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

NCT06189885 | Not Yet Recruiting

• 1 other identifier: 202301864A3
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Infection

  Infection that meets the 2018 ICM criteria after second stage reimplantation.

  One year

Secondary Outcomes (1)

• Acute Kidney Injury

  48 hours

Study Arms (2)

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

Interventions

Cefazolin with Daptomycin 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 Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty

Cefazolin with vancomycin 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.

Preoperative Vancomycin Prophylaxis in Two-Stage Exchange Arthroplasty

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Interventions

Cefazolin; Daptomycin; Vancomycin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Glycopeptides; Glycoconjugates; Carbohydrates

Central Study Contacts

Feng-Chih Kuo, MD

CONTACT

886-7-7317123; fongchikuo@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 5, 2024

Record last verified: 2023-11

Locations

TW (1)