Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

NCT00719056 | Completed Phase 4

• 1 other identifier: TEICO01
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Total Hip and Knee Arthroplasties

Keywords

teicoplanin; prophylaxis; arthroplasty; surgical site infections

Outcome Measures

Primary Outcomes (1)

• 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.

  Two years

Secondary Outcomes (1)

• 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.

  Two years

Study Arms (2)

1

EXPERIMENTAL

Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty.

Drug: Teicoplanin

2

ACTIVE COMPARATOR

Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty.

Drug: β-lactams or ciprofloxacin

Interventions

Teicoplanin DRUG

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

Also known as: Glycopeptide

1

β-lactams or ciprofloxacin DRUG

Multiple doses for up to six consecutive days

Also known as: Cephalosporins or ciprofloxacin or penicillincs

2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Athens: lead
• KAT Hospital of Athens: collaborator

Study Sites (3)

2nd Department of Orthopedics, KAT Hospital

Marousi, Athens, 14527, Greece

Location

3rd Department of Orthopedics, KAT Hospital

Marousi, Athens, 14527, Greece

Location

4th Department of Orthopedics, KAT Hospital

Marousi, Athens, 14527, Greece

Location

Related Publications (3)

• Soriano A, Popescu D, Garcia S, Bori G, Martinez JA, Balasso V, Marco F, Almela M, Mensa J. Usefulness of teicoplanin for preventing methicillin-resistant Staphylococcus aureus infections in orthopedic surgery. Eur J Clin Microbiol Infect Dis. 2006 Jan;25(1):35-8. doi: 10.1007/s10096-005-0073-z.

  PMID: 16424973 BACKGROUND

• Wilson AP, Gruneberg RN, Neu H. Dosage recommendations for teicoplanin. J Antimicrob Chemother. 1993 Dec;32(6):792-6. doi: 10.1093/jac/32.6.792. No abstract available.

  PMID: 8144419 BACKGROUND

• Nehrer S, Thalhammer F, Schwameis E, Breyer S, Kotz R. Teicoplanin in the prevention of infection in total hip replacement. Arch Orthop Trauma Surg. 1998;118(1-2):32-6. doi: 10.1007/s004020050306.

  PMID: 9833102 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Teicoplanin; Glycopeptides; Ciprofloxacin; Cephalosporins

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipoglycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Study Officials

• Helen Giamarellou, MD, PhD

  4th Department of Internal Medicine, University of Athens, Medical School, Greece

  STUDY CHAIR

• Amyntas Varvaroussis, MD

  3rd Department of Orthopedics, KAT Hospital, Maroussi, Greece

  PRINCIPAL INVESTIGATOR

• Panagiotis Papadelis, MD

  2nd Department of Orthopedics, KAT Hospital, Maroussi, Greece

  PRINCIPAL INVESTIGATOR

• Vassilios Nikolaidis, MD

  4th Department of Orthopedics, KAT Hospital, Maroussi, Greece

  PRINCIPAL INVESTIGATOR

• Antonios Papadopoulos, MD, PhD

  4th Department of Internal Medicine, University of Athens, Medical School, Greece

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 21, 2008
• Study Start: August 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2007
• Last Updated: July 21, 2008

Record last verified: 2008-07

Locations

GR (3)