HealthyPhase 3NCT01829529
Antibiotic Prophylaxis - Amoxicillin
A Phase 3 study testing Amoxicillin in people with Healthy, run by Bodil Lund at 1 site in Sweden.
Trial summary
The hypothesis of the present study is that quantitative and qualitative oral microflora alterations and changes in antibiotic susceptibility among oral commensal microflora will occur following a single dose administration of amoxicillin. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Jan 2016
- Phase
- Phase 3
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Healthy
- Age 18-45
- Understands the study procedure and speaks Swedish and/or English
Who cannot join
- Treatment with antibiotics within the previous three months
- Pregnant
- Breast-feeding
- Allergic against penicillin
- Concomitantly participate in another medical product study
- Treatment with any kind of medication, health food preparations or probiotics
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital. Department of Dental Medicine
Stockholm, Huddinge, SE-141 86
About this study
Official title: Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis
The hypothesis of the present study is that quantitative and qualitative oral microflora alterations and changes in antibiotic susceptibility among oral commensal microflora will occur following a single dose administration of amoxicillin.
Read the detailed description
A total of 33 healthy volunteers, 16 males and 17 females, will be included. Written informed consent will be obtained from all participants.
Subjects will be excluded if they have taken antibiotics within the previous three months, are pregnant, breast-feeding or allergic against penicillin.
The participants will be given a single dose of 2 g amoxicillin. Saliva samples will be collected before administration of antibiotics (day 1) and on day 2, 5, 10, 17 and 24. Un-stimulated saliva will be accumulated in a plastic container. Concentration of amoxicillin in saliva will be measured on day 1, 2 and 5. Samples will be used for the determination of antibiotic concentration. Analyses of the sensitivities to amoxicillin and some other clinically relevant antibiotic compounds will also be performed.
- Conditions
- Healthy
- Being tested
- Amoxicillin
- Keywords
- Antibiotic prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Amoxicillin, Sandoz, 1 g tablet
Amoxicillin
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Experimental | All subjects receive one dose of 2 g Amoxicillin Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.
Measured: Day 1, 2, 5, 10, 17 and 24
Secondary outcomes (1)
Concentration of amoxicillin in saliva after one dose administration of amoxicillin
Measured: Day 1, 2, 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bodil Lund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bodil Lund, Karolinska University Hospital
- Investigators
- Margareta Hultin, Dentist, Principal investigator, Department of Dental Medicine, Karolinska Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829529
- Sponsor's protocol ID
- 2013-000405-23
- Status last verified
- Sep 2016
- First submitted
- 9 Apr 2013
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis
- ClinicalTrials.gov ID
- NCT01829529
- Acronym / sponsor ID
- 2013-000405-23
- Conditions
- Healthy
- Keywords
- Antibiotic prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Bodil LundUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Apr 2013 (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 hypothesis of the present study is that quantitative and qualitative oral microflora alterations and changes in antibiotic susceptibility among oral commensal microflora will occur following a single dose administration of amoxicillin.
Detailed description
A total of 33 healthy volunteers, 16 males and 17 females, will be included. Written informed consent will be obtained from all participants.
Subjects will be excluded if they have taken antibiotics within the previous three months, are pregnant, breast-feeding or allergic against penicillin.
The participants will be given a single dose of 2 g amoxicillin. Saliva samples will be collected before administration of antibiotics (day 1) and on day 2, 5, 10, 17 and 24. Un-stimulated saliva will be accumulated in a plastic container. Concentration of amoxicillin in saliva will be measured on day 1, 2 and 5. Samples will be used for the determination of antibiotic concentration. Analyses of the sensitivities to amoxicillin and some other clinically relevant antibiotic compounds will also be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Experimental | Drug: AmoxicillinAll subjects receive one dose of 2 g Amoxicillin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent
- Healthy
- Age 18-45
- Understands the study procedure and speaks Swedish and/or English
Key exclusion criteria (6 listed)
- Treatment with antibiotics within the previous three months
- Pregnant
- Breast-feeding
- Allergic against penicillin
- Concomitantly participate in another medical product study
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 |
|---|---|---|
| AmoxicillinAlso: Amoxicillin, Sandoz, 1 g tabletAmoxicillin | Drug | Amoxicillin |
Primary outcome
Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.
Time frame: Day 1, 2, 5, 10, 17 and 24
1 secondary outcome
Concentration of amoxicillin in saliva after one dose administration of amoxicillin
Time frame: Day 1, 2, 5
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 2 Sep 2016.
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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.
Margareta Hultin, Dentist principal investigator
Department of Dental Medicine, Karolinska Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin in people with Healthy, run by Bodil Lund at 1 site in Sweden.
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 4 inclusion and 6 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 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals. (time frame: Day 1, 2, 5, 10, 17 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2016.