Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty: A Prospective, Randomized, Double-Blinded Trial

Periprosthetic Joint Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06189885
• Other study ID #: 202301864A3
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: November 2023
• Source: Chang Gung Memorial Hospital
• Contact: Feng-Chih Kuo, MD
• Phone: 886-7-7317123
• Email: fongchikuo[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Will undergo a second stage of reimplantation.

Exclusion Criteria:

1. Patients with a fungal infection or culture-negative infections

2. Known allergies to Cefazolin, Daptomycin, or Vancomycin.

3. Currently receiving surgical treatment for acute postoperative or acute hematogenous PJI.

4. Chronic kidney disease (Creatinine Clearance Rate [CCR] < 30 ml/min/1.73m2)

Related Conditions & MeSH terms

• Infections
• Periprosthetic Joint Infection

Intervention

Drug:
• Cefazolin with Daptomycin
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 vancomycin
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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection	Infection that meets the 2018 ICM criteria after second stage reimplantation.	One year
Secondary	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.	48 hours