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

NCT ID: NCT06189885

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-07-31

Brief 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).

Conditions

Periprosthetic Joint Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty

Group Type: EXPERIMENTAL

Cefazolin with Daptomycin

Intervention Type: DRUG

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.

Preoperative Vancomycin Prophylaxis in Two-Stage Exchange Arthroplasty

Group Type: EXPERIMENTAL

Cefazolin with vancomycin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Central Contacts

Feng-Chih Kuo, MD

Role: CONTACT

fongchikuo@cgmh.org.tw

886-7-7317123

Other Identifiers

202301864A3

Identifier Type: -

Identifier Source: org_study_id