Susceptibility changes among oral microorganisms following single dose antibiotic prophylaxis

Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
Changes in antibiotic susceptibility among oral commensal microflora following a single dose administration of amoxicillin
MedDRA version: 14.1Level: PTClassification code 10002791Term: Antimicrobial susceptibility testSystem Organ Class: 10022891 - Investigations

Registration Number: EUCTR2013-000405-23-SE

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Written informed consent
Healthy
Age 18-45
Understands the study procedure and speaks Swedish and/or English
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Taken antibiotics within the previous three months
Pregnant
Breast-feeding
Allergic against penicillin
Concomitantly participate in another medical product study
On any kind of medication, health food preparations or probiotics

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine quantitative and qualitative oral microflora alterations and the changes in antibiotic susceptibility among oral commensal microflora following a single dose administration of amoxicillin;Secondary Objective: Determine the concentration of amoxicillin in saliva following administration;Primary end point(s): Quantitative and qualitative changes in the oral microflora<br>Changes is susceptibility to amoxicillin among these commensals;Timepoint(s) of evaluation of this end point: Day 2, 5, 10, 17 and 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Concentration of amoxicillin in saliva after one dose administration of amoxicillin;Timepoint(s) of evaluation of this end point: Day 1, 2 and 5