Periprosthetic Joint InfectionNCT06189885
Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty: A Prospective, Randomized, Double-Blinded Trial
A study testing Cefazolin with Daptomycin and Cefazolin with vancomycin in people with Periprosthetic Joint Infection, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The gold standard for treating prosthetic joint infection (PJI) is two-stage exchange arthroplasty. This includes the first stage of debridement and removal of the artificial joint, and the second stage of reimplantation of the artificial joint. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Periprosthetic Joint Infection
- What is being tested?
- Cefazolin with Daptomycin and Cefazolin with vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older with an infection that meets the 2018 International Consensus Meeting (ICM) criteria7 at the time of the first-stage resection arthroplasty with a gram-positive organism, especially MRSA.
- Will undergo a second stage of reimplantation.
Who cannot join
- Patients with a fungal infection or culture-negative infections
- Known allergies to Cefazolin, Daptomycin, or Vancomycin.
- Currently receiving surgical treatment for acute postoperative or acute hematogenous PJI.
- Chronic kidney disease (Creatinine Clearance Rate [CCR] < 30 ml/min/1.73m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Daptomycin Prophylaxis for Preventing Gram-Positive or Methicillin-Resistant Staphylococcus Aureus Infection in Two-Stage Exchange Arthroplasty: A Prospective, Randomized, Double-Blinded Trial
The gold standard for treating prosthetic joint infection (PJI) is two-stage exchange arthroplasty. This includes the first stage of debridement and removal of the artificial joint, and the second stage of reimplantation of the artificial joint. Methicillin-resistant staphylococcus aureus (MRSA) infection is one of the factors leading to the failure of artificial joint infection treatment. Before the second stage of the joint surgery, the surgeon will prescribe prophylactic antibiotics based on previous bacterial cultures. The usual preoperative antibiotic is a first-generation cephalosporin antibiotic. If it is MRSA, vancomycin will be given. Increasingly, literature reports link prosthetic joint infections to MRSA, but no changes have been made to the routine recommendation for MRSA prophylactic antibiotic use.
Daptomycin is a cyclic lipopeptide antibiotic that can rapidly penetrate biofilms and bones, and its safety and tolerability have been confirmed. Therefore, it can effectively combat Gram-positive organisms, including MRSA. Daptomycin has many characteristics of an ideal prophylactic: short infusion time, low adverse events during administration, and a range limited to Gram-positive organisms. We aim to assess whether adding antibiotics that cover MRSA would reduce prosthetic joint infections and increase surgical success rates, in addition to the standard recommended prophylactic antibiotics. Thus, this prospective randomized trial is designed to assess, besides using the first-generation cephalosporin antibiotic, the effects of adding an antibiotic with MRSA coverage (Daptomycin vs. Vancomycin).
- Conditions
- Periprosthetic Joint Infection
- Being tested
- Cefazolin with Daptomycin, Cefazolin with vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin with DaptomycinDrug
For patients randomized to receive daptomycin (8 mg/kg), the drug will be administered in a 50 cc bag, accompanied by a 500 cc bag of normal saline within 60 minutes before surgical incision and discontinued after 24 hours postoperatively.
Cefazolin with vancomycinDrug
Then vancomycin (15 mg/kg) will concurrently be given and completed within 60 minutes before surgical incision and discontinued after 24 hours postoperatively9. Patients in the vancomycin arm will receive this drug in a 50 cc bag accompanied by a 500 cc bag of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty | Experimental | Not described Receives: Drug: Cefazolin with Daptomycin |
| Preoperative Vancomycin Prophylaxis in Two-Stage Exchange Arthroplasty | Experimental | Not described Receives: Drug: Cefazolin with vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
Infection that meets the 2018 ICM criteria after second stage reimplantation.
