Antibiotic Prophylaxis - Amoxicillin

September 1, 2016 updated by: Bodil Lund

Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis

The hypothesis of the present study is that quantitative and qualitative oral microflora alterations and changes in antibiotic susceptibility among oral commensal microflora will occur following a single dose administration of amoxicillin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 33 healthy volunteers, 16 males and 17 females, will be included. Written informed consent will be obtained from all participants.

Subjects will be excluded if they have taken antibiotics within the previous three months, are pregnant, breast-feeding or allergic against penicillin.

The participants will be given a single dose of 2 g amoxicillin. Saliva samples will be collected before administration of antibiotics (day 1) and on day 2, 5, 10, 17 and 24. Un-stimulated saliva will be accumulated in a plastic container. Concentration of amoxicillin in saliva will be measured on day 1, 2 and 5. Samples will be used for the determination of antibiotic concentration. Analyses of the sensitivities to amoxicillin and some other clinically relevant antibiotic compounds will also be performed.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Huddinge
      • Stockholm, Huddinge, Sweden, SE-141 86
        • Karolinska University Hospital. Department of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Healthy
  • Age 18-45
  • Understands the study procedure and speaks Swedish and/or English

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Amoxicillin
All subjects receive one dose of 2 g Amoxicillin
Drug: Amoxicillin
Amoxicillin
Other Names:
  • Amoxicillin, Sandoz, 1 g tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.
Time Frame: Day 1, 2, 5, 10, 17 and 24
Day 1, 2, 5, 10, 17 and 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentration of amoxicillin in saliva after one dose administration of amoxicillin
Time Frame: Day 1, 2, 5
Day 1, 2, 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bodil Lund

Investigators

  • Principal Investigator: Margareta Hultin, Dentist, Department of Dental Medicine, Karolinska Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (ESTIMATE)

April 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-000405-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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