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BacteraemiaPhase 4NCT02783404

An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following Dental Procedures

A Phase 4 study testing Amoxicillin and Amoxicillin-Potassium Clavulanate in people with Bacteraemia and Endocarditis, run by University of Santiago de Compostela at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bacteraemia, Endocarditis
What is being tested?
Amoxicillin and Amoxicillin-Potassium Clavulanate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesSpain
Study dates
27 Feb 2017to 17 May 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 amoxicillin
  • A history of allergy or intolerance to chlorhexidine
Show all 10Show fewer
  • A history of allergy or intolerance to amoxicillin-clavulanate
  • Any type of congenital or acquired immunodeficiency
  • Any known risk factor for bacterial endocarditis
  • Any known risk factor for prolonged bleeding

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, A Coruña, 15782

  • Santiago de Compostela University Hospital

    Santiago de Compostela, Coruña, 15782

Other trials in Spain

About this study

Official title: An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following

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. Recently, the investigators have evaluated the efficacy of the intravenous administration of 1000/200 mg of amoxicillin/clavulanate for the prevention of bacteraemia following dental extractions. The results of this study suggest that is highly effective, and that it might be considered a first-line choice for patients at high-risk for infective endocarditis who undergo dental procedures and for whom antimicrobial prophylaxis is recommended. This new project aims to evaluate the effectiveness of oral amoxicillin/clavulanate in preventing post-dental extraction bloodstream infection.

Read the 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 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.

Being tested
Amoxicillin, Amoxicillin-Potassium Clavulanate
Keywords
bacteraemia, endocarditis, antibiotic prophylaxis, dentistry
Medical subject headings
Toxemia, Endocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmoxicillinDrug

    Also called Amoxicillin (generic drug)

    Receiving 2 gr oral Amoxicillin before dental any manipulation and following endotracheal intubation

  • Amoxicillin-Potassium ClavulanateDrug

    Also called Amoxicillin-Potassium Clavulanate (generic drug)

    Receiving 2 gr/125 mg oral Amoxicillin-Potassium Clavulanate before any dental manipulation and following endotracheal intubation

    Intervention: Drug: Amoxicillin-Potassium Clavulanate

Study groups in NCT02783404
Study groupRoleWhat they receive
ControlNo interventionReceiving no prophylaxis
AmoxicillinActive comparatorReceiving 2 gr oral Amoxicillin before any dental manipulation and following endotracheal intubation Intervention: Drug: Amoxicillin
Receives: Drug: Amoxicillin
Amoxicillin-Potassium ClavulanateExperimentalReceiving 2gr/125 mg oral Amoxicillin-Potassium Clavulanate before any dental manipulation and following endotracheal intubation Intervention: Drug: Amoxicillin-Potassium Clavulanate
Receives: Drug: Amoxicillin-Potassium Clavulanate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bacteremia in participants receiving a prophylactic dosage with oral amoxicillin-clavulanate

    Positive cultures

    Measured: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dent

Secondary outcomes (2)

  1. Bacteremia in participants receiving a prophylactic dosage with oral amoxicillin

    Positive cultures

    Measured: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction

  2. Bacteremia in participants receiving no prophylaxis

    Positive cultures

    Measured: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2016 (estimated)
  2. Study start27 Feb 2017
  3. Primary completion1 Dec 2021
  4. Study completion17 May 2022

Why it stopped: Significant results (no control neither amoxicillin new arms needed)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02783404
Sponsor's protocol ID
Univ of Santiago de Compostela
Status last verified
May 2022
First submitted
22 May 2016
Last updated
24 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be available on request

Publications

  • Diz Dios P. Infective endocarditis prophylaxis. Oral Dis. 2014 May;20(4):325-8. doi: 10.1111/odi.12221. Epub 2014 Jan 13.

    PubMed 24373017

  • 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.

    PubMed 18477269

  • 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.

    PubMed 20701619

  • 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.

    PubMed 16940094

  • 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.

    PubMed 27029851

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amoxicillin and Amoxicillin-Potassium Clavulanate in people with Bacteraemia and Endocarditis, run by University of Santiago de Compostela at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Significant results (no control neither amoxicillin new arms needed)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacteremia in participants receiving a prophylactic dosage with oral amoxicillin-clavulanate (time frame: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dent). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02783404, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.

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