An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures

June 13, 2024 updated by: Pedro DIz DIos, University of Santiago de Compostela
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PURPOSE: Despite the controversy about the risk of developing bacterial endocarditis of oral origin, numerous Expert Committees in different countries continue to publish prophylactic regimens. To date, the literature is unclear about the role of antimicrobial prophylaxis in the prevention of bacteremia following dental procedures. The aim of this study is to evaluate the efficacy of prophylactic dosage with oral doxycycline (DXC) in the prevention of bacteremia following dental extractions.

SELECTION OF THE STUDY GROUP AND STUDY DESIGN: The study group will comprise patients who, for behavioral reasons (autism, learning disabilities, phobias, etc.), will undergo dental extractions under general anesthesia in the Santiago de Compostela University Hospital (Santiago de Compostela, Spain). 150 patients will be selected and will be randomly distributed into 3 study groups: control group (receiving no prophylaxis), CLI group (receiving 600 mg oral CLI) and DXC group (receiving 100 mg oral DXC).

COLLECTION OF SAMPLES FOR BLOOD CULTURE: To determine the prevalence of bacteremia, a peripheral venous blood sample (10 ml) will be drawn from each patient. Samples will be inoculated in BACTEC plus (Becton Dickinson and Company, Sparks, MD) aerobic and anaerobic blood culture bottles, and will be processed in the Bactec 9240 (Becton Dickinson).

MICROBIOLOGICAL ANALYSIS OF BLOOD CULTURES: A Gram stain will be performed on each positive blood culture. The positive blood cultures in the aerobic media will be subcultured on blood agar and chocolate agar in an atmosphere of 5 to 10% carbon monoxide and on MacConkey agar under aerobic conditions. The same protocol will be used for the positive blood cultures in the anaerobic media, with subculture on Schaedler agar and incubation in an anaerobic atmosphere. The bacteria isolated will be identified by using the battery of biochemical tests provided with the Vitek system for Gram-positive bacteria, Neisseria spp., Haemophilus spp., and obligate anaerobic bacteria. The viridans group streptococci will be classified into five groups, the Streptococcus mitis, S. anginosus, S. salivarius, S. mutans, and S. bovis groups, by applying the Ruoff criteria. Facklam's criteria will be used to identify unusual Streptococcus spp. and other Gram-positive cocci in chains.

The subculture and further identification of the isolated bacteria will be performed by conventional microbiological techniques. The collection, handling, and transport of the blood samples for blood culture will be performed according to the recommendations of the Spanish Society of Infectious Diseases and Clinical Microbiology.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15782

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Intervention
Receiving no prophylaxis
Active Comparator: Clindamycin
Receiving 600 mg oral Clindamycin 1 hour before general anesthesia and before any dental manipulation
Drug: Clindamycin
Receiving 600 mg oral Clindamycin 1 hour before general anesthesia and before any dental manipulation
Active Comparator: Doxycycline
Receiving 100 mg oral Doxycycline 1 hour before general anesthesia and before any dental manipulation
Drug: Doxycycline
Receiving 100 mg oral Doxycycline 1 hour before general anesthesia and before any dental manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacteremia in participants receiving a prophylactic dosage with oral doxycyclin
Time Frame: Changes from baseline at 30 seconds and 15 minutes after the final dental extraction
Positive cultures
Changes from baseline at 30 seconds and 15 minutes after the final dental extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacteremia in participants receiving a prophylactic dosage with oral clindamycin
Time Frame: Changes from baseline at 30 seconds and 15 minutes after the final dental extraction
Positive cultures
Changes from baseline at 30 seconds and 15 minutes after the final dental extraction
Bacteremia in participants receiving no prophylaxis
Time Frame: Changes from baseline at 30 seconds and 15 minutes after the final dental extraction
Positive cultures
Changes from baseline at 30 seconds and 15 minutes after the final dental extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Collaborators

Hospital Clinico Universitario de Santiago

Investigators

  • Principal Investigator: Pedro Diz Dios, Santiago de Compostela University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2024

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 18, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doxycycline Regimen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available on request

IPD Sharing Time Frame

By the end of the study (for 1 year)

IPD Sharing Access Criteria

On request

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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