NCT07313215 Rifampin-combined Antibiotic Therapy for Staphylococcal PJI
| NCT ID | NCT07313215 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Fujian Medical University |
| Condition | Periprosthetic Joint Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 428 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 428 participants in total. It began in 2025-11-13 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Wenming Zhang, MD
STUDY DIRECTOR
First Affiliated Hospital of Fujian Medical University
Frequently Asked Questions
Who can join the NCT07313215 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Periprosthetic Joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07313215 currently recruiting?
Yes, NCT07313215 is actively recruiting participants. Contact the research team at fangxinyu0417@fjmu.edu.cn for enrollment information.
Where is the NCT07313215 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT07313215 clinical trial?
NCT07313215 is sponsored by First Affiliated Hospital of Fujian Medical University. The principal investigator is Wenming Zhang, MD at First Affiliated Hospital of Fujian Medical University. The trial plans to enroll 428 participants.