Rifampin-combined Antibiotic Therapy for Staphylococcal PJI

NCT07313215 | Recruiting

• 1 other identifier: MRCTA, ECFAH of FMU[2024]821-1
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periprosthetic Joint Infection

Keywords

Periprosthetic Joint Infection; Debride ment, antibiotics, and implant retention; Revision

Outcome Measures

Primary Outcomes (2)

• The clearance rate of infection, calculated by the formula

  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

  two years postoperatively

• Adverse events related to PJI

  Two years postoperatively

Secondary Outcomes (3)

• Postoperative functional score

  Two years postoperatively

• The rate of prosthesis loosening after surgery, the revision rate, and the proportion of prostheses that need to be removed

  Two years postoperatively

• The incidence of antibiotic complications

  Two years postoperatively

Study Arms (2)

rifampicin combined with antibiotic treatment group

EXPERIMENTAL

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

Drug: Rifampicin (R)

antibiotic treatment group

ACTIVE COMPARATOR

In the "antibiotic treatment" group, conventional antibiotics alone are used for treatment

Drug: Rifampicin (R)

Interventions

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

antibiotic treatment group; rifampicin combined with antibiotic treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Interventions

Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Wenming Zhang, MD

  First Affiliated Hospital of Fujian Medical University

  STUDY DIRECTOR

Central Study Contacts

Xinyu Fang, MD

CONTACT

86+18084768503; fangxinyu0417@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 18, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)