Actively Recruiting
The Efficacy and Complications of Rifampin-combined Antibiotic Therapy for Staphylococcal Periprosthetic Joint Infections (PJI): A Multicenter, Randomized Controlled Trial
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2025-12-31
428
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of rifampicin combined with antibiotics to treat periprosthetic joint infections (PJI) caused by staphylococcus bacteria. This multicenter, randomized controlled study focuses on patients who have undergone DAIR surgery and aims to compare infection control rates and safety between two treatment approaches over at least a two-year follow-up period. The study follows CONSORT guidelines and ensures ethical approval and informed consent from participants. After surgery, all patients receive intravenous antibiotics for 1 to 2 weeks. Then, they are randomly assigned to one of two groups: one group receives conventional antibiotics (fluoroquinolones or linezolid) for 3 months based on microbial culture results, while the other group receives the same antibiotics plus oral rifampicin for 3 months. Both groups are monitored to assess the differences in infection control and safety outcomes. Participants will undergo regular assessments including infection recurrence rates, inflammatory markers, prosthesis function recovery, and monitoring for drug side effects. Data is collected through a unified system and analyzed at the study's end. The primary outcomes include infection clearance and adverse events related to PJI two years after surgery. Secondary outcomes include functional scores, prosthesis loosening, revision rates, prosthesis removal, and antibiotic complications. The study duration per participant covers at least two years of follow-up.
CONDITIONS
Brief Title
Rifampin-combined Antibiotic Therapy for Staphylococcal PJI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with periprosthetic joint infection according to MSIS criteria
- Staphylococcus identified as the pathogen through culture and drug sensitivity tests
- Complete clinical data available
- Age under 80 years old without serious complications or immunosuppressive status
- Voluntarily agreed to participate, physically and mentally able to tolerate treatment and tests
- Signed informed consent and passed ethics committee review
You will not qualify if you...
- Chronic inflammation in other parts of the body before surgery
- Non-staphylococcal infection or mixed infection
- Other diseases affecting outcome such as immune deficiency or liver and kidney dysfunction
- Expected lifespan of less than six months
- Determined by researcher as non-compliant with study criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either rifampicin combined with conventional antibiotic treatment or conventional antibiotic treatment alone for periprosthetic joint infection following surgical treatment.
Regular visits for treatment and safety assessments during the 3-month treatment period
Duration - Up to 2 years postoperatively
Participants are systematically followed to assess infection clearance, prosthesis function recovery, and monitor for adverse events and complications related to treatment.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
X
Xinyu Fang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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