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

Not Applicable

Not yet recruiting

• Conditions: Periprosthetic Joint Infection
• Interventions: Drug: Cefazolin with vancomycin; Drug: Cefazolin with Daptomycin

• Registration Number: NCT06189885
• Lead Sponsor: Chang Gung Memorial Hospital

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Study Start: 2024-08-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 184

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preoperative Vancomycin Prophylaxis in Two-Stage Exchange Arthroplasty	Cefazolin with vancomycin	-
Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty	Cefazolin with Daptomycin	-

Primary Outcome Measures

Name	Time	Method
Infection	One year	Infection that meets the 2018 ICM criteria after second stage reimplantation.

Secondary Outcome Measures

Name	Time	Method
Acute Kidney Injury	48 hours	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.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan