Amoxicillin Susceptibility of Oral Streptococci After a 3-Day or a 7-Day Amoxicillin Therapy (ODAMOX)
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|ClinicalTrials.gov Identifier: NCT00764062|
Recruitment Status : Terminated (The trial was stopped earlier than planned because of the slow accrual rate.)
First Posted : October 1, 2008
Last Update Posted : October 1, 2008
|Condition or disease||Intervention/treatment||Phase|
|Odontogenic Infection||Drug: Amoxicillin||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
7-day amoxicillin treatment (1g per os twice daily)
Active Comparator: 2
3-day amoxicillin (1g per os twice daily) + 4-day placebo treatment (1g per os twice daily)
- Susceptibility to amoxicillin of oral streptococci [ Time Frame: at day 0, day 9 and day 30. ]
- Non-inferiority of clinical efficacy [ Time Frame: at day 9 ]
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): NCT00764062
|Assistance Publique - Hôpitaux de Paris|
|Paris, France, 75000|
|Principal Investigator:||Hélène CHARDIN, DD, PhD||Assistance Publique - Hôpitaux de Paris|