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Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis

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ClinicalTrials.gov Identifier: NCT02033421
Recruitment Status : Unknown
Verified June 2015 by Kristina Öbrink-Hansen, University of Aarhus.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
Kristina Öbrink-Hansen, University of Aarhus

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and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.

Condition or disease
Infective Endocarditis

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admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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 The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion.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


Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Beta-lactam Pharmacokinetic Profiles in Patients With Infective Endocarditis
Study Start Date : December 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Pharmacokinetics Beta-lactam antibiotics
Patients with infective endocarditis treated with Beta-lactam antibiotics



Primary Outcome Measures :
  1. Blood-plasma concentration of Beta-lactam antibiotics [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18 years of age

Information from the National Library of Medicine

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): NCT02033421


Contacts
Contact: Kristina Öbrink-Hansen, MD +45 26133705 krisoebr@rm.dk
Contact: Henrik Wiggers, MD, D.Sc +45 78453202 henrwigg@rm.dk

Locations
Denmark
Department of cardiology, Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Kristina Öbrink-Hansen, MD    +45 26133705    krisoebr@rm.dk   
Contact: Henrik Wiggers, MD, D.Sc    +45 7845 2270    henrwigg@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Henrik Wiggers, Md, D.Sc Department of cardiology, Aarhus University hospital, Denmark

Responsible Party: Kristina Öbrink-Hansen, MD, ph.d.-student, University of Aarhus
ClinicalTrials.gov Identifier: NCT02033421     History of Changes
Other Study ID Numbers: IE-100-2014
IE-150-2014
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by Kristina Öbrink-Hansen, University of Aarhus:
Infective endocarditis
Therapeutic drug monitoring

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection
Lactams
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents