Antibiotic Prophylaxis - Amoxicillin
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|ClinicalTrials.gov Identifier: NCT01829529|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Amoxicillin||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
All subjects receive one dose of 2 g Amoxicillin
Other Name: Amoxicillin, Sandoz, 1 g tablet
- 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 ]
- Concentration of amoxicillin in saliva after one dose administration of amoxicillin [ Time Frame: Day 1, 2, 5 ]
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
|Karolinska University Hospital. Department of Dental Medicine|
|Stockholm, Huddinge, Sweden, SE-141 86|
|Principal Investigator:||Margareta Hultin, Dentist||Department of Dental Medicine, Karolinska Institute|