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Antibiotic Prophylaxis - Amoxicillin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829529
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Bodil Lund, Karolinska University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Amoxicillin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis
Study Start Date : September 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Amoxicillin
All subjects receive one dose of 2 g Amoxicillin
Drug: Amoxicillin
Amoxicillin
Other Name: Amoxicillin, Sandoz, 1 g tablet




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Concentration of amoxicillin in saliva after one dose administration of amoxicillin [ Time Frame: Day 1, 2, 5 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829529


Locations
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Sweden
Karolinska University Hospital. Department of Dental Medicine
Stockholm, Huddinge, Sweden, SE-141 86
Sponsors and Collaborators
Bodil Lund
Investigators
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Principal Investigator: Margareta Hultin, Dentist Department of Dental Medicine, Karolinska Institute
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Responsible Party: Bodil Lund, Assoc. professor, Dentist, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01829529    
Other Study ID Numbers: 2013-000405-23
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Keywords provided by Bodil Lund, Karolinska University Hospital:
Antibiotic prophylaxis
Additional relevant MeSH terms:
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Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents