Rifampin-combined Antibiotic Therapy for Staphylococcal PJI

Recruiting now · Not applicable

Conditions studied: Periprosthetic Joint Infection

In brief

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.

Key facts

Study ID

NCT07313215

Run by

First Affiliated Hospital of Fujian Medical University

People needed

428

Starts

2025-11-13

Expected to finish

2027-12-18

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)

Full record on ClinicalTrials.gov

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