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

Odontogenic Infection Clinical Trial

— ODAMOX  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00764062
• Other study ID #: P040408
• Status: Terminated
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: September 30, 2008
• Start date: September 2005
• Est. completion date: October 2007

Study information

• Verified date: September 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Odontogenic Infection

Intervention

Drug:
• Amoxicillin
Amoxicillin :drug

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Susceptibility to amoxicillin of oral streptococci		at day 0, day 9 and day 30.	Yes
Secondary	Non-inferiority of clinical efficacy		at day 9	Yes