CClinicalTrials.gg
Status unknownNCT02033421Updated Jun 18, 2015

Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis

An observational study in Infective Endocarditis, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-18.

Sponsored by University of Aarhus · Observational

The sponsor has not verified this record recently (last verified Jun 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

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and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.

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admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.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 The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion.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

02

Conditions studied

  • Infective Endocarditis

Keywords

  • Infective endocarditis
  • Therapeutic drug monitoring
03

In context

Endocarditis, Bacterial

85 studies on the registry are indexed under Endocarditis, Bacterial; 19 are open to participants now.

This study's planned enrollment of 40 is below the median of 196 across 46 observational studies indexed under Endocarditis, Bacterial.

Browse Endocarditis, Bacterial studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under 18 years of age
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Pharmacokinetics Beta-lactam antibiotics

    Patients with infective endocarditis treated with Beta-lactam antibiotics

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Once a week during antibiotic treatment, an expected average of 5 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of cardiology, Aarhus University Hospital
    Aarhus N, 8200, Denmark
    • Kristina Öbrink-Hansen, MD · Contact · krisoebr@rm.dk · +45 26133705
    • Henrik Wiggers, MD, D.Sc · Contact · henrwigg@rm.dk · +45 7845 2270
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02033421
Lead sponsor
University of Aarhus
Responsible party
Kristina Öbrink-Hansen (MD, ph.d.-student, University of Aarhus) — Principal investigator
First posted
Jan 10, 2014
Start date
Dec 2013
Primary completion
Nov 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Jun 18, 2015

Study contacts

Kristina Öbrink-Hansen, MD
Contact
krisoebr@rm.dk
+45 26133705
Henrik Wiggers, MD, D.Sc
Contact
henrwigg@rm.dk
+45 78453202
Henrik Wiggers, Md, D.Sc
principal investigator · Department of cardiology, Aarhus University hospital, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion