Antibiotic Prophylaxis - Amoxicillin

NCT ID: NCT01829529

Last Updated: 2016-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Amoxicillin

All subjects receive one dose of 2 g Amoxicillin

Group Type EXPERIMENTAL

Amoxicillin

Intervention Type DRUG

Amoxicillin

Interventions

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Amoxicillin

Amoxicillin

Intervention Type DRUG

Other Intervention Names

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Amoxicillin, Sandoz, 1 g tablet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bodil Lund

OTHER

Sponsor Role lead

Responsible Party

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Bodil Lund

Assoc. professor, Dentist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Margareta Hultin, Dentist

Role: PRINCIPAL_INVESTIGATOR

Department of Dental Medicine, Karolinska Institute

Locations

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Karolinska University Hospital. Department of Dental Medicine

Stockholm, Huddinge, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2013-000405-23

Identifier Type: -

Identifier Source: org_study_id

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