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InfectionsNCT05658042

Dose Optimization of Rivaroxaban Combined With Rifampicin

An observational study of Infections, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infections
How many people
80 participants
Where
1 siteChina
Study dates
1 Jul 2022to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: hospitalized patients

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Ruijuan Xu contact

+8613851502360

jean0129@163.com

China1 site, 1 recruiting

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

    Nanjing, Jiangsu

    Ruijuan Xu, +8613851502360, jean0129@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Infections
Keywords
periprosthetic infection, rivaroxaban
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05658042
Study groupRoleWhat they receive
rivaroxaban 10mg qdnonintervention
rivaroxaban 10mg qd+rifampicinnonintervention
rivaroxaban 20mg qd+rifampicinnonintervention
rivaroxaban 15mg bid+rifampicinnonintervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. plasma concentration of rivaroxaban

    HPLC-MS/MS method

    Measured: 2-4 hours and 12-16 hours after 2-5 days of continuous dosing for rivaroxaban

Secondary outcomes (2)

  1. incidence of adverse reactions

    Bleeding and anemia

    Measured: From admission to discharge, up to 3 week

  2. effect indicator

    Activated Partial Thromboplastin Time and Prothrombin time

    Measured: From admission to discharge, up to 3 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2022
  2. Study start1 Jul 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05658042
Sponsor's protocol ID
2022-LCYJ-PY-41
Status last verified
Mar 2022
First submitted
27 Nov 2022
Last updated
20 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Falck-Ytter Y, Francis CW, Johanson NA, Curley C, Dahl OE, Schulman S, Ortel TL, Pauker SG, Colwell CW Jr. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e278S-e325S. doi: 10.1378/chest.11-2404.

    PubMed 22315265

  • Gnoth MJ, Buetehorn U, Muenster U, Schwarz T, Sandmann S. In vitro and in vivo P-glycoprotein transport characteristics of rivaroxaban. J Pharmacol Exp Ther. 2011 Jul;338(1):372-80. doi: 10.1124/jpet.111.180240. Epub 2011 Apr 22.

    PubMed 21515813

  • Lang D, Freudenberger C, Weinz C. In vitro metabolism of rivaroxaban, an oral, direct factor Xa inhibitor, in liver microsomes and hepatocytes of rats, dogs, and humans. Drug Metab Dispos. 2009 May;37(5):1046-55. doi: 10.1124/dmd.108.025551. Epub 2009 Feb 5.

    PubMed 19196846

  • Weinz C, Schwarz T, Kubitza D, Mueck W, Lang D. Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans. Drug Metab Dispos. 2009 May;37(5):1056-64. doi: 10.1124/dmd.108.025569. Epub 2009 Feb 5.

    PubMed 19196845

  • Osmon DR, Berbari EF, Berendt AR, Lew D, Zimmerli W, Steckelberg JM, Rao N, Hanssen A, Wilson WR; Infectious Diseases Society of America. Diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jan;56(1):e1-e25. doi: 10.1093/cid/cis803. Epub 2012 Dec 6.

    PubMed 23223583

  • Vakkalagadda B, Frost C, Byon W, Boyd RA, Wang J, Zhang D, Yu Z, Dias C, Shenker A, LaCreta F. Effect of Rifampin on the Pharmacokinetics of Apixaban, an Oral Direct Inhibitor of Factor Xa. Am J Cardiovasc Drugs. 2016 Apr;16(2):119-27. doi: 10.1007/s40256-015-0157-9.

    PubMed 26749408

  • Altena R, van Roon E, Folkeringa R, de Wit H, Hoogendoorn M. Clinical challenges related to novel oral anticoagulants: drug-drug interactions and monitoring. Haematologica. 2014 Feb;99(2):e26-7. doi: 10.3324/haematol.2013.097287. No abstract available.

    PubMed 24497568

  • Becerra AF, Amuchastegui T, Tabares AH. Decreased Rivaroxaban Levels in a Patient with Cerebral Vein Thrombosis Receiving Phenytoin. Case Rep Hematol. 2017;2017:4760612. doi: 10.1155/2017/4760612. Epub 2017 Aug 10.

    PubMed 28875044

  • Mueck W, Borris LC, Dahl OE, Haas S, Huisman MV, Kakkar AK, Kalebo P, Muelhofer E, Misselwitz F, Eriksson BI. Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Haemost. 2008 Sep;100(3):453-61.

    PubMed 18766262

  • Wyse DG. Targeted Therapeutic Drug Monitoring for Direct Oral Anticoagulants: What Is Its Potential Place and Can It Limit Black Swan Events? Can J Cardiol. 2018 Nov;34(11):1393-1395. doi: 10.1016/j.cjca.2018.08.006. Epub 2018 Aug 9. No abstract available.

    PubMed 30404744

  • Bernier M, Lancrerot SL, Parassol N, Lavrut T, Viotti J, Rocher F, Drici MD. Therapeutic Drug Monitoring of Direct Oral Anticoagulants May Increase Their Benefit-Risk Ratio. J Cardiovasc Pharmacol. 2020 Oct;76(4):472-477. doi: 10.1097/FJC.0000000000000870.

    PubMed 33030858

  • Min JS, Bae SK. Prediction of drug-drug interaction potential using physiologically based pharmacokinetic modeling. Arch Pharm Res. 2017 Dec;40(12):1356-1379. doi: 10.1007/s12272-017-0976-0. Epub 2017 Oct 27.

    PubMed 29079968

Questions about this trial

What is this clinical trial studying?

An observational study of Infections, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ruijuan Xu (+8613851502360, jean0129@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

plasma concentration of rivaroxaban (time frame: 2-4 hours and 12-16 hours after 2-5 days of continuous dosing for rivaroxaban). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05658042, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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