Periprosthetic Joint InfectionPACER-PJINCT05284318
Prospective Cohort Study on Antibiotic Course and Efficacy After Two-stage Revision in PJI.
An observational study of Periprosthetic Joint Infection and Anti-Bacterial Agents, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This is a multicenter prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before phase II revision surgery. Eligible patients will be included in this study after signing the informed consent form. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection, Anti-Bacterial Agents
- What is being tested?
- Antibiotics treatment
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent secondary replantation surgery for prosthetic joint infection at the First Affiliated Hospital of Fujian Medical University and other sub-centers were selected.
Who may be able to join
- 1. A diagnosis of PJI was made according to MSIS criteria. 2. Received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision.
- 3. Age ≥18 years old. 4. The patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. He has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study.
Who cannot join
- 1. Follow-up data not available. 2. Researchers judge that patients no longer meet the standards of the study due to compliance problems
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
Fang, Vice directors, 9738006@qq.com
About this study
Official title: Effect of Antibiotic Treatment Course on Clinical Outcome After Two-stage Revision of Prosthetic Joint Infection: A Prospective Cohort Study.
This is a multicenter prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before phase II revision surgery. Eligible patients will be included in this study after signing the informed consent form. After the second stage revision, according to the patient's symptoms and examination results, the attending physician used a reasonable antibiotic treatment scheme (including intravenous and oral medication). All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the time points of 1, 3, 6, 12, 18 and 24 months after the start of antibiotic treatment after phase II revision. The infection control rate of patients was evaluated by follow-up at least 2 years after operation, so as to analyze the effect of antibiotic treatment course after two-stage revision of periprosthetic joint infection.
Read the detailed description
Inclusion criteria：
- A diagnosis of PJI was made according to MSIS criteria
- Received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision.
- Age ≥18 years old
- The patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. He has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study.
Exclusion criteria：
- Follow up data were not available;
- The investigator judged that the patient no longer met the criteria of the study due to compliance problems.
Recruiting time：2021.10 -2023.10.31 Interventions Group：No Sample size：500 Study Population Description: Patients who underwent secondary replantation surgery for prosthetic joint infection at the First Affiliated Hospital of Fujian Medical University and other sub-centers were selected.
- Being tested
- Antibiotics treatment
- Keywords
- Periprosthetic joint infection, Second-stage revision, Anti-Bacterial Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics treatmentDrug
After receiving intravenous antibiotics treatment for 2 weeks, and clinician determines whether to continue with any antibiotics.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance rate of infection
Number of subjects with infection cleared/total number of subjects who completed follow-up
Measured: 31, December，2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Fang, First Affiliated Hospital of Fujian Medical University
- Investigators
- Zhang, Director, Study director, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284318
- Sponsor's protocol ID
- MRCTA ECFAH of FMU 2021404
- Acronym
- PACER-PJI
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Within six months after the trial complete
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antibiotic Treatment Course on Clinical Outcome After Two-stage Revision of Prosthetic Joint Infection: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05284318
- Acronym / sponsor ID
- PACER-PJI / MRCTA ECFAH of FMU 2021404
- Keywords
- Periprosthetic joint infection, Second-stage revision, Anti-Bacterial Agents
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Mar 2022 (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 multicenter prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before phase II revision surgery. Eligible patients will be included in this study after signing the informed consent form. After the second stage revision, according to the patient's symptoms and examination results, the attending physician used a reasonable antibiotic treatment scheme (including intravenous and oral medication). All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the time points of 1, 3, 6, 12, 18 and 24 months after the start of antibiotic treatment after phase II revision. The infection control rate of patients was evaluated by follow-up at least 2 years after operation, so as to analyze the effect of antibiotic treatment course after two-stage revision of periprosthetic joint infection.
Detailed description
Inclusion criteria：
- A diagnosis of PJI was made according to MSIS criteria
- Received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision.
- Age ≥18 years old
- The patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. He has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study.
Exclusion criteria：
- Follow up data were not available;
- The investigator judged that the patient no longer met the criteria of the study due to compliance problems.
Recruiting time：2021.10 -2023.10.31 Interventions Group：No Sample size：500 Study Population Description: Patients who underwent secondary replantation surgery for prosthetic joint infection at the First Affiliated Hospital of Fujian Medical University and other sub-centers were selected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent secondary replantation surgery for prosthetic joint infection at the First Affiliated Hospital of Fujian Medical University and other sub-centers were selected.
Key inclusion criteria (2 listed)
- 1. A diagnosis of PJI was made according to MSIS criteria. 2. Received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision.
- 3. Age ≥18 years old. 4. The patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. He has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study.
Key exclusion criteria (1 listed)
- 1. Follow-up data not available. 2. Researchers judge that patients no longer meet the standards of the study due to compliance problems
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 |
|---|---|---|
| Antibiotics treatmentAfter receiving intravenous antibiotics treatment for 2 weeks, and clinician determines whether to continue with any antibiotics. | Drug | – |
Primary outcome
Clearance rate of infection
Time frame: 31, December，2026
Number of subjects with infection cleared/total number of subjects who completed follow-up
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 17 Mar 2022.
- Individual participant dataSharing planned: Undecided. Within six months after the trial complete
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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.
Zhang, Director 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?
An observational study of Periprosthetic Joint Infection and Anti-Bacterial Agents, 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 2 inclusion and 1 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 17 Mar 2022. 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 Fang (18084768503 ext. 86, 9738006@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance rate of infection (time frame: 31, December，2026). 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 17 Mar 2022; AzTrials last refreshed its copy on 3 Nov 2026.