Dose Optimization of Rivaroxaban Combined With Rifampicin

December 17, 2022 updated by: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospitalized patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
rivaroxaban 10mg qd
nonintervention
rivaroxaban 10mg qd+rifampicin
nonintervention
rivaroxaban 20mg qd+rifampicin
nonintervention
rivaroxaban 15mg bid+rifampicin
nonintervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma concentration of rivaroxaban
Time Frame: 2-4 hours and 12-16 hours after 2-5 days of continuous dosing for 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
Time Frame: From admission to discharge, up to 3 week
Bleeding and anemia
From admission to discharge, up to 3 week
effect indicator
Time Frame: From admission to discharge, up to 3 week
Activated Partial Thromboplastin Time and Prothrombin time
From admission to discharge, up to 3 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Study Director: Ruijuan Xu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

November 27, 2022

First Submitted That Met QC Criteria

December 17, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-LCYJ-PY-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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