Rifampin-combined Antibiotic Therapy for Staphylococcal PJI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

428 Participants
are divided into 2 treatment groups
Group A: rifampicin combined with antibiotic treatment groupExperimental treatment 1 intervention
Group B: antibiotic treatment groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
two years postoperatively
2

Adverse events related to PJI

Time frame
Two years postoperatively

Secondary outcomes

1

Postoperative functional score

Time frame
Two years postoperatively
2

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

Time frame
Two years postoperatively
3

The incidence of antibiotic complications

Time frame
Two years postoperatively

Other outcomes

Sponsors and contacts

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