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

This study has been terminated.
(The trial was stopped earlier than planned because of the slow accrual rate.)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00764062
First received: September 30, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 30, 2008
September 30, 2008
September 2005
October 2007   (final data collection date for primary outcome measure)
Susceptibility to amoxicillin of oral streptococci [ Time Frame: at day 0, day 9 and day 30. ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Non-inferiority of clinical efficacy [ Time Frame: at day 9 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Amoxicillin Susceptibility of Oral Streptococci After a 3-Day or a 7-Day Amoxicillin Therapy
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Odontogenic Infection
Drug: Amoxicillin
Amoxicillin :drug
Other Name: Amoxicillin
  • Experimental: 1
    7-day amoxicillin treatment (1g per os twice daily)
    Intervention: Drug: Amoxicillin
  • Active Comparator: 2
    3-day amoxicillin (1g per os twice daily) + 4-day placebo treatment (1g per os twice daily)
    Intervention: Drug: Amoxicillin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
81
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00764062
P040408
No
Valérie MILLUL, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Hélène CHARDIN, DD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP