BacteremiaNCT02115776
A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures
A study testing Amoxicillin-Potassium Clavulanate, Amoxicillin and Chlorhexidine in people with Bacteremia, run by University of Santiago de Compostela at 2 sites in Spain.
Trial summary
The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a chlorhexidine mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental extractions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bacteremia
- What is being tested?
- Amoxicillin-Potassium Clavulanate, Amoxicillin and Chlorhexidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2014to May 2015
- Phase
- Interventional
- 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
About this study
The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a chlorhexidine mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental extractions.
The study hypothesis is that an antimicrobial regimen with amoxicillin-clavulanate will show higher effectiveness in reducing the prevalence and duration of bacteremia following dental extractions, than that achieved with the classical amoxicillin regimen.
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 amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a CHX mouthwash (AMX-CLV-CHX) 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, CHX or AMX-CLV; any type of congenital or acquired immunodeficiency; or any known risk factor for bacterial endocarditis. By applying these criteria, 200 patients will be selected and will be randomly distributed into 5 study groups: control group (receiving no prophylaxis), AMX group (receiving 2 g AMX i.v.), AMX-CLV group (receiving 1000/200mg AMX-CLV i.v.), CHX group (receiving a single 0.2% CHX mouthwash for 30 seconds), and AMX-CLV-CHX group (receiving 1000/200mg AMX-CLV i.v. and a single 0.2% CHX mouthwash for 30 seconds).
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.
.
- Conditions
- Bacteremia
- Being tested
- Amoxicillin-Potassium Clavulanate, Amoxicillin, Chlorhexidine
- Keywords
- bacteremia, prophylaxis, antibiotics, dentistry
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-Potassium ClavulanateDrug
Also called AMOXICILINA + ACIDO CLAVULANICO SANDOZ EFG (code 600144)
Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction
AmoxicillinDrug
Also called AMOXICILINA SANDOZ EFG (code 694688)
Administer Amoxicillin following endotracheal intubation prior to single tooth-extraction
ChlorhexidineDrug
Also called Oraldine Perio (code 375725)
Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receiving no prophylaxis |
| Amoxicillin | Active comparator | Receiving 2 g Amoxicillin intravenously before any dental manipulation and following endotracheal intubation Receives: Drug: Amoxicillin |
| Amoxicillin-Potassium Clavulanate | Experimental | Receiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. before any dental manipulation and following endotracheal intubation Receives: Drug: Amoxicillin-Potassium Clavulanate |
| Chlorhexidine (CHX) | Active comparator | Receiving a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation Receives: Drug: Chlorhexidine |
| Amoxicillin-Potassium Clavulanate-CHX | Experimental | Receiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. and a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation Receives: Drug: Amoxicillin-Potassium Clavulanate; Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia following dental extractions
Percentage of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction
Measured: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction
Secondary outcomes (1)
Number of participants receiving a prophylactic dosage with amoxicillin i.v. (following the American Heart Association´s guidelines) with bacteremia after dental extractions
Percentage of participants receiving a prophylactic dosage with amoxicillin i.v. with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction
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.
- First posted16 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinico Universitario de Santiago
- Responsible party
- Principal investigator, Pedro DIz DIos, University of Santiago de Compostela
- Investigators
- Pedro Diz, MD,DDS,PhD, Study chair, Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de SantiagoJacobo Limeres, DDS,PhD, Study director, Universidad de Santiago (Grupo OMEQUI-2117)Javier Alvarez, MD,DDS, Principal investigator, Universidad de Santiago (Grupo OMEQUI-2117)Javier F Feijoo, MD,DDS,PhD, Principal investigator, Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de SantiagoMarcio Diniz, DDS,PhD, Principal investigator, Universidad de Santiago (Grupo OMEQUI-2117)Mercedes Outumuro, DDS,PhD, Principal investigator, Universidad de Santiago (Grupo OMEQUI-2117)Juan Medina, MD,Anest,PhD, Principal investigator, Hospital Clínico Universitario de SantiagoMiguel Castro, MD,DDS, PhD, Principal investigator, Universidad de Santiago (Grupo OMEQUI-2117)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115776
- Sponsor's protocol ID
- PGIDIT05PXIB92501PR
- Status last verified
- May 2015
- First submitted
- 8 Apr 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tomas I, Alvarez M, Limeres J, Potel C, Medina J, Diz P. Prevalence, duration and aetiology of bacteraemia following dental extractions. Oral Dis. 2007 Jan;13(1):56-62. doi: 10.1111/j.1601-0825.2006.01247.x.
PubMed 17241431Tomas I, Pereira F, Llucian R, Poveda R, Diz P, Bagan JV. Prevalence of bacteraemia following third molar surgery. Oral Dis. 2008 Jan;14(1):89-94. doi: 10.1111/j.1601-0825.2006.01359.x.
PubMed 18173454Valdes 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 18477269Pineiro 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 20701619Tomas I, Diz P, Tobias A, Scully C, Donos N. Periodontal health status and bacteraemia from daily oral activities: systematic review/meta-analysis. J Clin Periodontol. 2012 Mar;39(3):213-28. doi: 10.1111/j.1600-051X.2011.01784.x. Epub 2011 Sep 15.
