NCT00764062

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Last Updated

October 1, 2008

Status Verified

September 1, 2008

Enrollment Period

2.1 years

First QC Date

September 30, 2008

Last Update Submit

September 30, 2008

Conditions

Odontogenic Infection

Keywords

AmoxicillinDrug resistance, microbialStreptococcusSurgery, oral

Outcome Measures

Primary Outcomes (1)

  • Susceptibility to amoxicillin of oral streptococci

    at day 0, day 9 and day 30.

Secondary Outcomes (1)

  • Non-inferiority of clinical efficacy

    at day 9

Study Arms (2)

1

EXPERIMENTAL

7-day amoxicillin treatment (1g per os twice daily)

Drug: Amoxicillin

2

ACTIVE COMPARATOR

3-day amoxicillin (1g per os twice daily) + 4-day placebo treatment (1g per os twice daily)

Drug: Amoxicillin

Interventions

AmoxicillinDRUG

Amoxicillin :drug

12

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris

Paris, 75000, France

Location

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hélène CHARDIN, DD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

September 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

October 1, 2008

Record last verified: 2008-09

Locations

FR(1)