An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Santiago de Compostela
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age under 18 years
Body weight under 40 kg
Receipt of antibiotics in the previous 3 months
Routine use of oral antiseptics
Trial design
Design model
Parallel
Treatments tested in this trial
Clindamycin
DrugReceiving 600 mg oral Clindamycin 1 hour before general anesthesia and before any dental manipulation
Doxycycline
DrugReceiving 100 mg oral Doxycycline 1 hour before general anesthesia and before any dental manipulation
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: No InterventionNo intervention 0 interventions
Group B: ClindamycinActive comparator 1 intervention
Group C: DoxycyclineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bacteremia in participants receiving a prophylactic dosage with oral doxycyclin
Positive cultures
Time frame
Changes from baseline at 30 seconds and 15 minutes after the final dental extractionSecondary outcomes
1
Bacteremia in participants receiving a prophylactic dosage with oral clindamycin
Positive cultures
Time frame
Changes from baseline at 30 seconds and 15 minutes after the final dental extraction2
Bacteremia in participants receiving no prophylaxis
Positive cultures
Time frame
Changes from baseline at 30 seconds and 15 minutes after the final dental extractionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Santiago de Compostela
Lead sponsor
Hospital Clinico Universitario de Santiago
Collaborator
Source ClinicalTrials.gov
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