Actively Recruiting
Betalactam Pharmacokinetics in Endocarditis Patients
Led by Uppsala University · Updated on 2025-12-17
150
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying infectious endocarditis (IE), a serious heart infection with a 10-12% mortality rate, to better understand how beta-lactam antibiotics behave in the body. These antibiotics, including ampicillin, penicillin G, cefotaxime, and cloxacillin, are given in high doses, but patient factors like age, weight, and kidney function affect how the drugs are processed, which may impact treatment success or side effects. The study collects detailed data from 150 patients treated with these antibiotics at four university hospitals in Sweden. Blood samples are taken frequently during the treatment period, including six samples within one dosing interval and additional samples weekly for up to six weeks. Patient information such as age, weight, gender, and routine biomarker results are also recorded. The goal is to develop a mathematical model predicting optimal dosing for individual patients. Participants provide informed consent and undergo regular blood sampling and monitoring of clinical outcomes, including treatment success and side effects. The study tracks various measures of drug levels in the blood and correlates them with patient characteristics and outcomes. Data is anonymized, securely stored, and analyzed to understand drug behavior and its relation to treatment effects and safety over the course of therapy and follow-up.
CONDITIONS
Brief Title
Betalactam Pharmacokinetics in Endocarditis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Verified or suspected left or right sided endocarditis in native or prosthetic valve
- Intravenous antibiotic therapy with either ampicillin, penicillin G, cefotaxime or cloxacillin
- Signed informed consent to participate in study
You will not qualify if you...
- Under 18 years of age
- Ongoing dialysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week from start of treatment
Participants receive intravenous beta-lactam antibiotics and have blood samples collected to determine drug concentrations and pharmacokinetic profiles. Patient characteristics and biomarkers are also monitored.
Multiple blood sampling visits within 1 week; weekly blood samples thereafter
Duration - Up to 12 months
Participants are observed for clinical outcomes, including treatment success, side effects, and complications for up to 12 months after therapy completion.
Follow-up assessments as per routine care
Trial Site Locations
Total: 4 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Active, Not Recruiting
2
Skåne University Hospital
Lund, Sweden
Actively Recruiting
3
Karolinska University Hospital
Stockholm, Sweden
Not Yet Recruiting
4
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
T
Thomas Tängdén, MD, Phd
L
Lisa Faxén, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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