Dose Optimization of Rivaroxaban Combined With Rifampicin

Recruiting

• Conditions: Infections

• Registration Number: NCT05658042
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-07-01
• Study First Submitted: 2022-11-27
• Study First Submitted QC: 2022-12-17
• Last Update Submitted: 2022-12-17
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasma concentration of rivaroxaban	2-4 hours and 12-16 hours after 2-5 days of continuous dosing for rivaroxaban	HPLC-MS/MS method

Secondary Outcome Measures

Name	Time	Method
incidence of adverse reactions	From admission to discharge, up to 3 week	Bleeding and anemia
effect indicator	From admission to discharge, up to 3 week	Activated Partial Thromboplastin Time and Prothrombin time

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China