drugset / Trial / NCT06422221
An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures
Phase 4
Unknown
150 enrolled
University of Santiago de Compostela
Hospital Clinico Universitario de Santiago · collab
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2024-07-15
- Primary completion
- 2025-01-15
- Completion
- 2025-06-30
Publications
- Background Diz Dios P. Infective endocarditis prophylaxis. Oral Dis. 2014 May;20(4):325-8. doi: 10.1111/odi.12221. Epub 2014 Jan 13.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clindamycin | Unknown | 600 mg | Oral |
| Comparator | Doxycycline | Small molecule | 100 mg | Oral |