PubMed 22092606Diz 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 16940094Diz Dios P. Infective endocarditis prophylaxis. Oral Dis. 2014 May;20(4):325-8. doi: 10.1111/odi.12221. Epub 2014 Jan 13.
PubMed 24373017Limeres 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
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures
- ClinicalTrials.gov ID
- NCT02115776
- Acronym / sponsor ID
- PGIDIT05PXIB92501PR
- Conditions
- Bacteremia
- Keywords
- bacteremia, prophylaxis, antibiotics, dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Hospital Clinico Universitario de Santiago
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a chlorhexidine mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental extractions.
The study hypothesis is that an antimicrobial regimen with amoxicillin-clavulanate will show higher effectiveness in reducing the prevalence and duration of bacteremia following dental extractions, than that achieved with the classical amoxicillin regimen.
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 amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a CHX mouthwash (AMX-CLV-CHX) 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, CHX or AMX-CLV; any type of congenital or acquired immunodeficiency; or any known risk factor for bacterial endocarditis. By applying these criteria, 200 patients will be selected and will be randomly distributed into 5 study groups: control group (receiving no prophylaxis), AMX group (receiving 2 g AMX i.v.), AMX-CLV group (receiving 1000/200mg AMX-CLV i.v.), CHX group (receiving a single 0.2% CHX mouthwash for 30 seconds), and AMX-CLV-CHX group (receiving 1000/200mg AMX-CLV i.v. and a single 0.2% CHX mouthwash for 30 seconds).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receiving no prophylaxis |
| Amoxicillin | Active comparator | Drug: AmoxicillinReceiving 2 g Amoxicillin intravenously before any dental manipulation and following endotracheal intubation |
| Amoxicillin-Potassium Clavulanate | Experimental | Drug: Amoxicillin-Potassium ClavulanateReceiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. before any dental manipulation and following endotracheal intubation |
| Chlorhexidine (CHX) | Active comparator | Drug: ChlorhexidineReceiving a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation |
| Amoxicillin-Potassium Clavulanate-CHX | Experimental | Drug: Amoxicillin-Potassium Clavulanate, Drug: ChlorhexidineReceiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. and a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin-Potassium ClavulanateAlso: AMOXICILINA + ACIDO CLAVULANICO SANDOZ EFG (code 600144)Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction | Drug | Amoxicillin-Potassium Clavulanate, Amoxicillin-Potassium Clavulanate-CHX |
| AmoxicillinAlso: AMOXICILINA SANDOZ EFG (code 694688)Administer Amoxicillin following endotracheal intubation prior to single tooth-extraction | Drug | Amoxicillin |
| ChlorhexidineAlso: Oraldine Perio (code 375725)Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction | Drug | Amoxicillin-Potassium Clavulanate-CHX, Chlorhexidine (CHX) |
Primary outcome
Number of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. 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 dental extraction
Percentage of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction
1 secondary outcome
Number of participants receiving a prophylactic dosage with amoxicillin i.v. (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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 17241431Tomas I, Alvarez M, Limeres J, Potel C, Medina J, Diz P. Prevalence, duration and aetiology of bacteraemia following dental extractions. Oral Dis. 2007 Jan;13(1):56-62. doi: 10.1111/j.1601-0825.2006.01247.x.
- Background: PubMed 18173454Tomas I, Pereira F, Llucian R, Poveda R, Diz P, Bagan JV. Prevalence of bacteraemia following third molar surgery. Oral Dis. 2008 Jan;14(1):89-94. doi: 10.1111/j.1601-0825.2006.01359.x.
- Background: PubMed 18477269Valdes 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.
- Background: PubMed 20701619Pineiro 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.
- Background: PubMed 22092606Tomas I, Diz P, Tobias A, Scully C, Donos N. Periodontal health status and bacteraemia from daily oral activities: systematic review/meta-analysis. J Clin Periodontol. 2012 Mar;39(3):213-28. doi: 10.1111/j.1600-051X.2011.01784.x. Epub 2011 Sep 15.
- Background: PubMed 16940094Diz 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.
- Background: PubMed 24373017Diz Dios P. Infective endocarditis prophylaxis. Oral Dis. 2014 May;20(4):325-8. doi: 10.1111/odi.12221. Epub 2014 Jan 13.
- Derived from this study: PubMed 27029851Limeres 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Diz, MD,DDS,PhD study chair
Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de Santiago
Jacobo Limeres, DDS,PhD study director
Universidad de Santiago (Grupo OMEQUI-2117)
Javier Alvarez, MD,DDS principal investigator
Universidad de Santiago (Grupo OMEQUI-2117)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin-Potassium Clavulanate, Amoxicillin and Chlorhexidine in people with Bacteremia, 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: finished, as of the sponsor's last update on 27 May 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. 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 dental extraction). 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 NCT02115776, which also lists 8 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 27 May 2015.