Betalactam Pharmacokinetics in Endocarditis Patients

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
ACTIVE_NOT_RECRUITING
Gothenburg
Skåne University Hospital
RECRUITING
Lund
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Thomas Tängdén, MD, Phd
thomas.grenholm.tangden@medsci.uu.se
+46708370323
Backup
Lisa Faxén, MD
lisa.faxen@medsci.uu.se
+46768721806
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Related Therapeutic Areas
Sponsors
Leads: Uppsala University

This content was sourced from clinicaltrials.gov