Betalactam Pharmacokinetics in Endocarditis Patients

Recruiting now

Conditions studied: Infective Endocarditis

In brief

Infectious endocarditis (IE) is associated with mortality rates of 10-12%. Adequate antibiotic therapy is crucial for survival and is administered in high doses due to the severity of the disease. In most cases, beta-lactam antibiotics (e.g. ampicillin, penicillin G, cefotaxime or cloxacillin) are employed. A number of patient characteristics, such as age, body weight, and renal function) influence the pharmacokinetics of these drugs. Yet, the interindividual variability is poorly understood meaning that a large proportion of patients are at risk of subtherapeutic or excessive drug concentrations that might result in treatment failure or side effects, respectively. In the present study, data will be collected on antibiotic concentrations in patients treated with beta-lactams for infectious endocarditis as well as patient characteristics and treatment outcomes. A mathematical model will be developed to determine which patient factors determine drug pharmacokinetics. Based on this model, predictions will be made by mathematical simulations on which dosing regimens are optimal for individual patients to ensure therapeutic and non-toxic drug concentrations. In total, 150 patients will be included at four University Hospitals in Sweden; Uppsala University Hospital, Sahlgrenska University Hospital in Gothenburg, Skåne University Hospital in Lund and Karolinska University Hospital in Stockholm. Following informed consent to participate blood samples will be collected at 6 time-points during a dose interval and then at 3 time-points weekly during the full treatment episode (maximum 6 weeks).

Key facts

Study ID

NCT04647331

Run by

Uppsala University

People needed

150

Starts

2021-06-01

Expected to finish

2025-12-31

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• <18 years of age
• Ongoing dialysis

Where it is running

• Skåne University Hospital — Lund, Sweden (enrolling)
• Uppsala University Hospital — Uppsala, Sweden (enrolling)
• Sahlgrenska University Hospital — Gothenburg, Sweden
• Karolinska University Hospital — Stockholm, Sweden

Full record on ClinicalTrials.gov

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