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Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis

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University of Aarhus

Status

Unknown

Conditions

Infective Endocarditis

Study type

Observational

Funder types

Other

Identifiers

NCT02033421
IE-150-2014
IE-100-2014

Details and patient eligibility

About

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and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.

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admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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 The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion.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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Under 18 years of age

Trial design

40 participants in 1 patient group

Pharmacokinetics Beta-lactam antibiotics
Description:
Patients with infective endocarditis treated with Beta-lactam antibiotics

Trial contacts and locations

1

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Central trial contact

Henrik Wiggers, MD, D.Sc; Kristina Öbrink-Hansen, MD

Data sourced from clinicaltrials.gov

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