Dose Optimization of Rivaroxaban Combined With Rifampicin

Nanjing University

Status

Enrolling

Conditions

Infections

Study type

Observational

Funder types

Other

Identifiers

NCT05658042

2022-LCYJ-PY-41

Details and patient eligibility

About

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.

Full description

This study is a prospective observational study and does not interfere with the normal clinical diagnosis and treatment process. In the case of patients with periprosthetic infection with or without rifampicin, the blood concentration of rivaroxaban was monitored, and the data were further predicted and analyzed by statistical tests and physiological pharmacokinetic models, and suggestions were made for dose optimization.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged>18 years
The diagnosis was periprosthetic infection after joint replacement
Orthopedic operations such as revision of artificial joints, removal of prostheses, debridement, etc. for the treatment of periprosthetic infection
Rivaroxaban was used to prevent deep vein thrombosis after operation.

Exclusion criteria

Patients allergic to any excipient in rivaroxaban, rifampicin or tablets
Patients with clinically significant active bleeding
Patients with significant risk of bleeding
Patients with liver disease with coagulation abnormalities and clinical-related bleeding risk, including patients with cirrhosis who reached Child Pugh C grade
Pregnant women and breastfeeding women
Patients taking combined drugs affecting rivaroxaban metabolism
Patients who were unable or unwilling to cooperate with the study (Such as mental or memory disorders)
Patients discontinued without meeting study target days
Patients with severe renal insufficiency (creatinine clearance rate < 30ml / min)