Antibiotic Prophylaxis - Amoxicillin

Healthy Clinical Trial

Official title:

Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829529
• Other study ID #: 2013-000405-23
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2013
• Last updated: September 1, 2016
• Start date: September 2013
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Amoxicillin
Amoxicillin

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital. Department of Dental Medicine	Stockholm	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Bodil Lund

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.		Day 1, 2, 5, 10, 17 and 24	No
Secondary	Concentration of amoxicillin in saliva after one dose administration of amoxicillin		Day 1, 2, 5	No