Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422221
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-14
Brief Title:
An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures
Sponsor:
University of Santiago de Compostela
Organization:
University of Santiago de Compostela
Study Overview
Official Title:
An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Facklams 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
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 Facklams 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None