Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis

NCT ID: NCT02033421

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-01-31

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and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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 The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion.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

Conditions

Infective Endocarditis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Pharmacokinetics Beta-lactam antibiotics

Patients with infective endocarditis treated with Beta-lactam antibiotics

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Under 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Kristina Öbrink-Hansen

MD, ph.d.-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henrik Wiggers, Md, D.Sc

Role: PRINCIPAL_INVESTIGATOR

Department of cardiology, Aarhus University hospital, Denmark

Locations

Department of cardiology, Aarhus University Hospital

Aarhus N, Denmark, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Kristina Öbrink-Hansen, MD

Role: CONTACT

krisoebr@rm.dk

+45 26133705

Henrik Wiggers, MD, D.Sc

Role: CONTACT

henrwigg@rm.dk

+45 78453202

Facility Contacts

Kristina Öbrink-Hansen, MD

Role: primary

krisoebr@rm.dk

+45 26133705

Henrik Wiggers, MD, D.Sc

Role: backup

henrwigg@rm.dk

+45 7845 2270

Other Identifiers

IE-150-2014

Identifier Type: -

Identifier Source: secondary_id

IE-100-2014

Identifier Type: -

Identifier Source: org_study_id