Dose Optimization of Rivaroxaban Combined With Rifampicin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapeutic Drug Monitoring Combined With Quantitative Pharmacology for Dose Optimization of Rivaroxaban in Combination With Rifampicin in Patients With Periprosthetic Joint Infection

Conditions
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Infections

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rivaroxaban 10mg qd<br>nonintervention | |
| rivaroxaban 10mg qd+rifampicin<br>nonintervention | |
| rivaroxaban 20mg qd+rifampicin<br>nonintervention | |
| rivaroxaban 15mg bid+rifampicin<br>nonintervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentration of rivaroxaban | HPLC-MS/MS method | 2-4 hours and 12-16 hours after 2-5 days of continuous dosing for rivaroxaban | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse reactions | Bleeding and anemia | From admission to discharge, up to 3 week | 
| effect indicator | Activated Partial Thromboplastin Time and Prothrombin time | From admission to discharge, up to 3 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periprosthetic infection, rivaroxaban