Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis
Beta-lactam Pharmacokinetic Profiles in Patients With Infective Endocarditis
2 other identifiers
observational
40
1 country
1
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and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJune 18, 2015
June 1, 2015
1.9 years
December 18, 2013
June 17, 2015
Conditions
Keywords
Outcome Measures
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The first blood test will be withdrawn within a week after initiation of antibiotic therapy.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.
Once a week during antibiotic treatment, an expected average of 5 weeks
Study Arms (1)
Pharmacokinetics Beta-lactam antibiotics
Patients with infective endocarditis treated with Beta-lactam antibiotics
Eligibility Criteria
Patients admitted with infective endocarditis at the Department of Cardiology, Aarhus University Hospital, Denmark, treated with beta-lactam antibiotics.
You may qualify if:
- Patients admitted with infective endocarditis
- Treatment with Beta-lactam antibiotics
You may not qualify if:
- Under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of cardiology, Aarhus University Hospital
Aarhus N, Denmark, 8200, Denmark
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik Wiggers, Md, D.Sc
Department of cardiology, Aarhus University hospital, Denmark
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, ph.d.-student
Study Record Dates
First Submitted
December 18, 2013
First Posted
January 10, 2014
Study Start
December 1, 2013
Primary Completion
November 1, 2015
Study Completion
January 1, 2016
Last Updated
June 18, 2015
Record last verified: 2015-06