RecruitingNot ApplicableNCT07313215

Rifampin-combined Antibiotic Therapy for Staphylococcal PJI

The Efficacy and Complications of Rifampin-combined Antibiotic Therapy for Staphylococcal Periprosthetic Joint Infections（PJI）: A Multicenter, Randomized Controlled Trial

Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

428 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

Periprosthetic Joint Infection

Summary

This is a prospective, multicenter, randomized controlled study. Patients were evaluated through inclusion and exclusion criteria. Patients who meet the conditions will sign an informed consent form. After DAIR surgery, they will be treated with intravenous antibiotics for 1-2 weeks and then randomly assigned to one of the following two groups: Antibiotic treatment group: All enrolled patients will be treated with antibiotics (fluoroquinolones or linezolid) for 3 months based on the results of microbial culture and drug sensitivity after surgery. Rifampicin combined with antibiotics treatment group: In addition to the above-mentioned antibiotics, all enrolled patients were treated with rifampicin for 3 months after the operation. The infection control rates of the two groups were judged through at least 2-year follow-up after the operation.The study will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting parallel group randomised trials. Ethical approval will be obtained from each institution. Written informed consent will be obtained from all participants to ensure their voluntary participation and understanding of the study.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

Diagnosed as PJI according to the MSIS criteria
The pathogenic bacteria were identified as Staphylococcus through microbial culture and drug sensitivity tests were conducted
There are complete clinical data ④ Age under 80 years old, without serious complications or immunosuppressive status ⑤ The patient voluntarily participated in this study and was physically and mentally tolerant of the treatment process and various tests in this study. They have signed the informed consent form and passed the review of the ethics committees of all hospitals participating in this study

Exclusion Criteria3

Those with chronic inflammation in other parts of the body before the operation
Non-staphylococcal infection or mixed infection
The patient has other diseases that may affect the outcome, such as immune deficiency or liver and kidney dysfunction ④ Those with an expected lifespan of less than half a year ⑤ The researcher determined that the patient no longer met the criteria of this study due to compliance issues

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Interventions

DRUGRifampicin (R)

In the "rifampicin combined with antibiotic treatment" group, on the basis of conventional antibiotic treatment, rifampicin is taken orally for an additional three months. In the "antibiotic treatment" group, conventional antibiotics alone are used for treatment