Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis

Beta-lactam Pharmacokinetic Profiles in Patients With Infective Endocarditis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02033421

Enrollment

Registered

2014-01-10

Start date

2013-12-31

Completion date

2016-01-31

Last updated

2015-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective Endocarditis

Keywords

Infective endocarditis, Therapeutic drug monitoring

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and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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 The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion.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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Under 18 years of age

Design outcomes

Primary

Measure	Time frame	Description
Blood-plasma concentration of Beta-lactam antibiotics	Once a week during antibiotic treatment, an expected average of 5 weeks	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.

Countries

Denmark

Contacts

Primary ContactKristina Öbrink-Hansen, MD

krisoebr@rm.dk+45 26133705

Backup ContactHenrik Wiggers, MD, D.Sc

henrwigg@rm.dk+45 78453202

Outcome results