Rifampin-combined Antibiotic Therapy for Staphylococcal PJI

Condition(s) studied

Investigational drug(s) / intervention(s)

Rifampicin (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

Study 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

Primary outcome measure(s)

• The clearance rate of infection, calculated by the formula — two years postoperatively
  The number of subjects determined to have cleared the infection/the total number of subjects who completed the follow-up. Infection clearance is defined as the patient's (1) complete eradication of infection, wound healing, no fistula, no drainage, no pain, and no recurrence of the same strain of infection. (2) No reoperation intervention due to infection; (3) No deaths caused by PJI-related diseases such as sepsis and necrotizing fasciitis occurred
• Adverse events related to PJI — Two years postoperatively

Trial sites (1)

More First Affiliated Hospital of Fujian Medical University trials in China

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