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NCT Number: NCT07313215

Rifampin-combined Antibiotic Therapy for Staphylococcal PJI

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.

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Key information

Conditions

Periprosthetic Joint Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location status: Recruiting

Location contact

Xinyu Fang, MD

CONTACT

[email protected]

86+18084768503

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifampicin (R)

Drug

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 outcomes

  1. The clearance rate of infection, calculated by the formula

    Time frame: 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

  2. Adverse events related to PJI

    Time frame: Two years postoperatively

Secondary outcomes

  1. Postoperative functional score

    Time frame: Two years postoperatively

  2. 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

  3. The incidence of antibiotic complications

    Time frame: Two years postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Xinyu Fang, MD

CONTACT

[email protected]

86+18084768503

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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