Pharmacokinetics of Beta-lactam in Patients With Infective Endocarditis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
Kristina Öbrink-Hansen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT02033421
First received: December 18, 2013
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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    The first blood test will be withdrawn within a week after initiation of antibiotic therapy.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 antibotic treatment, an expected average of 5 weeks.


Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pharmacokinetics Beta-lactam antibiotics
Patients with infective endocarditis treated with Beta-lactam antibiotics

Detailed Description:

Comorbidity is common in patients admitted with infective endocarditis and this might effect the pharmacokinetics of antibiotics. The same dose of antibiotics might 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 18, 2013
Last Updated: January 9, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014