aetiology of bacteraemia following dental extractions. Oral Dis. 2007 Jan;13(1):56-62. doi: 10.1111/j.1601-0825.2006.01247.x.

  PMID: 17241431 BACKGROUND

• Tomas I, Pereira F, Llucian R, Poveda R, Diz P, Bagan JV. Prevalence of bacteraemia following third molar surgery. Oral Dis. 2008 Jan;14(1):89-94. doi: 10.1111/j.1601-0825.2006.01359.x.

  PMID: 18173454 BACKGROUND

• Valdes C, Tomas I, Alvarez M, Limeres J, Medina J, Diz P. The incidence of bacteraemia associated with tracheal intubation. Anaesthesia. 2008 Jun;63(6):588-92. doi: 10.1111/j.1365-2044.2008.05449.x.

  PMID: 18477269 BACKGROUND

• Pineiro A, Tomas I, Blanco J, Alvarez M, Seoane J, Diz P. Bacteraemia following dental implants' placement. Clin Oral Implants Res. 2010 Sep;21(9):913-8. doi: 10.1111/j.1600-0501.2010.01928.x.

  PMID: 20701619 BACKGROUND

• Tomas I, Diz P, Tobias A, Scully C, Donos N. Periodontal health status and bacteraemia from daily oral activities: systematic review/meta-analysis. J Clin Periodontol. 2012 Mar;39(3):213-28. doi: 10.1111/j.1600-051X.2011.01784.x. Epub 2011 Sep 15.

  PMID: 22092606 BACKGROUND

• Diz Dios P, Tomas Carmona I, Limeres Posse J, Medina Henriquez J, Fernandez Feijoo J, Alvarez Fernandez M. Comparative efficacies of amoxicillin, clindamycin, and moxifloxacin in prevention of bacteremia following dental extractions. Antimicrob Agents Chemother. 2006 Sep;50(9):2996-3002. doi: 10.1128/AAC.01550-05.

  PMID: 16940094 BACKGROUND

• Diz Dios P. Infective endocarditis prophylaxis. Oral Dis. 2014 May;20(4):325-8. doi: 10.1111/odi.12221. Epub 2014 Jan 13.

  PMID: 24373017 BACKGROUND

• Limeres Posse J, Alvarez Fernandez M, Fernandez Feijoo J, Medina Henriquez J, Lockhart PB, Chu VH, Diz Dios P. Intravenous amoxicillin/clavulanate for the prevention of bacteraemia following dental procedures: a randomized clinical trial. J Antimicrob Chemother. 2016 Jul;71(7):2022-30. doi: 10.1093/jac/dkw081. Epub 2016 Mar 29.

  PMID: 27029851 DERIVED

MeSH Terms

Conditions

Bacteremia

Interventions

Amoxicillin-Potassium Clavulanate Combination; Amoxicillin; Chlorhexidine

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines

Study Officials

• Pedro Diz, MD,DDS,PhD

  Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de Santiago

  STUDY CHAIR

• Jacobo Limeres, DDS,PhD

  Universidad de Santiago (Grupo OMEQUI-2117)

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 16, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

ES (2)