Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
---|---|
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00764062 |
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.
Condition | Intervention | Phase |
---|---|---|
Odontogenic Infection |
Drug: Amoxicillin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety 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 |
Enrollment: | 81 |
Study Start Date: | September 2005 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
7-day amoxicillin treatment (1g per os twice daily)
|
Drug: Amoxicillin
Amoxicillin :drug
|
2: Active Comparator
3-day amoxicillin (1g per os twice daily) + 4-day placebo treatment (1g per os twice daily)
|
Drug: Amoxicillin
Amoxicillin :drug
|
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Assistance Publique - Hôpitaux de Paris | |
Paris, France, 75000 |
Principal Investigator: | Hélène CHARDIN, DD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Valérie MILLUL ) |
Study ID Numbers: | P040408 |
Study First Received: | September 30, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00764062 |
Health Authority: | France: Ministry of Health |
Amoxicillin Drug resistance, microbial Streptococcus Surgery, oral |
Amoxicillin Disease Susceptibility Genetic Predisposition to Disease |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Infection Pharmacologic Actions |