Adding rifampin to antibiotics after DAIR for staphylococcal periprosthetic joint infection
The Efficacy and Complications of Rifampin-combined Antibiotic Therapy for Staphylococcal Periprosthetic Joint Infections（PJI）: A Multicenter, Randomized Controlled Trial
This trial tests whether giving rifampicin in addition to standard antibiotics for adults with staphylococcal periprosthetic joint infection after DAIR improves long-term infection control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 428 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07313215 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized multicenter trial enrolling patients with Staphylococcus-confirmed periprosthetic joint infection treated with debridement, antibiotics, and implant retention (DAIR). After 1–2 weeks of intravenous antibiotics, participants are randomized to receive either a three-month oral antibiotic regimen (fluoroquinolones or linezolid guided by culture) alone or the same regimen plus rifampicin for three months. Outcomes include infection control rate with at least two years of follow-up, recurrence, inflammatory markers, prosthesis function recovery, and drug-related adverse events. The trial follows CONSORT reporting standards and uses a unified data recording system across sites.
Who should consider this trial
Good fit: Ideal candidates are adults under 80 with MSIS-confirmed PJI caused by Staphylococcus who have undergone DAIR, have sufficient clinical data, no major immunosuppression or organ dysfunction, and can consent and complete follow-up.
Not a fit: Patients with non-staphylococcal or mixed infections, chronic nonrelated inflammatory conditions, significant liver or kidney dysfunction, severe immunodeficiency, or short expected survival are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding rifampicin could lower infection recurrence and improve prosthesis retention and function in staphylococcal PJI patients.
How similar studies have performed: Previous randomized and observational studies have suggested rifampin can improve outcomes in staphylococcal prosthetic joint infections when paired with effective companion antibiotics, but findings have varied and optimal regimens remain uncertain.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fuzhou, Fujian
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Xinyu Fang, MD
- Email: fangxinyu0417@fjmu.edu.cn
- Phone: 86+18084768503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.