Official Title: “Efficacy of Teicoplanin for the Prevention of Surgical Site Infections After Total Hip or Knee Arthroplasty: A Prospective, Open-Label Randomized Study”

This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with teicoplanin or with other antibiotics. The study is aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2005

This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with a single dose of teicoplanin or with multiple doses of other antibiotics according to the habits of the attending physicians aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections

Intervention(s) in this Clinical Trial

• Drug: Teicoplanin
  • The selected dose was 10mg/kg and it was given intravenously by a catheter inserted under aseptic conditions in a forearm vein within 15 minutes; it was diluted in one 5% glucose solution of a 50 ml final volume
• Drug: β-lactams or ciprofloxacin
  • Multiple doses for up to six consecutive days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty.
• Active Comparator: 2
  • Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty.

Primary Measures

• To compare the efficacy of single dose teicoplanin compared with comparator agents in the prevention of surgical site infections after total hip or knee arthroplasty.
  • Time Frame: Two years
    Safety Issue?: No

Secondary Measures

• To compare the efficacy of single dose teicoplanin compared with comparator agents in the separate prevention of superficial or deep surgical site infections after total hip or knee arthroplasty.
  • Time Frame: Two years
    Safety Issue?: No

Inclusion Criteria:

• Patients admitted for total hip arthroplasty
• Patients admitted for total knee arthroplasty

Exclusion Criteria:

• Revision arthroplasty
• History of any infection within the preceding two months
• History of an operation in the same hip or knee for other causes
• Known history of allergy to the studied drug
• Pregnancy or lactation
• Any antibiotic therapy in the week before operation.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Athens

Overall Clinical Trial Officials and Contacts

Helen Giamarellou, MD, PhD Study Chair 4th Department of Internal Medicine, University of Athens, Medical School, Greece  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00719056

Study ID Number: TEICO01

ClinicalTrials.gov Identifier: NCT00719056

Health Authority: Greece: National Organization of Medicines