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NCT Number: NCT06189885

Preoperative Daptomycin Prophylaxis 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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Infection

    Time frame: One year

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

Secondary outcomes

  1. Acute Kidney Injury

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Feng-Chih Kuo, MD

CONTACT

[email protected]

886-7-7317123

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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