An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures

NCT06422221 | Not Yet Recruiting Phase 4

• 1 other identifier: Doxycycline Regimen
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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. The last American Heart Association (AHA) and European Society of Cardiology (ESC) guidelines include several important changes, highlighting that clindamycin (CLI) is no longer recommended as an alternative to amoxicillin in those allergic to penicillin. This new project aims to evaluate the effectiveness of oral doxycycline in preventing post-dental extraction bloodstream infection.

Conditions

Bacteremia; Endocarditis

Outcome Measures

Primary Outcomes (1)

• Bacteremia in participants receiving a prophylactic dosage with oral doxycyclin

  Positive cultures

  Changes from baseline at 30 seconds and 15 minutes after the final dental extraction

Secondary Outcomes (2)

• Bacteremia in participants receiving a prophylactic dosage with oral clindamycin

  Changes from baseline at 30 seconds and 15 minutes after the final dental extraction

• Bacteremia in participants receiving no prophylaxis

  Changes from baseline at 30 seconds and 15 minutes after the final dental extraction

Study Arms (3)

No Intervention

NO INTERVENTION

Receiving no prophylaxis

Clindamycin

ACTIVE COMPARATOR

Receiving 600 mg oral Clindamycin 1 hour before general anesthesia and before any dental manipulation

Drug: Clindamycin

Doxycycline

ACTIVE COMPARATOR

Receiving 100 mg oral Doxycycline 1 hour before general anesthesia and before any dental manipulation

Drug: Doxycycline

Interventions

Clindamycin DRUG

Receiving 600 mg oral Clindamycin 1 hour before general anesthesia and before any dental manipulation

Clindamycin

Doxycycline DRUG

Receiving 100 mg oral Doxycycline 1 hour before general anesthesia and before any dental manipulation

Doxycycline

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 doxycycline
• A history of allergy or intolerance to cindamycin
• 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 (1)

Santiago de Compostela University Hospital

Santiago de Compostela, A Coruña, 15782, Spain

Location

Related Publications (12)

• 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

• 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

• 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

• 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 BACKGROUND

• Relvas M, Diz P, Seoane J, Tomas I. Oral Health Scales: design of an oral health scale of infectious potential. Med Oral Patol Oral Cir Bucal. 2013 Jul 1;18(4):e664-70. doi: 10.4317/medoral.18427.

  PMID: 23524418 BACKGROUND

• Martins CC, Lockhart PB, Firmino RT, Kilmartin C, Cahill TJ, Dayer M, Occhi-Alexandre IGP, Lai H, Ge L, Thornhill MH. Bacteremia following different oral procedures: Systematic review and meta-analysis. Oral Dis. 2024 Apr;30(3):846-854. doi: 10.1111/odi.14531. Epub 2023 Mar 29.

  PMID: 36750413 BACKGROUND

• Thornhill MH, Gibson TB, Yoon F, Dayer MJ, Prendergast BD, Lockhart PB, O'Gara PT, Baddour LM. Endocarditis, invasive dental procedures, and antibiotic prophylaxis efficacy in US Medicaid patients. Oral Dis. 2024 Apr;30(3):1591-1605. doi: 10.1111/odi.14585. Epub 2023 Apr 27.

  PMID: 37103475 BACKGROUND

• Diniz Freitas M, Alvarez Fernandez M, Vasallo Vidal FJ, Limeres Posse J, Diz Dios P, Fernandez Feijoo J. Oral amoxicillin/clavulanate for the prevention of bacteremia following dental extractions. Oral Dis. 2023 Jul;29(5):2272-2276. doi: 10.1111/odi.14221. Epub 2022 May 13.

  PMID: 35467064 BACKGROUND

• Dayer MJ, Jones S, Prendergast B, Baddour LM, Lockhart PB, Thornhill MH. Incidence of infective endocarditis in England, 2000-13: a secular trend, interrupted time-series analysis. Lancet. 2015 Mar 28;385(9974):1219-28. doi: 10.1016/S0140-6736(14)62007-9. Epub 2014 Nov 18.

  PMID: 25467569 BACKGROUND

• Lean SSH, Jou E, Ho JSY, Jou EGL. Prophylactic antibiotic use for infective endocarditis: a systematic review and meta-analysis. BMJ Open. 2023 Aug 22;13(8):e077026. doi: 10.1136/bmjopen-2023-077026.

  PMID: 37607797 BACKGROUND

• Dayer MJ, Thornhill M, Baddour LM. Antibiotic prophylaxis for patients at risk of infective endocarditis: an increasing evidence base? Br J Cardiol. 2023 Feb 21;30(1):6. doi: 10.5837/bjc.2023.006. eCollection 2023.

  PMID: 37705833 BACKGROUND

MeSH Terms

Conditions

Bacteremia; Endocarditis

Interventions

Clindamycin; Doxycycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Pedro Diz Dios

  Santiago de Compostela University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JAVIER Feijoo

CONTACT

+34636962202; javier.fernandez@usc.es

Pedro Diz Dios

CONTACT

+34617864293; pedro.diz@usc.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: July 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: June 30, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: By the end of the study (for 1 year)
• Access Criteria: On request

Locations

ES (1)