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Recruiting
NCT05658042
Dose Optimization of Rivaroxaban Combined With Rifampicin
Conditions: Infections
Sex: All
Ages: 18 Years – N/A
Enrollment: 80
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Location: China
Summary
The goal of this observational study is to learn about exposure levels of rivaroxaban at different doses in patients with prosthetic joint infection combined with the use of rifampicin.
Participants will be collected blood samples to determine rivaroxaban plasma concentration.
The main question it aims to answer is to predict the dose adjustment of rivaroxaban combined with the use of rifampin.
Eligibility Criteria
Inclusion Criteria:Patients aged>18 yearsThe diagnosis was periprosthetic infection after joint replacementOrthopedic operations such as revision of artificial joints, removal of prostheses, debridement, etc. for the treatment of periprosthetic infectionRivaroxaban was used to prevent deep vein thrombosis after operation.Exclusion Criteria:Patients allergic to any excipient in rivaroxaban, rifampicin or tabletsPatients with clinically significant active bleedingPatients with significant risk of bleedingPatients with liver disease with coagulation abnormalities and clinical-related bleeding risk, including patients with cirrhosis who reached Child Pugh C gradePregnant women and breastfeeding womenPatients taking combined drugs affecting rivaroxaban metabolismPatients who were unable or unwilling to cooperate with the study (Such as mental or memory disorders)Patients discontinued without meeting study target daysPatients with severe renal insufficiency (creatinine clearance rate < 30ml / min)
Source: ClinicalTrials.gov (NCT05658042). StuddyBuddy aggregates publicly available trial information.