Rifampin-combined Antibiotic Therapy for Staphylococcal PJI

Official title

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

Overview

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.

Detailed description

This study aims to evaluate the efficacy and safety of combined rifampicin for antibiotic treatment in patients with PJI after surgical treatment Sex. The research subjects were PJI patients with staphylococcus as the pathogen. After receiving DAIR treatment, they were screened and enrolled according to strict inclusion and exclusion criteria and randomly assigned to the rifampicin combined with antibiotic treatment group or the conventional antibiotic treatment group only. Then, systematic follow-up was conducted on the patients. Regularly assess its safety indicators such as the recurrence rate of infection, inflammatory indicators, prosthesis function recovery and drug side effects. The data will be entered through a unified recording system and patients who do not meet the research design will be excluded according to the predetermined exit criteria. After the follow-up, the data were summarized and analyzed, with a focus on examining the differences in the efficacy and safety of rifampicin combined therapy in controlling PJI infection. Through this study, we hope to clarify the efficacy and safety of rifampicin combined with antibiotics in PJI treatment, thereby providing a reference basis for the optimization of antibiotic regimens for PJI.

Interventions

• Drug 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

Primary outcome measures

• The clearance rate of infection, calculated by the formula [Time frame: two years postoperatively]
• Adverse events related to PJI [Time frame: Two years postoperatively]

Secondary outcome measures (3)

• Postoperative functional score [Time frame: Two years postoperatively]
• The rate of prosthesis loosening after surgery, the revision rate, and the proportion of prostheses that need to be removed [Time frame: Two years postoperatively]
• The incidence of antibiotic complications [Time frame: Two years postoperatively]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Fujian Medical University — Fuzhou

Identifiers

NCT: NCT07313215 · MRCTA, ECFAH of FMU[2024]821-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