Optimizing rivaroxaban doses for patients with joint infections
Therapeutic Drug Monitoring Combined With Quantitative Pharmacology for Dose Optimization of Rivaroxaban in Combination With Rifampicin in Patients With Periprosthetic Joint Infection
This study is testing how to adjust the dose of rivaroxaban for patients with joint infections who are also taking rifampicin to make sure they get the right amount of medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05658042 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the plasma concentration of rivaroxaban in patients with periprosthetic infections who are also receiving rifampicin. Blood samples will be collected to monitor rivaroxaban levels, and the data will be analyzed using statistical tests and pharmacokinetic models to suggest optimal dosing adjustments. The study does not interfere with standard clinical care and focuses on understanding how these medications interact in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years diagnosed with periprosthetic infections following joint replacement surgery who are prescribed rivaroxaban.
Not a fit: Patients with significant bleeding risks, liver disease, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective dosing strategies for rivaroxaban in patients with joint infections, potentially improving patient outcomes.
How similar studies have performed: While there is limited data on this specific combination, similar studies have explored anticoagulant dosing adjustments in various contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Nanjing, Jiangsu
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Ruijuan Xu
- Email: jean0129@163.com
- Phone: +8613851502360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.