NCT04647331 Betalactam Pharmacokinetics in Endocarditis Patients
| NCT ID | NCT04647331 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Infective Endocarditis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2021-06-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * \<18 years of age * Ongoing dialysis
Contact & Investigator
Thomas Tängdén, MD, Phd
PRINCIPAL INVESTIGATOR
Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT04647331 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infective Endocarditis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04647331 currently recruiting?
Yes, NCT04647331 is actively recruiting participants. Contact the research team at thomas.grenholm.tangden@medsci.uu.se for enrollment information.
Where is the NCT04647331 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Lund, Sweden, Stockholm, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT04647331 clinical trial?
NCT04647331 is sponsored by Uppsala University. The principal investigator is Thomas Tängdén, MD, Phd at Uppsala University Hospital. The trial plans to enroll 150 participants.