Clinical trial NCT02033421: Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis
Official title: Beta-lactam Pharmacokinetic Profiles in Patients With Infective Endocarditis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infective Endocarditis
Keywords: Infective endocarditis
Therapeutic drug monitoring
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted with infective endocarditis at the Department of Cardiology, Aarhus University Hospital, Denmark, treated with beta-lactam antibiotics.

Brief summary: 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and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.

Detailed description: 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admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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 The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion.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.

Eligibility criteria: Inclusion Criteria:

* Patients admitted with infective endocarditis
* Treatment with Beta-lactam antibiotics

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Blood-plasma concentration of Beta-lactam antibiotics
timeFrame: Once a week during antibiotic treatment, an expected average of 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of cardiology, Aarhus University Hospital
Study officials:
affiliation: Department of cardiology, Aarhus University hospital, Denmark
name: Henrik Wiggers, Md, D.Sc
role: PRINCIPAL_INVESTIGATOR
References: