Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis

Infective Endocarditis Clinical Trial

Official title:

Beta-lactam Pharmacokinetic Profiles in Patients With Infective Endocarditis

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02033421
• Other study ID #: IE-100-2014
• Secondary ID: IE-150-2014
• Status: Unknown status
• Phase: N/A
• First received: December 18, 2013
• Last updated: June 17, 2015
• Start date: December 2013
• Est. completion date: January 2016

Study information

• Verified date: June 2015
• Source: University of Aarhus
• Contact: Kristina Öbrink-Hansen, MD
• Phone: +45 26133705
• Email: krisoebr[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

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and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.

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admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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 The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion.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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted with infective endocarditis

• Treatment with Beta-lactam antibiotics

Exclusion Criteria:

• Under 18 years of age

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Locations

Country	Name	City	State
Denmark	Department of cardiology, Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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