Measured: One year
Secondary outcomes (1)
Acute Kidney Injury
efined by the Kidney Disease Improving Global Outcomes (KDIGO)11, which includes a rise in serum creatinine by ≥0.3 mg/dl within 48 hours; or an increase in serum creatine ≥1.5 times the patient's preoperative baseline within 7 days; or urine volume <0.5 ml/kg/h for 6 hours.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 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 Chang Gung Memorial HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189885
- Sponsor's protocol ID
- 202301864A3
- Status last verified
- Nov 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Daptomycin Prophylaxis for Preventing Gram-Positive or Methicillin-Resistant Staphylococcus Aureus Infection in Two-Stage Exchange Arthroplasty: A Prospective, Randomized, Double-Blinded Trial
- ClinicalTrials.gov ID
- NCT06189885
- Acronym / sponsor ID
- 202301864A3
- Conditions
- Periprosthetic Joint Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
The gold standard for treating prosthetic joint infection (PJI) is two-stage exchange arthroplasty. This includes the first stage of debridement and removal of the artificial joint, and the second stage of reimplantation of the artificial joint. Methicillin-resistant staphylococcus aureus (MRSA) infection is one of the factors leading to the failure of artificial joint infection treatment. Before the second stage of the joint surgery, the surgeon will prescribe prophylactic antibiotics based on previous bacterial cultures. The usual preoperative antibiotic is a first-generation cephalosporin antibiotic. If it is MRSA, vancomycin will be given. Increasingly, literature reports link prosthetic joint infections to MRSA, but no changes have been made to the routine recommendation for MRSA prophylactic antibiotic use.
Daptomycin is a cyclic lipopeptide antibiotic that can rapidly penetrate biofilms and bones, and its safety and tolerability have been confirmed. Therefore, it can effectively combat Gram-positive organisms, including MRSA. Daptomycin has many characteristics of an ideal prophylactic: short infusion time, low adverse events during administration, and a range limited to Gram-positive organisms. We aim to assess whether adding antibiotics that cover MRSA would reduce prosthetic joint infections and increase surgical success rates, in addition to the standard recommended prophylactic antibiotics. Thus, this prospective randomized trial is designed to assess, besides using the first-generation cephalosporin antibiotic, the effects of adding an antibiotic with MRSA coverage (Daptomycin vs. Vancomycin).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty | Experimental | Drug: Cefazolin with Daptomycin |
| Preoperative Vancomycin Prophylaxis in Two-Stage Exchange Arthroplasty | Experimental | Drug: Cefazolin with vancomycin |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 or older with an infection that meets the 2018 International Consensus Meeting (ICM) criteria7 at the time of the first-stage resection arthroplasty with a gram-positive organism, especially MRSA.
- Will undergo a second stage of reimplantation.
Key exclusion criteria (4 listed)
- Patients with a fungal infection or culture-negative infections
- Known allergies to Cefazolin, Daptomycin, or Vancomycin.
- Currently receiving surgical treatment for acute postoperative or acute hematogenous PJI.
- Chronic kidney disease (Creatinine Clearance Rate [CCR] < 30 ml/min/1.73m2)
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 |
|---|---|---|
| Cefazolin with DaptomycinFor patients randomized to receive daptomycin (8 mg/kg), the drug will be administered in a 50 cc bag, accompanied by a 500 cc bag of normal saline within 60 minutes before surgical incision and discontinued after 24 hours postoperatively. | Drug | Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty |
| Cefazolin with vancomycinThen vancomycin (15 mg/kg) will concurrently be given and completed within 60 minutes before surgical incision and discontinued after 24 hours postoperatively9. Patients in the vancomycin arm will receive this drug in a 50 cc bag accompanied by a 500 cc bag of normal saline. | Drug | Preoperative Vancomycin Prophylaxis in Two-Stage Exchange Arthroplasty |
Primary outcome
Infection
Time frame: One year
Infection that meets the 2018 ICM criteria after second stage reimplantation.
1 secondary outcome
Acute Kidney Injury
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin with Daptomycin and Cefazolin with vancomycin in people with Periprosthetic Joint Infection, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng-Chih Kuo, MD (886-7-7317123, fongchikuo@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection (time frame: One year). 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 5 Jan 2024.