Rifampin-combined Antibiotic Therapy for Staphylococcal PJI

December 17, 2025 updated by: Xinyu Fang, First Affiliated Hospital of Fujian Medical University

The Efficacy and Complications of Rifampin-combined Antibiotic Therapy for Staphylococcal Periprosthetic Joint Infections（PJI）: A Multicenter, Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to evaluate the efficacy and safety of combined rifampicin for antibiotic treatment in patients with PJI after surgical treatment Sex. The research subjects were PJI patients with staphylococcus as the pathogen. After receiving DAIR treatment, they were screened and enrolled according to strict inclusion and exclusion criteria and randomly assigned to the rifampicin combined with antibiotic treatment group or the conventional antibiotic treatment group only. Then, systematic follow-up was conducted on the patients. Regularly assess its safety indicators such as the recurrence rate of infection, inflammatory indicators, prosthesis function recovery and drug side effects. The data will be entered through a unified recording system and patients who do not meet the research design will be excluded according to the predetermined exit criteria. After the follow-up, the data were summarized and analyzed, with a focus on examining the differences in the efficacy and safety of rifampicin combined therapy in controlling PJI infection. Through this study, we hope to clarify the efficacy and safety of rifampicin combined with antibiotics in PJI treatment, thereby providing a reference basis for the optimization of antibiotic regimens for PJI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
428

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: rifampicin combined with antibiotic treatment group
In the "rifampicin combined with antibiotic treatment" group, on the basis of conventional antibiotic treatment, rifampicin is taken orally for an additional three months
Drug: Rifampicin (R)
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
Active Comparator: antibiotic treatment group
In the "antibiotic treatment" group, conventional antibiotics alone are used for treatment
Drug: Rifampicin (R)
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The clearance rate of infection, calculated by the formula
Time Frame: two years postoperatively
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
two years postoperatively
Adverse events related to PJI
Time Frame: Two years postoperatively
Two years postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Postoperative functional score
Time Frame: Two years postoperatively
Two years postoperatively
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
Two years postoperatively
The incidence of antibiotic complications
Time Frame: Two years postoperatively
Two years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Fujian Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Wenming Zhang, MD, First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRCTA, ECFAH of FMU[2024]821-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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