Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07313215

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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