Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis
The recommended length of antibiotic treatment to patients with infective endocarditis is 4-6 weeks. All patients receive the same dosis except for those with renal impairment who receive a smaller dose. For Beta-lactam antibiotics, a plasma concentration above the minimal inhibitory concentration (MIC) for at least 50% of the time in a dosing interval maximize bactericidal activity. To estimate the time for which the antibiotic concentration is above the MIC (T>MIC) and to see if there might be a relationship between the concentration of antibiotics and possible side-effects, toxicity and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Beta-lactam Pharmacokinetic Profiles in Patients With Infective Endocarditis|
- Blood-plasma concentration of Beta-lactam antibiotics [ Time Frame: Once a week during antibiotic treatment, an expected average of 5 weeks ] [ Designated as safety issue: No ]The first blood test will be withdrawn within a week after initiation of antibiotic therapy. The next blood test will be taken approximately 7 days after the first one and so forth once a week, until the termination of antibiotic treatment, an expected average of 5 weeks.
Biospecimen Retention: Samples With DNA
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Pharmacokinetics Beta-lactam antibiotics
Patients with infective endocarditis treated with Beta-lactam antibiotics
Comorbidity is common in patients admitted with infective endocarditis and this may effect the pharmacokinetics of antibiotics. The same dose of antibiotics may therefore result in different plasma concentrations in different patients, and this might influence possible side-effects, toxicity and treatment failure.
To investigate this further, all patients admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks. Beta-lactam is administered every 6th hour. The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion. There is no intervention in the study, the results are observational. The results will contribute to assess the efficacy and quality of the treatment and help evaluate whether plasma concentration of antibiotics should be taken as a routine blood test every week in patients with infective endocarditis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02033421
|Contact: Kristina Öbrink-Hansen, MD||+45 firstname.lastname@example.org|
|Contact: Henrik Wiggers, MD, D.Sc||+45 email@example.com|
|Department of cardiology, Aarhus University Hospital||Recruiting|
|Aarhus N, Denmark, 8200|
|Contact: Kristina Öbrink-Hansen, MD +45 26133705 firstname.lastname@example.org|
|Contact: Henrik Wiggers, MD, D.Sc +45 7845 2270 email@example.com|
|Principal Investigator:||Henrik Wiggers, Md, D.Sc||Department of cardiology, Aarhus University hospital, Denmark|