An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following Dental Procedures
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|ClinicalTrials.gov Identifier: NCT02783404|
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : October 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bacteraemia Endocarditis||Drug: Amoxicillin Drug: Amoxicillin-Potassium Clavulanate||Phase 4|
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 amoxicillin-clavulanate (AMX-CLV) 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). The following exclusion criteria will be applied: 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 AMX or CLV; any type of congenital or acquired immunodeficiency; or any known risk factor for bacterial endocarditis. By applying these criteria, 150 patients will be selected and will be randomly distributed into 3 study groups: control group (receiving no prophylaxis), AMX-CLV group (receiving 2 g/125 mg oral AMX-CLV), and AMX group (receiving 2 g oral AMX).
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 at the baseline (before any dental manipulation but after nasotracheal intubation) and 30 s, 15 min, and 1 h after the final dental extraction. 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 (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following|
|Actual Study Start Date :||February 27, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
No Intervention: Control
Receiving no prophylaxis
Active Comparator: Amoxicillin
Receiving 2 gr oral Amoxicillin before any dental manipulation and following endotracheal intubation
Intervention: Drug: Amoxicillin
Receiving 2 gr oral Amoxicillin before dental any manipulation and following endotracheal intubation
Experimental: Amoxicillin-Potassium Clavulanate
Receiving 2gr/125 mg oral Amoxicillin-Potassium Clavulanate before any dental manipulation and following endotracheal intubation
Intervention: Drug: Amoxicillin-Potassium Clavulanate
Drug: Amoxicillin-Potassium Clavulanate
Receiving 2 gr/125 mg oral Amoxicillin-Potassium Clavulanate before any dental manipulation and following endotracheal intubation
Intervention: Drug: Amoxicillin-Potassium Clavulanate
- Number of participants receiving a prophylactic dosage with oral amoxicillin-with bacteremia following dental extractions [ Time Frame: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dent ]Positive cultures
- Number of participants receiving a prophylactic dosage with oral amoxicillin(following the American Heart Association´s guidelines) with bacteremia after dental extractions [ Time Frame: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction ]Positive cultures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783404
|Contact: Jacobo Limeres, DDS, PhD||+34881812344 ext firstname.lastname@example.org|
|Hospital Clinico Universitario de Santiago||Recruiting|
|Santiago de Compostela, A Coruña, Spain, 15782|
|Contact: Pedro Diz, MD,DD,PhD +34881812344 ext 12344 email@example.com|
|Santiago de Compostela University Hospital||Recruiting|
|Santiago de Compostela, Coruña, Spain, 15782|
|Contact: Pedro Diz, MD, DDS, PHD|
|Principal Investigator:||Pedro Diz, MD, DDS, PhD||Santiago de Compostela University|