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
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Susceptibility to amoxicillin of oral streptococci [ Time Frame: at day 0, day 9 and day 30. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Non-inferiority of clinical efficacy [ Time Frame: at day 9 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Valérie MILLUL, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00764062     History of Changes
Other Study ID Numbers: P040408
Study First Received: September 30, 2008
Last Updated: September 30, 2008
Health Authority: France: Ministry of Health

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014