Amoxicillin Susceptibility of Oral Streptococci After a 3-Day or a 7-Day Amoxicillin Therapy

Phase 4

Terminated

• Conditions: Odontogenic Infection
• Interventions: Drug: Amoxicillin

• Registration Number: NCT00764062
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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. 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 Timeline

• Study Start: 2005-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-09
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Last Update Submitted: 2008-09-30
• Study First Posted: 2008-10-01
• Last Update Posted: 2008-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• odontogenic infection requiring tooth extraction asociated with amoxicillin monotherapy
• good condition
• 18-60 years old
• written informed consent provided

Exclusion Criteria

• antibiotic prophylactic treatment
• special infectious risk (immunodeficiency, diabetes..)
• pregnant or breastfeeding women
• amoxicillin contraindication
• antibiotic treatment during the lasts 45 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Amoxicillin	7-day amoxicillin treatment (1g per os twice daily)
2	Amoxicillin	3-day amoxicillin (1g per os twice daily) + 4-day placebo treatment (1g per os twice daily)

Primary Outcome Measures

Name	Time	Method
Susceptibility to amoxicillin of oral streptococci	at day 0, day 9 and day 30.

Secondary Outcome Measures

Name	Time	Method
Non-inferiority of clinical efficacy	at day 9

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, France