NCT02783404

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

February 27, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

4.8 years

First QC Date

May 22, 2016

Last Update Submit

May 17, 2022

Conditions

BacteraemiaEndocarditis

Keywords

bacteraemiaendocarditisantibiotic prophylaxisdentistry

Outcome Measures

Primary Outcomes (1)

  • Bacteremia in participants receiving a prophylactic dosage with oral amoxicillin-clavulanate

    Positive cultures

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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Control

NO INTERVENTION

Receiving no prophylaxis

Amoxicillin

ACTIVE COMPARATOR

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

Drug: Amoxicillin

Amoxicillin-Potassium Clavulanate

EXPERIMENTAL

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

Interventions

AmoxicillinDRUG

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

Also known as: Amoxicillin (generic drug)
Amoxicillin
Amoxicillin-Potassium ClavulanateDRUG

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

Also known as: Amoxicillin-Potassium Clavulanate (generic drug)
Amoxicillin-Potassium Clavulanate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 (5)

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

    PMID: 24373017BACKGROUND

  • 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: 18477269RESULT

  • 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: 20701619RESULT

  • 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: 16940094RESULT

  • 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: 27029851RESULT

MeSH Terms

Conditions

ToxemiaEndocarditis

Interventions

AmoxicillinDrugs, GenericAmoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

InfectionsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPharmaceutical PreparationsClavulanic AcidClavulanic AcidsDrug Combinations

Study Officials

  • Pedro Diz, MD, DDS, PhD

    Santiago de Compostela University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DDS, PhD, Professor

Study Record Dates

First Submitted

May 22, 2016

First Posted

May 26, 2016

Study Start

February 27, 2017

Primary Completion

December 1, 2021

Study Completion

May 17, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

IPD will be available on request

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
By the end of the study (for 1 year)
Access Criteria
On request

Locations

ES(2)