Dose Optimization of Rivaroxaban Combined With Rifampicin

Last updated: December 17, 2022
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05658042
2022-LCYJ-PY-41
  • Ages > 18
  • All Genders

Study 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

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

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-relatedbleeding 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 ormemory disorders)
  • Patients discontinued without meeting study target days
  • Patients with severe renal insufficiency (creatinine clearance rate < 30ml / min)

Study Design

Total Participants: 80
Study Start date:
July 01, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu
    China

    Active - Recruiting

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