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Dose Optimization of Rivaroxaban Combined With Rifampicin

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT05658042
Collaborator
(none)
80
Enrollment
1
Location
36
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Therapeutic Drug Monitoring Combined With Quantitative Pharmacology for Dose Optimization of Rivaroxaban in Combination With Rifampicin in Patients With Periprosthetic Joint Infection
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    rivaroxaban 10mg qd

    nonintervention
    rivaroxaban 10mg qd+rifampicin

    nonintervention
    rivaroxaban 20mg qd+rifampicin

    nonintervention
    rivaroxaban 15mg bid+rifampicin

    nonintervention

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. incidence of adverse reactions [From admission to discharge, up to 3 week]

      Bleeding and anemia

    2. effect indicator [From admission to discharge, up to 3 week]

      Activated Partial Thromboplastin Time and Prothrombin time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Nanjing Jiangsu China

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    ClinicalTrials.gov Identifier:
    NCT05658042
    Other Study ID Numbers:
    • 2022-LCYJ-PY-41
    First Posted:
    Dec 20, 2022
    Last Update Posted:
    Dec 20, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    periprosthetic infection
    rivaroxaban
    Additional relevant MeSH terms:
    Infections

    Study Results

    No Results Posted as of Dec 20, 2022