Periprosthetic Joint InfectionNCT07313215
Rifampin-combined Antibiotic Therapy for Staphylococcal PJI
A study testing Rifampicin (R) in people with Periprosthetic Joint Infection, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periprosthetic Joint Infection
- What is being tested?
- Rifampicin (R)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2025to 18 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Xinyu Fang, MD, 86+18084768503, fangxinyu0417@fjmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Periprosthetic Joint Infection
- Being tested
- Rifampicin (R)
- Keywords
- Periprosthetic Joint Infection, Debride ment, antibiotics, and implant retention, Revision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| rifampicin combined with antibiotic treatment group | Experimental | In the "rifampicin combined with antibiotic treatment" group, on the basis of conventional antibiotic treatment, rifampicin is taken orally for an additional three months Receives: Drug: Rifampicin (R) |
| antibiotic treatment group | Active comparator | In the "antibiotic treatment" group, conventional antibiotics alone are used for treatment Receives: Drug: Rifampicin (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years postoperatively
Adverse events related to PJI
Measured: Two years postoperatively
Secondary outcomes (3)
Postoperative functional score
Measured: Two years postoperatively
The rate of prosthesis loosening after surgery, the revision rate, and the proportion of prostheses that need to be removed
Measured: Two years postoperatively
The incidence of antibiotic complications
Measured: Two years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start13 Nov 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion18 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Fang, First Affiliated Hospital of Fujian Medical University
- Investigators
- Wenming Zhang, MD, Study director, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313215
- Sponsor's protocol ID
- MRCTA, ECFAH of FMU[2024]821-1
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Complications of Rifampin-combined Antibiotic Therapy for Staphylococcal Periprosthetic Joint Infections（PJI）: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07313215
- Acronym / sponsor ID
- MRCTA, ECFAH of FMU[2024]821-1
- Conditions
- Periprosthetic Joint Infection
- Keywords
- Periprosthetic Joint Infection, Debride ment, antibiotics, and implant retention, Revision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 18 Dec 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rifampicin combined with antibiotic treatment group | Experimental | 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 |
| antibiotic treatment group | Active comparator | Drug: Rifampicin (R)In the "antibiotic treatment" group, conventional antibiotics alone are used for treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as PJI according to the MSIS criteria
Key exclusion criteria (3 listed)
- Those with chronic inflammation in other parts of the body before the operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | antibiotic treatment group, rifampicin combined with antibiotic treatment group |
Primary outcome
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
Adverse events related to PJI
Time frame: Two years postoperatively
3 secondary outcomes
Postoperative functional score
Time frame: 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
The incidence of antibiotic complications
Time frame: Two years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenming Zhang, MD study director
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifampicin (R) in people with Periprosthetic Joint Infection, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyu Fang, MD (86+18084768503, fangxinyu0417@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clearance rate of infection, calculated by the formula (time frame: two years postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.