Odontogenic InfectionPhase 4ODAMOXNCT00764062
Amoxicillin Susceptibility of Oral Streptococci After a 3-Day or a 7-Day Amoxicillin Therapy
A Phase 4 study testing Amoxicillin in people with Odontogenic Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Antibiotic resistance is a worldwide problem closely linked to antibiotic consumption. To limit the risk to select resistant bacteria, the rules of prescription are to use high doses and short durations of treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Odontogenic Infection
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Oct 2007
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- odontogenic infection requiring tooth extraction asociated with amoxicillin monotherapy
- good condition
- 18-60 years old
- written informed consent provided
Who cannot join
- antibiotic prophylactic treatment
- special infectious risk (immunodeficiency, diabetes..)
- pregnant or breastfeeding women
- amoxicillin contraindication
- antibiotic treatment during the lasts 45 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Short Antibiotic Therapy (3-Day) Versus Long Antibiotic Therapy (7-Day) in Odontology-Stomatology: Impact on the Resistance of Oral Streptococci
Antibiotic resistance is a worldwide problem closely linked to antibiotic consumption. To limit the risk to select resistant bacteria, the rules of prescription are to use high doses and short durations of treatment. The purpose of this study was to evaluate the interest to reduce amoxicillin treatment from 7 days to 3 days, in cases of odontogenic infection requiring the extraction of the tooth associated with amoxicillin monotherapy. The 3-day treatment will be compared to the classical 7-day treatment for clinical efficacy (pain, wound healing) and impact on the susceptibility of oral streptococci to amoxicillin.
Read the detailed description
Amoxicillin treatment starts the day of the inclusion in the study (day 0). Dentists and participants were blinded to treatment assignment for the duration of the study. The infected tooth was extracted 2 days after the beginning of the antibiotic treatment, and the post-operative follow-up was done 1 week after tooth extraction (day 9). An additional follow-up was done one month later (day 30).
Clinical parameters were collected one week after tooth extraction (day 9). Pain was evaluated by its intensity during the days following surgery (using an analog visual scale varying from 0 -no pain- to 10 -very intense pain-), and by the total amount (in mg) of paracetamol ingested. The infectious state was evaluated by local wound healing, regional adenopathy and fever. The wound healing score combined local inflammation and sensitivity, and the presence or absence of a blood clot.
The streptococci resistance was assessed at the patient-level by the proportion of patient with at least one resistant streptococcus, and at the streptococcus-level by the proportion of resistant streptococcus out of the total streptococci flora. Intermediate susceptibility to amoxicillin was defined as a minimum inhibitory concentration (MIC) of 0.5-16 mg/L; resistance was defined as an MIC greater than or equal to 16 mg/L.
- Conditions
- Odontogenic Infection
- Being tested
- Amoxicillin
- Keywords
- Amoxicillin, Drug resistance, microbial, Streptococcus, Surgery, oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Amoxicillin :drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 7-day amoxicillin treatment (1g per os twice daily) Receives: Drug: Amoxicillin |
| 2 | Active comparator | 3-day amoxicillin (1g per os twice daily) + 4-day placebo treatment (1g per os twice daily) Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Susceptibility to amoxicillin of oral streptococci
Measured: at day 0, day 9 and day 30.
Secondary outcomes (1)
Non-inferiority of clinical efficacy
Measured: at day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startSep 2005
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: The trial was stopped earlier than planned because of the slow accrual rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontogenic InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Hélène CHARDIN, DD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764062
- Sponsor's protocol ID
- P040408
- Acronym
- ODAMOX
- Status last verified
- Sep 2008
- First submitted
- 30 Sep 2008
- Last updated
- 1 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Short Antibiotic Therapy (3-Day) Versus Long Antibiotic Therapy (7-Day) in Odontology-Stomatology: Impact on the Resistance of Oral Streptococci
- ClinicalTrials.gov ID
- NCT00764062
- Acronym / sponsor ID
- ODAMOX / P040408
- Conditions
- Odontogenic Infection
- Keywords
- Amoxicillin, Drug resistance, microbial, Streptococcus, Surgery, oral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was stopped earlier than planned because of the slow accrual rate.
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 1 Oct 2008 (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.
Antibiotic resistance is a worldwide problem closely linked to antibiotic consumption. To limit the risk to select resistant bacteria, the rules of prescription are to use high doses and short durations of treatment. The purpose of this study was to evaluate the interest to reduce amoxicillin treatment from 7 days to 3 days, in cases of odontogenic infection requiring the extraction of the tooth associated with amoxicillin monotherapy. The 3-day treatment will be compared to the classical 7-day treatment for clinical efficacy (pain, wound healing) and impact on the susceptibility of oral streptococci to amoxicillin.
Detailed description
Amoxicillin treatment starts the day of the inclusion in the study (day 0). Dentists and participants were blinded to treatment assignment for the duration of the study. The infected tooth was extracted 2 days after the beginning of the antibiotic treatment, and the post-operative follow-up was done 1 week after tooth extraction (day 9). An additional follow-up was done one month later (day 30).
Clinical parameters were collected one week after tooth extraction (day 9). Pain was evaluated by its intensity during the days following surgery (using an analog visual scale varying from 0 -no pain- to 10 -very intense pain-), and by the total amount (in mg) of paracetamol ingested. The infectious state was evaluated by local wound healing, regional adenopathy and fever. The wound healing score combined local inflammation and sensitivity, and the presence or absence of a blood clot.
The streptococci resistance was assessed at the patient-level by the proportion of patient with at least one resistant streptococcus, and at the streptococcus-level by the proportion of resistant streptococcus out of the total streptococci flora. Intermediate susceptibility to amoxicillin was defined as a minimum inhibitory concentration (MIC) of 0.5-16 mg/L; resistance was defined as an MIC greater than or equal to 16 mg/L.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Amoxicillin7-day amoxicillin treatment (1g per os twice daily) |
| 2 | Active comparator | Drug: Amoxicillin3-day amoxicillin (1g per os twice daily) + 4-day placebo treatment (1g per os twice daily) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- odontogenic infection requiring tooth extraction asociated with amoxicillin monotherapy
- good condition
- 18-60 years old
- written informed consent provided
Key exclusion criteria (5 listed)
- antibiotic prophylactic treatment
- special infectious risk (immunodeficiency, diabetes..)
- pregnant or breastfeeding women
- amoxicillin contraindication
- antibiotic treatment during the lasts 45 days
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 |
|---|---|---|
| AmoxicillinAmoxicillin :drug | Drug | 1, 2 |
Primary outcome
Susceptibility to amoxicillin of oral streptococci
Time frame: at day 0, day 9 and day 30.
1 secondary outcome
Non-inferiority of clinical efficacy
Time frame: at day 9
Results and safety
The study was stopped early (reason given: The trial was stopped earlier than planned because of the slow accrual rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2008.
Related trials for Odontogenic Infection
Not yet recruiting
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Recruiting
Single-step Functional Sinus Endoscopy and Transoral Surgery
Maxillary Sinusitis
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.
Hélène CHARDIN, DD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin in people with Odontogenic Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 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 1 Oct 2008. 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 France. 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: The trial was stopped earlier than planned because of the slow accrual rate.). 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?
Susceptibility to amoxicillin of oral streptococci (time frame: at day 0, day 9 and day 30.). 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 1 Oct 2008.