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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
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Odontogenic Infection Drug: Amoxicillin Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
7-day amoxicillin treatment (1g per os twice daily)
Drug: Amoxicillin
Amoxicillin :drug
Active Comparator: 2
3-day amoxicillin (1g per os twice daily) + 4-day placebo treatment (1g per os twice daily)
Drug: Amoxicillin
Amoxicillin :drug



Primary Outcome Measures :
  1. Susceptibility to amoxicillin of oral streptococci [ Time Frame: at day 0, day 9 and day 30. ]

Secondary Outcome Measures :
  1. Non-inferiority of clinical efficacy [ Time Frame: at day 9 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
France
Assistance Publique - Hôpitaux de Paris
Paris, France, 75000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Hélène CHARDIN, DD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Valérie MILLUL, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00764062     History of Changes
Other Study ID Numbers: P040408
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: October 1, 2008
Last Verified: September 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Amoxicillin
Drug resistance, microbial
Streptococcus
Surgery, oral

Additional relevant MeSH terms:
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents