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Susceptibility changes among oral microorganisms following single dose antibiotic prophylaxis

Susceptibility changes among oral microorganisms following single dose antibiotic prophylaxis - Amoxicillin

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-000405-23-SE
Enrollment
Unknown
Registered
2013-04-05
Start date
2013-06-12
Completion date
Unknown
Last updated
2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Changes in antibiotic susceptibility among oral commensal microflora following a single dose administration of amoxicillin MedDRA version: 14.1 Level: PT Classification code 10002791 Term: Antimicrobial susceptibility test System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Amoxicillin Sandoz Product Name: Amoxicillin Product Code: J01CA04 Pharmaceutical Form: Tablet INN or Proposed INN: 81030-75-3 CAS Number: 26787-78-0 Other descriptive name: AMOXICILLIN TR

Sponsors

Karolinska University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 Changes is susceptibility to amoxicillin among these commensals;Timepoint(s) of evaluation of this end point: Day 2, 5, 10, 17 and 24—

Secondary

MeasureTime frame
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—

Countries

Sweden

Contacts

Public ContactBodil Lund

Karolinska University Hospital

bodil.lund@ki.se+46085858 39 55

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026